MEDIA
NEWS
RELEASE
The United States: US Medical Device Tax One Step Closer to Repeal
The US Senate has joined the House in approving a new federal budget that includes provisions to repeal the Medical Device Excise Tax (MDET).
The budget bill now goes to President Obama for final approval; he has indicated he will sign the bill.
It must be emphasized that the MDET repeal language in the budget is non-binding; this would mean that legislators would have more leverage--reallocating money from other government programs, for example, instead of raising or creating new taxes--to come up with alternate revenues to replace the healthcare funding generated by MDET. Congress would first have to identify and approve that alternate revenue source before shutting down MDET.
MDET opponents in the Senate continue to push a separate bill, the Medical Device Access & Innovation Protection Act, that would repeal the medical device sales tax outright, but any repeal effort that does not include an alternative funding source won't likely be supported by Obama. Although the language in the new budget does not mean immediate victory for MDET opponents, it does provide a more politically viable path to repeal.
27 DEC 2013
The United States: US Medical Device Tax One Step Closer to Repeal
The US Senate has joined the House in approving a new federal budget that includes provisions to repeal the Medical Device Excise Tax (MDET).
The budget bill now goes to President Obama for final approval; he has indicated he will sign the bill.
It must be emphasized that the MDET repeal language in the budget is non-binding; this would mean that legislators would have more leverage--reallocating money from other government programs, for example, instead of raising or creating new taxes--to come up with alternate revenues to replace the healthcare funding generated by MDET. Congress would first have to identify and approve that alternate revenue source before shutting down MDET.
MDET opponents in the Senate continue to push a separate bill, the Medical Device Access & Innovation Protection Act, that would repeal the medical device sales tax outright, but any repeal effort that does not include an alternative funding source won't likely be supported by Obama. Although the language in the new budget does not mean immediate victory for MDET opponents, it does provide a more politically viable path to repeal.
India: India raises natural rubber import duty by 50%, M'sia major exporter
India has raised import duties on natural rubber by 50 percent to curb rising imports that pushed local prices to their lowest in 3-1/2 years, the government said in a statement.
The government has fixed import duty at 30 rupees per kg, or 20 percent, whichever is lower, the statement said. India, the world's fourth largest rubber producer, was earlier charging a duty of 20 rupees per kg, or 20 percent, whichever was lower.
Domestic rubber prices hit a 3-1/2-year low of 150 rupees per kg earlier this month as tyre makers trimmed purchases from local market due to higher imports.
Indian natural rubber imports in the first eight months of the financial year that started on April 1, 2013 were 53 percent higher on year at 237,723 tonnes.
The south Asian country imports natural rubber from Malaysia, Thailand and Indonesia.
The government said the higher import duty would support nearly 1.2 million farmers dependent on the crop for their livelihood. – Reuters
27 DEC 2013
India: India raises natural rubber import duty by 50%, M'sia major exporter
India has raised import duties on natural rubber by 50 percent to curb rising imports that pushed local prices to their lowest in 3-1/2 years, the government said in a statement.
The government has fixed import duty at 30 rupees per kg, or 20 percent, whichever is lower, the statement said. India, the world's fourth largest rubber producer, was earlier charging a duty of 20 rupees per kg, or 20 percent, whichever was lower.
Domestic rubber prices hit a 3-1/2-year low of 150 rupees per kg earlier this month as tyre makers trimmed purchases from local market due to higher imports.
Indian natural rubber imports in the first eight months of the financial year that started on April 1, 2013 were 53 percent higher on year at 237,723 tonnes.
The south Asian country imports natural rubber from Malaysia, Thailand and Indonesia.
The government said the higher import duty would support nearly 1.2 million farmers dependent on the crop for their livelihood. – Reuters
Rubber glove sector unfazed by cost spikes
KUCHING: Malaysia continues to see healthy sales volume growth for rubber gloves in the first nine months of 2013 (9M13) in tandem with growing global demand, further aided by the cheaper average selling prices (ASP) thanks to the subdued raw material prices.
According to the research group at JF Apex Securities Bhd (JF Apex Research), the increase in sales volume was reflected in the top line of local manufacturers with the exception of Top Glove Corporation Bhd, mainly due to its lower ASP while it was also in the transition period to rebalance its product mix.
“On average, the industry registered eight per cent of top line growth in 9M13 which we deem sustainable going forward,†noted the research house.
JF Apex Research also added that prices of raw material, the biggest component in rubber glove manufacturing costs at circa 50 to 60 per cent were in subdued form in 2013.
As of 9M13, nitrile and latex price have declined 24 per cent y-o-y and 17 per cent year on year (y-o-y) respectively, as demand on the commodity failed to pick up due to the slow growth in global economy.
As a result, glove manufacturers managed to capitalise on weak raw material prices by offsetting the cost spikes arose from the implementation of minimum wage earlier this year.
China, as the world largest automotives market, is set to grow at 8.8 per cent in 2013 to 21 million units following the recovery in sales volume seen in 2H13 as the territorial dispute between China and Japan that sparked boycotts against Japanese products cooled off.
“The demand switch from latex gloves to nitrile gloves remained strong as the nitrile gloves exported from Malaysia grew at three-year compound annual growth rate (CAGR) of 36.6 per cent in 2009-2012 while the contribution of the nitrile gloves to total glove export rose to 46 per cent in 2012, up from 22 per cent back in 2012,†explained the research house.
“Together with its higher profitability due to its lighter weight, manufacturers in the industry are induced to ramp up their production capacity in the related field.
“We estimate an extra 14.9 billion pieces of new capacity to be added to the industry by the four listed manufacturers in 2014, which represents an increase of 15.6 per cent from their existing total production capacity installed in 2013.
“However, we are cautious on the chances of all additional capacity to be fully absorbed by the market.
“Hence, we expect manufacturers to adopt aggressive price strategy to fight for market share as the competition heightens going forward, as well as plan their capacity expansion wisely to be in tandem with the market growth,†it added.
Following the implementation of minimum wage early this year, the electricity tariff was revised upward by circa 17 per cent in November whilst the gas price revision is set to follow suit.
While the impact to the manufacturing cost spike varies according to their weightage, JF Apex reckon that the Malaysia’s glove manufacturers will be inevitably losing certain ground in the sense of competitiveness and cost effectiveness to the peers in China, Indonesia and Thailand.
“However, we opine that the local glove maker still hold the edge with their superior expertise and advanced technology level, while the aggressive large scale expansion is not matched by the regional peers.
“In a nutshell, Malaysia is still in a strong position to maintain its lion share in the global market of 63 to 64 per cent in the near future in view of its conducive environment in spite of the cost inflation, hence the manufacturers will still be able to pass through the extra costs to their customers.â€
20 DEC 2013
Rubber glove sector unfazed by cost spikes
KUCHING: Malaysia continues to see healthy sales volume growth for rubber gloves in the first nine months of 2013 (9M13) in tandem with growing global demand, further aided by the cheaper average selling prices (ASP) thanks to the subdued raw material prices.
According to the research group at JF Apex Securities Bhd (JF Apex Research), the increase in sales volume was reflected in the top line of local manufacturers with the exception of Top Glove Corporation Bhd, mainly due to its lower ASP while it was also in the transition period to rebalance its product mix.
“On average, the industry registered eight per cent of top line growth in 9M13 which we deem sustainable going forward,†noted the research house.
JF Apex Research also added that prices of raw material, the biggest component in rubber glove manufacturing costs at circa 50 to 60 per cent were in subdued form in 2013.
As of 9M13, nitrile and latex price have declined 24 per cent y-o-y and 17 per cent year on year (y-o-y) respectively, as demand on the commodity failed to pick up due to the slow growth in global economy.
As a result, glove manufacturers managed to capitalise on weak raw material prices by offsetting the cost spikes arose from the implementation of minimum wage earlier this year.
China, as the world largest automotives market, is set to grow at 8.8 per cent in 2013 to 21 million units following the recovery in sales volume seen in 2H13 as the territorial dispute between China and Japan that sparked boycotts against Japanese products cooled off.
“The demand switch from latex gloves to nitrile gloves remained strong as the nitrile gloves exported from Malaysia grew at three-year compound annual growth rate (CAGR) of 36.6 per cent in 2009-2012 while the contribution of the nitrile gloves to total glove export rose to 46 per cent in 2012, up from 22 per cent back in 2012,†explained the research house.
“Together with its higher profitability due to its lighter weight, manufacturers in the industry are induced to ramp up their production capacity in the related field.
“We estimate an extra 14.9 billion pieces of new capacity to be added to the industry by the four listed manufacturers in 2014, which represents an increase of 15.6 per cent from their existing total production capacity installed in 2013.
“However, we are cautious on the chances of all additional capacity to be fully absorbed by the market.
“Hence, we expect manufacturers to adopt aggressive price strategy to fight for market share as the competition heightens going forward, as well as plan their capacity expansion wisely to be in tandem with the market growth,†it added.
Following the implementation of minimum wage early this year, the electricity tariff was revised upward by circa 17 per cent in November whilst the gas price revision is set to follow suit.
While the impact to the manufacturing cost spike varies according to their weightage, JF Apex reckon that the Malaysia’s glove manufacturers will be inevitably losing certain ground in the sense of competitiveness and cost effectiveness to the peers in China, Indonesia and Thailand.
“However, we opine that the local glove maker still hold the edge with their superior expertise and advanced technology level, while the aggressive large scale expansion is not matched by the regional peers.
“In a nutshell, Malaysia is still in a strong position to maintain its lion share in the global market of 63 to 64 per cent in the near future in view of its conducive environment in spite of the cost inflation, hence the manufacturers will still be able to pass through the extra costs to their customers.â€
Malaysian JV to build green rubber facility
GREEN Rubber Asean, a JV between Malaysia-based global developer of green technologies Green Rubber Global Ltd and ACB Rubber Pte Ltd will be set up to undertake research, development and production of green rubber compound and its derivatives across the Asean region.
The RM20 million facility will be set up in Port Klang, and will have an initial production capacity of 10,000 tonnes/year.
In a statement, Datuk Vinod Sekhar, founder and chairman of Green Rubber Global Group, said that Malaysia was chosen to establish the first major production facility because the technology was the lifetime work of his late father Tan Sri Dr B. C. Sekhar
20 DEC 2013
Malaysian JV to build green rubber facility
GREEN Rubber Asean, a JV between Malaysia-based global developer of green technologies Green Rubber Global Ltd and ACB Rubber Pte Ltd will be set up to undertake research, development and production of green rubber compound and its derivatives across the Asean region.
The RM20 million facility will be set up in Port Klang, and will have an initial production capacity of 10,000 tonnes/year.
In a statement, Datuk Vinod Sekhar, founder and chairman of Green Rubber Global Group, said that Malaysia was chosen to establish the first major production facility because the technology was the lifetime work of his late father Tan Sri Dr B. C. Sekhar
Malaysia: Medical device exporters get good response
PETALING JAYA: The recent international medicine trade fair, Medica 2013, in Germany saw Malaysian medical devices exporters generate sales totalling RM76.9mil.
Malaysia External Trade Development Corp (Matrade) said in a statement yesterday that Malaysia, with its market leadership in product sectors such as medical latex gloves, surgical instruments and condoms, had attracted much interest from buyers at the exhibition.
“Malaysia accounted for 48.3% of the German market for latex medical gloves in 2012, generating export revenue of over RM600mil,†it said.
Matrade said that Medica 2013, which was held from Nov 20 to 23, had a record number of 42 Malaysian exhibitors.
“This year Matrade brought together 13 Malaysian companies at the ‘Malaysia Pavilion’ to introduce their medical products and technologies to the world market,†it said.
Matrade added that about 600 business meetings took place between the 13 Malaysian companies and foreign buyers.
Medica offered throughout the four-day event conferences and courses providing training on topics for practitioners, devices and high-level scientific workshops as well as seminars organised by exhibitor organisations and associations giving an update on latest European regulations on the import of medical devices.
“In total, 132,000 trade visitors from more than 120 countries were present at this year’s Medica, while 4,641 exhibitors represented 66 countries,†it said.
Matrade’s first event to promote medical devices next year will be the Arab Health 2014 to be held in Dubai, the United Arab Emirates, from Jan 27 to 30.
10 DEC 2013
Malaysia: Medical device exporters get good response
PETALING JAYA: The recent international medicine trade fair, Medica 2013, in Germany saw Malaysian medical devices exporters generate sales totalling RM76.9mil.
Malaysia External Trade Development Corp (Matrade) said in a statement yesterday that Malaysia, with its market leadership in product sectors such as medical latex gloves, surgical instruments and condoms, had attracted much interest from buyers at the exhibition.
“Malaysia accounted for 48.3% of the German market for latex medical gloves in 2012, generating export revenue of over RM600mil,†it said.
Matrade said that Medica 2013, which was held from Nov 20 to 23, had a record number of 42 Malaysian exhibitors.
“This year Matrade brought together 13 Malaysian companies at the ‘Malaysia Pavilion’ to introduce their medical products and technologies to the world market,†it said.
Matrade added that about 600 business meetings took place between the 13 Malaysian companies and foreign buyers.
Medica offered throughout the four-day event conferences and courses providing training on topics for practitioners, devices and high-level scientific workshops as well as seminars organised by exhibitor organisations and associations giving an update on latest European regulations on the import of medical devices.
“In total, 132,000 trade visitors from more than 120 countries were present at this year’s Medica, while 4,641 exhibitors represented 66 countries,†it said.
Matrade’s first event to promote medical devices next year will be the Arab Health 2014 to be held in Dubai, the United Arab Emirates, from Jan 27 to 30.
Indonesia: Indonesia rubber group calls for 10 pct cut in output
Indonesia's main rubber grouping is calling on the world's second largest producer to cut output next year by 10 percent, while urging other Southeast Asia rubber-growing countries to do the same to reduce global stocks and support prices.
Tokyo rubber futures, which set the tone for physical rubber prices in Southeast Asia, have dropped nearly 10 percent this year on concerns about the global economy and as regional supplies have swelled.
Rubber inventories in world top consumer China monitored by the Shanghai Futures Exchange fell more than 10 percent last week, but remain at near nine-year highs.
06 DEC 2013
Indonesia: Indonesia rubber group calls for 10 pct cut in output
Indonesia's main rubber grouping is calling on the world's second largest producer to cut output next year by 10 percent, while urging other Southeast Asia rubber-growing countries to do the same to reduce global stocks and support prices.
Tokyo rubber futures, which set the tone for physical rubber prices in Southeast Asia, have dropped nearly 10 percent this year on concerns about the global economy and as regional supplies have swelled.
Rubber inventories in world top consumer China monitored by the Shanghai Futures Exchange fell more than 10 percent last week, but remain at near nine-year highs.
India: Rubber Board demands a ban on natural rubber import
KOCHI: The executive committee of the Rubber Board, which met to discuss issues related to rubber price demanded a ban on rubber import. If that was not possible the meeting called for temporary suspension of imports against advance license (duty free import).
Another suggestion raised in the meeting was to raise the import duty to 25 per cent without imposing any cap on the maximum limit. The members also urged the central and state governments to implement a scheme for joint procurement of rubber. It was also suggested that the purchase tax of 5 per cent levied by the Kerala government be reduced.
The meeting wanted maximum publicity to be given to measures such as road rubberisation, and steps to restructure the price stabilization fund so as to make it more beneficial to the growers.
Rubber Board chairman, Sheela Thomas, who presided over the meeting, informed the members that the sentiments expressed by them would be brought to the notice of the Central Government and the board would spare no efforts to take the maximum possible measures within its jurisdiction, in this regard.
05 DEC 2013
India: Rubber Board demands a ban on natural rubber import
KOCHI: The executive committee of the Rubber Board, which met to discuss issues related to rubber price demanded a ban on rubber import. If that was not possible the meeting called for temporary suspension of imports against advance license (duty free import).
Another suggestion raised in the meeting was to raise the import duty to 25 per cent without imposing any cap on the maximum limit. The members also urged the central and state governments to implement a scheme for joint procurement of rubber. It was also suggested that the purchase tax of 5 per cent levied by the Kerala government be reduced.
The meeting wanted maximum publicity to be given to measures such as road rubberisation, and steps to restructure the price stabilization fund so as to make it more beneficial to the growers.
Rubber Board chairman, Sheela Thomas, who presided over the meeting, informed the members that the sentiments expressed by them would be brought to the notice of the Central Government and the board would spare no efforts to take the maximum possible measures within its jurisdiction, in this regard.
Germany: Some Malaysian Innovations Showcased At Medica Dusseldorf Saw Good Buyer Response
Even though the range of medical and healthcare products from Malaysia showcased at the four-day Medica show here have been asymmetrically rubber-based, there were some interesting and eye-catching innovations which fetched good response from potential buyers.
Indeed, these and other future innovations are capable of catapulting Malaysia into the big league of global suppliers of medical and healthcare products.
However, a pre-requisite for achieving this big league status would be that the innovations conceived and created by small companies and innovators are profiled abroad by means of smart marketing and promotional tools through Malaysia's nodal trade promotion agency, Malaysia External Trade Development Corporation (Matrade), which has offices in the leading markets of the world.
Left on their own, the innovators, particularly the small companies with limited resources and means, will probably continue to tap in the dark and not fully realise the full export potential of their innovations.
They would also need a guiding hand, given the fact that the global markets are characterised by cut-throat competition.
29 NOV 2013
Germany: Some Malaysian Innovations Showcased At Medica Dusseldorf Saw Good Buyer Response
Even though the range of medical and healthcare products from Malaysia showcased at the four-day Medica show here have been asymmetrically rubber-based, there were some interesting and eye-catching innovations which fetched good response from potential buyers.
Indeed, these and other future innovations are capable of catapulting Malaysia into the big league of global suppliers of medical and healthcare products.
However, a pre-requisite for achieving this big league status would be that the innovations conceived and created by small companies and innovators are profiled abroad by means of smart marketing and promotional tools through Malaysia's nodal trade promotion agency, Malaysia External Trade Development Corporation (Matrade), which has offices in the leading markets of the world.
Left on their own, the innovators, particularly the small companies with limited resources and means, will probably continue to tap in the dark and not fully realise the full export potential of their innovations.
They would also need a guiding hand, given the fact that the global markets are characterised by cut-throat competition.
Ukraine Plans Overhaul of Medical Device Regulatory System
Regulators in Ukraine will implement significant reforms to the country’s medical device registration system in early 2014 in order to better align market authorization requirements with those of the European Union, Emergo Group has learned.
The new system will utilize national conformity assessments similar to those used by EU regulators, and also introduces the following requirements for Ukrainian medical device registrations:
Foreign registrants must appoint Authorized Representatives based in Ukraine
Expanded list of documentation and sample submissions required for registrations
Manufacturing site inspections for Classes I, IIa, IIb and III
Special symbols of national conformity will be required for medical devices imported into Ukraine on or after 7 January 2014
National conformity certifications valid for five years
Ukrainian officials plan a transition period for manufacturers that have already obtained market authorization; authorizations that are currently valid will remain so either for the next three years or until their expiration dates, whichever come sooner.
Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are planned for devices already approved or cleared for sale in major markets such as Europe or the US. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.
Application fees will likely increase once the new market authorization system is in place, but by how much remains unclear. We will provide more details as we get them.
22 NOV 2013
Ukraine Plans Overhaul of Medical Device Regulatory System
Regulators in Ukraine will implement significant reforms to the country’s medical device registration system in early 2014 in order to better align market authorization requirements with those of the European Union, Emergo Group has learned.
The new system will utilize national conformity assessments similar to those used by EU regulators, and also introduces the following requirements for Ukrainian medical device registrations:
Foreign registrants must appoint Authorized Representatives based in Ukraine
Expanded list of documentation and sample submissions required for registrations
Manufacturing site inspections for Classes I, IIa, IIb and III
Special symbols of national conformity will be required for medical devices imported into Ukraine on or after 7 January 2014
National conformity certifications valid for five years
Ukrainian officials plan a transition period for manufacturers that have already obtained market authorization; authorizations that are currently valid will remain so either for the next three years or until their expiration dates, whichever come sooner.
Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are planned for devices already approved or cleared for sale in major markets such as Europe or the US. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.
Application fees will likely increase once the new market authorization system is in place, but by how much remains unclear. We will provide more details as we get them.
Vietnam Cuts Rubber Export Tariffs
On November 11, Vietnam's Ministry of Finance (MOF) issued a circular cutting the export tax rates on both natural and synthetic rubber exports, with effect from December 26, 2013. According to the circular, the export tariff on all rubber exports will be fixed at 1 percent. This means that the tax on synthetic rubber exports is being reduced from 5 percent to 1 percent, while the tax on exports of natural rubber will also be 1 percent, after being 3 percent previously.
22 NOV 2013
Vietnam Cuts Rubber Export Tariffs
On November 11, Vietnam's Ministry of Finance (MOF) issued a circular cutting the export tax rates on both natural and synthetic rubber exports, with effect from December 26, 2013. According to the circular, the export tariff on all rubber exports will be fixed at 1 percent. This means that the tax on synthetic rubber exports is being reduced from 5 percent to 1 percent, while the tax on exports of natural rubber will also be 1 percent, after being 3 percent previously.
Thailand: Exports 'ready to rebound'
Key markets expected to drive growth of 5%. The government expects exports to grow by about 5% next year but the expansion may fall to only 3% if political rallies turn violent. Deputy Prime Minister and Commerce Minister Niwatthamrong Bunsongphaisan admitted yesterday that the country should end up this year with export growth of only 1% to US$231.57 billion. That is far below the ministry's original forecast of 7-8% growth.
15 NOV 2013
Thailand: Exports 'ready to rebound'
Key markets expected to drive growth of 5%. The government expects exports to grow by about 5% next year but the expansion may fall to only 3% if political rallies turn violent. Deputy Prime Minister and Commerce Minister Niwatthamrong Bunsongphaisan admitted yesterday that the country should end up this year with export growth of only 1% to US$231.57 billion. That is far below the ministry's original forecast of 7-8% growth.
Korea:
European automobile industry organizations demanded to the Korean government that non-tariff barriers be removed from the nation's car market. The European Automobile Manufacturers' Association (ACEA), European Association of Automotive Suppliers (CLEPA), and European Tyre & Rubber Manufacturers' Association (ETRMA) released a joint statement, "Ahead of the EU-South Korean summit meeting, we at the European automobile industry call for more proactive measures to bring down trade barriers in Korea."
15 NOV 2013
Korea:
European automobile industry organizations demanded to the Korean government that non-tariff barriers be removed from the nation's car market. The European Automobile Manufacturers' Association (ACEA), European Association of Automotive Suppliers (CLEPA), and European Tyre & Rubber Manufacturers' Association (ETRMA) released a joint statement, "Ahead of the EU-South Korean summit meeting, we at the European automobile industry call for more proactive measures to bring down trade barriers in Korea."
India: Rubber exports slide 59% to 480 tonnes in Oct
Natural rubber exports fell by 59 per cent to 480 tonnes in October this year due to fall in domestic production. Exports of rubber in October last year stood at 1,145 tonnes, according to Rubber Board data.
Total exports of rubber during April-October period in current year has fallen by 54 per cent to 3,975 tonnes against 8,611 tonnes in the same period a year ago.
08 NOV 2013
India: Rubber exports slide 59% to 480 tonnes in Oct
Natural rubber exports fell by 59 per cent to 480 tonnes in October this year due to fall in domestic production. Exports of rubber in October last year stood at 1,145 tonnes, according to Rubber Board data.
Total exports of rubber during April-October period in current year has fallen by 54 per cent to 3,975 tonnes against 8,611 tonnes in the same period a year ago.
World: 11 countries to attend world rubber conference in Sri Lanka
China will be among the 11 countries that will attend a crucial rubber conference in Sri Lanka this week, which will decide the future for 92 percent of natural rubber suppliers in the world, an official statement said here on Monday.
The sixth Annual Rubber Conference of the Association of Natural Rubber Producing Countries (ANRPC) will open on Tuesday, 8th October in Sri Lanka under the patronage of Economic Development Minister Basil Rajapaksa.
The ANRPC, an inter-governmental organization comprises of 11 countries -- Cambodia, China, India, Indonesia, Malaysia, Papua New Guinea, Philippines, Singapore, Sri Lanka, Thailand and Vietnam.
These 11 countries account for about 92 percent of the global production of natural rubber.
The annual event organized by the government in collaboration with the Ministry of Plantation Industries will be held from Oct. 8 to Oct. 13 in Colombo.
Along with the Annual Rubber Conference, the General Assembly and the committee meetings of the ANRPC will also be held in Sri Lanka during the same time.
"Around 200 private and public sector representatives from Sri Lanka will participate in this annual conference," the statement added.
The conference with the theme "Sustainable NR Economy: Where Do We Stand?" will provide an international meeting point and an ideal platform for meaningful interactions and networking among rubber industry players, policy makers, researchers, and commodity analysts across countries, organizers say.
The conference will include presentations on trends in global Natural Rubber demand, the outlook for physical rubber trading in China and the outlook for the Natural Rubber future markets.
11 OCT 2013
World: 11 countries to attend world rubber conference in Sri Lanka
China will be among the 11 countries that will attend a crucial rubber conference in Sri Lanka this week, which will decide the future for 92 percent of natural rubber suppliers in the world, an official statement said here on Monday.
The sixth Annual Rubber Conference of the Association of Natural Rubber Producing Countries (ANRPC) will open on Tuesday, 8th October in Sri Lanka under the patronage of Economic Development Minister Basil Rajapaksa.
The ANRPC, an inter-governmental organization comprises of 11 countries -- Cambodia, China, India, Indonesia, Malaysia, Papua New Guinea, Philippines, Singapore, Sri Lanka, Thailand and Vietnam.
These 11 countries account for about 92 percent of the global production of natural rubber.
The annual event organized by the government in collaboration with the Ministry of Plantation Industries will be held from Oct. 8 to Oct. 13 in Colombo.
Along with the Annual Rubber Conference, the General Assembly and the committee meetings of the ANRPC will also be held in Sri Lanka during the same time.
"Around 200 private and public sector representatives from Sri Lanka will participate in this annual conference," the statement added.
The conference with the theme "Sustainable NR Economy: Where Do We Stand?" will provide an international meeting point and an ideal platform for meaningful interactions and networking among rubber industry players, policy makers, researchers, and commodity analysts across countries, organizers say.
The conference will include presentations on trends in global Natural Rubber demand, the outlook for physical rubber trading in China and the outlook for the Natural Rubber future markets.
The United States: FDA finalizes new system to identify medical devices
The U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
24 SEP 2013
The United States: FDA finalizes new system to identify medical devices
The U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
The Russian Federation: Russian Regulators Push Back Deadline for Medical Device Registration Reauthorizations
Russian medical device regulators have decided to extend their deadline for requiring medical device manufacturers to obtain replacement registration certifications (links to webpage in Russian) from January 2014 to January 2017.
At a July 15 meeting of Russian medical device market regulator Roszdravnadzor and the Russian Ministry of Health, officials agreed to propose amending Government Decision number 1416 in order to allow the deadline extension as well as make registration requirements for low-risk medical devices less complex.
07 AUG 2013
The Russian Federation: Russian Regulators Push Back Deadline for Medical Device Registration Reauthorizations
Russian medical device regulators have decided to extend their deadline for requiring medical device manufacturers to obtain replacement registration certifications (links to webpage in Russian) from January 2014 to January 2017.
At a July 15 meeting of Russian medical device market regulator Roszdravnadzor and the Russian Ministry of Health, officials agreed to propose amending Government Decision number 1416 in order to allow the deadline extension as well as make registration requirements for low-risk medical devices less complex.
Philippine agencies to form rubber industry cluster teams
THE DEPARTMENT of Agriculture (DA) and Department of Trade and Industry (DTI) are forming regional and provincial rubber industry cluster teams in MIMAROPA region (which includes the provinces of Mindoro, Marinduque, Romblon and Palawan), Philippines.
The move is part of efforts in uplifting the rubber industry in the country.
MIMAROPA’s potential for rubber has been identified, having vast tracts of land ideal for rubber plantation.
The high demand for rubber in the global and domestic markets pushes the country to develop the rubber infustry further. Sitti Amina Jain, DTI assistant regional director and national rubber industry cluster manager, said it is important for the country to expand rubber production to meet the market demands, likewise to take advantage increasing demands from companies such as the Yokohama Tire Philippines, which is expanding its tyre production to 50,000 tyres a day by 2017.
Currently, YTP produces 21,000 tyres a day and obtains 4% of its rubber requirements from the country.
In 2012, the Philippines produced 442,990 metric tonnes of rubber, according to the Bureau of Agriculture data.
02 AUG 2013
Philippine agencies to form rubber industry cluster teams
THE DEPARTMENT of Agriculture (DA) and Department of Trade and Industry (DTI) are forming regional and provincial rubber industry cluster teams in MIMAROPA region (which includes the provinces of Mindoro, Marinduque, Romblon and Palawan), Philippines.
The move is part of efforts in uplifting the rubber industry in the country.
MIMAROPA’s potential for rubber has been identified, having vast tracts of land ideal for rubber plantation.
The high demand for rubber in the global and domestic markets pushes the country to develop the rubber infustry further. Sitti Amina Jain, DTI assistant regional director and national rubber industry cluster manager, said it is important for the country to expand rubber production to meet the market demands, likewise to take advantage increasing demands from companies such as the Yokohama Tire Philippines, which is expanding its tyre production to 50,000 tyres a day by 2017.
Currently, YTP produces 21,000 tyres a day and obtains 4% of its rubber requirements from the country.
In 2012, the Philippines produced 442,990 metric tonnes of rubber, according to the Bureau of Agriculture data.
Brazil: ANVISA Sets Performance Targets for Next 12 Months
Brazilian medical device market regulator ANVISA has set institutional performance targets through June 30, 2014 under Ordinance No. 1.058.
Medical device registration in Brazil has proven a complicated and lengthy endeavor for some foreign manufacturers following the market’s rapid growth. If ANVISA can meet these performance targets over the next 12 months, the regulator will have added some welcome transparency and expediency to the Brazilian registration process.
26 JUL 2013
Brazil: ANVISA Sets Performance Targets for Next 12 Months
Brazilian medical device market regulator ANVISA has set institutional performance targets through June 30, 2014 under Ordinance No. 1.058.
Medical device registration in Brazil has proven a complicated and lengthy endeavor for some foreign manufacturers following the market’s rapid growth. If ANVISA can meet these performance targets over the next 12 months, the regulator will have added some welcome transparency and expediency to the Brazilian registration process.
Canada: Medical Device Spending not a Major Factor in Canadian Healthcare Costs
A recent Canadian Health Policy Institute study of medical device and healthcare costs in 66 countries has found that device spending has had an insignificant effect on overall healthcare expenditures in Canada between 2006 and 2011.
Researchers found that 55 countries spent more on medical devices per capita than Canada between 2006 and 2011, and that 33 countries spent more than Canada on medical devices as a percentage of GDP per capita.
Within Canada, medical device spending totaled less than four percent of total healthcare spending per capita over the same time period. Over the entire course of the study’s five-year timeframe, Canada ranked lower than all other top 25 Organization for Economic Cooperation and Development (OECD) countries in terms of medical device spending per capita, medical device spending as a percentage of total healthcare spending, and device spending as a percentage of GDP per capita.
12 JUL 2013
Canada: Medical Device Spending not a Major Factor in Canadian Healthcare Costs
A recent Canadian Health Policy Institute study of medical device and healthcare costs in 66 countries has found that device spending has had an insignificant effect on overall healthcare expenditures in Canada between 2006 and 2011.
Researchers found that 55 countries spent more on medical devices per capita than Canada between 2006 and 2011, and that 33 countries spent more than Canada on medical devices as a percentage of GDP per capita.
Within Canada, medical device spending totaled less than four percent of total healthcare spending per capita over the same time period. Over the entire course of the study’s five-year timeframe, Canada ranked lower than all other top 25 Organization for Economic Cooperation and Development (OECD) countries in terms of medical device spending per capita, medical device spending as a percentage of total healthcare spending, and device spending as a percentage of GDP per capita.
Middle East: Middle East Hospital Building Spree Means Boost in Future Demand for Medical Devices
Massive healthcare facility construction projects across the Arabian Peninsula suggest a significant boost in near-term regional demand for medical devices and technology, and a major opportunity for foreign manufacturers seeking new markets.
According to ConstructionWeekOnline.com, the Kingdom of Saudi Arabia (KSA) and neighboring countries have embarked on multi-billion-dollar hospital and research facility building projects as overall healthcare spending in the Middle East increases.
The largest such project, the King Abdullah Bin Abdulaziz Project for the Development of Security Forces Medical Complexes in the KSA, will cost $6.7 billion and should be completed in 2014. A $1.2 billion, 1500-bed healthcare facility, King Abdullah Medical City, is also under construction in the KSA.
14 JUN 2013
Middle East: Middle East Hospital Building Spree Means Boost in Future Demand for Medical Devices
Massive healthcare facility construction projects across the Arabian Peninsula suggest a significant boost in near-term regional demand for medical devices and technology, and a major opportunity for foreign manufacturers seeking new markets.
According to ConstructionWeekOnline.com, the Kingdom of Saudi Arabia (KSA) and neighboring countries have embarked on multi-billion-dollar hospital and research facility building projects as overall healthcare spending in the Middle East increases.
The largest such project, the King Abdullah Bin Abdulaziz Project for the Development of Security Forces Medical Complexes in the KSA, will cost $6.7 billion and should be completed in 2014. A $1.2 billion, 1500-bed healthcare facility, King Abdullah Medical City, is also under construction in the KSA.
China: State Food and Drug Administration Renames Itself China Food and Drug Administration (CFDA)
The State Food and Drug Administration (SFDA), China’s medical device market regulator, has renamed itself the China Food and Drug Administration (CFDA).
The name change reflects the elevation of the agency to ministerial level, which means CFDA now reports directly to China’s State Council and has broader authority to oversee medical device as well as food and drug sectors—potentially leading to a more streamlined and efficient registration process for medical devices in China.
17 MAY 2013
China: State Food and Drug Administration Renames Itself China Food and Drug Administration (CFDA)
The State Food and Drug Administration (SFDA), China’s medical device market regulator, has renamed itself the China Food and Drug Administration (CFDA).
The name change reflects the elevation of the agency to ministerial level, which means CFDA now reports directly to China’s State Council and has broader authority to oversee medical device as well as food and drug sectors—potentially leading to a more streamlined and efficient registration process for medical devices in China.
Brazil: Brazil GMP Requirements Streamlined
Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers have been streamlined, potentially making BGMP compliance less complicated.
A new Good Manufacturing Practices regulation, RDC 16/2013, has gone into effect in Brazil, and replaces two prior BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostic (IVD) devices. In other words, Brazilian regulators have put in place a single BGMP resolution for both medical device and IVD manufacturers; companies marketing higher-risk medical devices and IVDs in Brazil, as well as medical devices listed in Normative Instruction IN 02/11, now have only one set of BGMP requirements to meet, and may furthermore utilize a single BGMP inspection request instead of two separate ones for medical devices and IVDs. For these companies, the new regulation avoids the cost of a second BGMP inspection request.
03 MAY 2013
Brazil: Brazil GMP Requirements Streamlined
Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers have been streamlined, potentially making BGMP compliance less complicated.
A new Good Manufacturing Practices regulation, RDC 16/2013, has gone into effect in Brazil, and replaces two prior BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostic (IVD) devices. In other words, Brazilian regulators have put in place a single BGMP resolution for both medical device and IVD manufacturers; companies marketing higher-risk medical devices and IVDs in Brazil, as well as medical devices listed in Normative Instruction IN 02/11, now have only one set of BGMP requirements to meet, and may furthermore utilize a single BGMP inspection request instead of two separate ones for medical devices and IVDs. For these companies, the new regulation avoids the cost of a second BGMP inspection request.
Europe: Recommendations for European UDI System Released
European Commisioners have published recommendations for an EU-wide Unique Device Identification (UDI) system in the Official Journal of the European Union.
It is anticipated that the eventual EU UDI system as well as the US Food and Drug Administration’s soon-to-be-released UDI system will resemble the International Medical Device Regulator Forum’s (IMDRF) recommendations.
The scope of the recommendation covers medical devices, active implantable medical devices and IVDs.
European Commissioners recommend developing a single UDI system harmonized across the EU, and that any member state pursuing its own UDI system builds in compatibility to the eventual Union-wide system. Furthermore, any member state developing its own UDI system should follow a risk-based approach corresponding to device classification, and implement the system in phases, starting with highest-risk products.
19 APR 2013
Europe: Recommendations for European UDI System Released
European Commisioners have published recommendations for an EU-wide Unique Device Identification (UDI) system in the Official Journal of the European Union.
It is anticipated that the eventual EU UDI system as well as the US Food and Drug Administration’s soon-to-be-released UDI system will resemble the International Medical Device Regulator Forum’s (IMDRF) recommendations.
The scope of the recommendation covers medical devices, active implantable medical devices and IVDs.
European Commissioners recommend developing a single UDI system harmonized across the EU, and that any member state pursuing its own UDI system builds in compatibility to the eventual Union-wide system. Furthermore, any member state developing its own UDI system should follow a risk-based approach corresponding to device classification, and implement the system in phases, starting with highest-risk products.
South Korea: South Korean Medical Device Approvals Up 7% in 2012
South Korea’s Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration, has released new data showing that medical device approvals increased by nearly seven percent from 2011 to 2012.
The MFDS attributes the increase to growing demands for devices among an aging South Korean population.
The increase in approvals falls in line with overall trends in Korean healthcare spending, which grew by 47% between 2005 and 2010. South Korea is now the fourth largest healthcare market in the Asia-Pacific region, following Japan, China and Australia.
19 APR 2013
South Korea: South Korean Medical Device Approvals Up 7% in 2012
South Korea’s Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration, has released new data showing that medical device approvals increased by nearly seven percent from 2011 to 2012.
The MFDS attributes the increase to growing demands for devices among an aging South Korean population.
The increase in approvals falls in line with overall trends in Korean healthcare spending, which grew by 47% between 2005 and 2010. South Korea is now the fourth largest healthcare market in the Asia-Pacific region, following Japan, China and Australia.
Brazil: Brazilian Regulator Considers Accepting Foreign GMP Certifications
Brazil’s medical device regulatory agency ANVISA may move to recognize international Good Manufacturing Practice certifications (in Portuguese) from medical device manufacturers seeking commercialization in the country.
By accepting audits and inspections carried out by international agencies and accreditation bodies, ANVISA could potentially reduce its annual Brazilian Good Manufacturing Practice (BGMP) overseas inspection workload by 70%, and foreign companies would face a less onerous registration process in Brazil.
05 APR 2013
Brazil: Brazilian Regulator Considers Accepting Foreign GMP Certifications
Brazil’s medical device regulatory agency ANVISA may move to recognize international Good Manufacturing Practice certifications (in Portuguese) from medical device manufacturers seeking commercialization in the country.
By accepting audits and inspections carried out by international agencies and accreditation bodies, ANVISA could potentially reduce its annual Brazilian Good Manufacturing Practice (BGMP) overseas inspection workload by 70%, and foreign companies would face a less onerous registration process in Brazil.
The United States: Six Mistakes Sure to Delay Your FDA 510k Submission
In July 2011, the US Food and Drug Administration conducted an analysis of its 510(k) data to determine the causes of increasing medical device clearance review times. In the study, the FDA identified six deficiency categories of what it considers "quality" issues with 510(k) submissions. Those deficiencies are listed in the article. If your 510(k) application contains any one of these issues, your medical device 510(k) review will likely be delayed in being cleared by FDA.
08 MAR 2013
The United States: Six Mistakes Sure to Delay Your FDA 510k Submission
In July 2011, the US Food and Drug Administration conducted an analysis of its 510(k) data to determine the causes of increasing medical device clearance review times. In the study, the FDA identified six deficiency categories of what it considers "quality" issues with 510(k) submissions. Those deficiencies are listed in the article. If your 510(k) application contains any one of these issues, your medical device 510(k) review will likely be delayed in being cleared by FDA.
The United States: New US Medical Device Tax on Manufacturers and Importers
The US Patient Protection and Affordable Care Act (PPACA) healthcare reform legislation passed in 2010 includes a 2.3% excise tax applicable to manufacturers and importers of taxable medical devices sold or imported in/to the United States. The industry has known about the Medical Device Excise Tax (MDET) since the passage of the PPACA, but now it is crunch time for manufacturers and importers to ensure compliance with the new tax requirements.
The US Internal Revenue Service (IRS) issued final regulations regarding the MDET in late 2012, and also issued Notice 2012-77 to further address compliance issues. The IRS has also posted a web page to answer common questions about the MDET.
22 FEB 2013
The United States: New US Medical Device Tax on Manufacturers and Importers
The US Patient Protection and Affordable Care Act (PPACA) healthcare reform legislation passed in 2010 includes a 2.3% excise tax applicable to manufacturers and importers of taxable medical devices sold or imported in/to the United States. The industry has known about the Medical Device Excise Tax (MDET) since the passage of the PPACA, but now it is crunch time for manufacturers and importers to ensure compliance with the new tax requirements.
The US Internal Revenue Service (IRS) issued final regulations regarding the MDET in late 2012, and also issued Notice 2012-77 to further address compliance issues. The IRS has also posted a web page to answer common questions about the MDET.
Russian Medical Device Regulatory Changes Emerge
Revised regulations (in Russian only) for the Russian medical device market have been in effect since January 1, 2013, and Emergo Group has now learned more details of these changes, although some specifics of the new rules are still needed. All medical device registrations submitted to Russian medical device market regulator Roszdravnadzor after January 1, 2013 will fall under the new requirements; applicants seeking registration under the previous regulations must provide a written statement to Roszdravnadzor as soon as possible.
25 JAN 2013
Russian Medical Device Regulatory Changes Emerge
Revised regulations (in Russian only) for the Russian medical device market have been in effect since January 1, 2013, and Emergo Group has now learned more details of these changes, although some specifics of the new rules are still needed. All medical device registrations submitted to Russian medical device market regulator Roszdravnadzor after January 1, 2013 will fall under the new requirements; applicants seeking registration under the previous regulations must provide a written statement to Roszdravnadzor as soon as possible.
Malaysia: Intra-regional trade boosts exports
PETALING JAYA: Last November's export figures for the country provided cheer by registering an unexpected increase, rising 3.3% year-on-year (y-o-y) to RM58.67bil, driven by shipments of manufactured goods to Asean and China. Economists had expected a median 2.3% gain in exports after the 3.2% y-o-y decline in October.
According to the Statistics Department, exports of manufactured goods increased 5.2% to RM39.36bil due mainly to higher exports of transport equipment, optical and scientific equipment as well as electrical and electronic products.
11 JAN 2013
Malaysia: Intra-regional trade boosts exports
PETALING JAYA: Last November's export figures for the country provided cheer by registering an unexpected increase, rising 3.3% year-on-year (y-o-y) to RM58.67bil, driven by shipments of manufactured goods to Asean and China. Economists had expected a median 2.3% gain in exports after the 3.2% y-o-y decline in October.
According to the Statistics Department, exports of manufactured goods increased 5.2% to RM39.36bil due mainly to higher exports of transport equipment, optical and scientific equipment as well as electrical and electronic products.