FDA's latest deregulatory action comes under the authority gained through the 21st Century Cures Act of 2016. The Cures Act requires FDA to identify low-risk devices that it determines no longer require a 510(k) review to provide reasonable assurance of safety and effectiveness. Devices newly exempted from 510(k) review under the final order are still subject to other regulatory controls, such as good manufacturing practice requirements.
The medical device industry hailed President Trump's signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade. The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn't eliminate the tax or put it on hiatus once again.
Proton Holdings Bhd's (Proton) strategic alliance with Zhejiang Geely Holding Group (Geely) in 2017 has started yielding desired results for the national carmaker, in particular product improvements and sales volume. Corporate strategy and risk management senior director Yusri Yusuf said the partnership had strengthened Proton's brand in products development with better quality backed by Geely's advanced technologies.
Top Glove Corp Bhd's first quarter profits ended November 2019 rose 1.24 per cent to RM111.43 million from RM110.06 million a year ago, thanks to better glove exports. This pushed earnings per share slightly higher than 4.36 sen from 4.31 sen it was previously. In its filing to the stock exchange today, Top Glove said revenue for the quarter eased to RM1.21 billion from RM1.26 billion, previously.
Earlier this month, the International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version. The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms "benefit", "reasonably foreseeable misuse" and "state of the art".
Notified bodies in Europe are struggling to keep pace with an increasingly heavy workload ahead of introduction of some of the most significant changes in a generation to the regulation of medical devices in Europe. An overhaul of European Union medical device regulation is slated to come into play May 26, 2020. MDR has reclassified many devices to a higher risk level and, as a result, a large number will require notified body review - including those that used to be able to self-certify under the older EU directive.
On Monday, Gas Malaysia Bhd announced the government had approved for the group to effect the natural gas selling price for the distribution segment for Jan 1, 2020 to Dec 31, 2021. As the gas selling price will now be revised annually instead of semi-annually, allowing manufacturers to better manage costs. Take note that natural gas accounts for roughly 10% of glove manufacturers' total costs, the rubber sector's profit would increase 0.9% per year until the average selling price is lowered 0.3% to neutralise the impact of a 2.9% cost-benefit.
Implementation of sweeping new rules overhauling how medical devices are regulated in the European Union is just six months away. Industry has been arguing for more than a year that the system isn't yet ready to handle the onslaught of devices that must be reviewed under the Medical Device Regulation, particularly when the number of notified bodies designated to certify them is much lower than the 20 that the EC expected by year's end, with only seven available so far. The regulation is set to take effect May 2020.
The soon-to-be launched National Automotive Policy (NAP) 2019 will open up opportunities for local players to further explore cooperation with the South Korean automotive sector. Prime Minister Tun Dr Mahathir Mohamad said he was impressed with the advancements made by the South Korean automotive sector and would like it to consider investing more in Malaysia.
The rubber industry is expected to contribute RM41 billion in 2020 from RM40 billion estimated for this year, driven mainly by the downstream sector including rubber glove, according to Minister of Primary Industries Teresa Kok. She said it was in line with rubber glove industry projection that export revenue would likely hit RM20.68 billion in 2020 from the RM18.2 billion expected in 2019.
European regulators have proposed extending Medical Devices Regulation (MDR) compliance deadlines for devices previously considered Class I by four years, to May 2024. The European Union has published a second batch of draft corrections (the second corrigendum) to the text of the MDR; the most significant of these corrections targets Article 120(3) of the Regulation addressing devices that were considered Class I under the Medical Devices Directive), but will have to partner with Notified Bodies to undergo conformity assessment for CE Marking under the MDR, resulting in upclassification of these products under the MDR.
Top Glove Corporation Bhd (Top Glove) is expected to record improvements in its performance starting from the fourth quarter of 2019 (4Q19) onwards. "We believe that Malaysian manufacturers will start gaining market share in the coming months as the 15 per cent tariff on Chinese gloves was implemented since September 2019.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).
Just because the European Commission extended for two years the effective date of the European Database on Medical Devices doesn't mean manufacturers should sit back and wait. The database, known as Eudamed, is meant to be a collection of information on devices sold in the European Union that will be used to monitor their safety and performance. The data will be accessible by regulators, notified bodies, scientists and the public.
Device certification to meet underserviced Canadian market needs for long-term, remote ECG recording and ECG management software solutions. Toronto, Ontario--(Newsfile Corp. - October 28, 2019) - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global provider of consumer heart monitoring and electrocardiogram ("ECG") acquisition and management software solutions, today announced it has entered into an exclusive sales and marketing agreement for the GEMâ„¢ Sirona with California-based Datrix LLC ("Datrix").
Hartalega Holdings Bhd's net profit eased 13.6 per cent in the second quarter (Q2) ended September 30, 2019 to RM103.87 million from RM120.22 million a year ago. In a filing to Bursa Malaysia, the nitrile glove manufacturer said this was mainly due to lower average selling price and higher packaging and natural gas cost. Its revenue in the same quarter eased 0.7 per cent to RM709.42 million from RM714.24 million due to to lower average selling price.
NAFDAC refers to the National Agency for Food and Drug Administration and Control which is the government regulatory agency charged with the mandate of regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of certain products referred to as "Regulated Products".
The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for medical devices not yet registered in the country. SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in emergency cases, or when more conventional therapies have proven unsuccessful.
State Rural Development Minister Datuk Ewon Benedick said the pilot project to build a 2km-rubberised road using bitumen-rubber technology in Kadamaian is currently in the information gathering process. He said this is because road construction using such technology has never been implemented in Sabah and Sarawak before.
We are positive about Hartalega Holdings Bhd's growth going forward, underpinned by an uptick in demand, cost-saving initiatives and potential margin expansion from operating efficiency and better economies of scale at Plant 5. Due to the impact of the ongoing US-China trade war whereby effective Sept 1, a 15% tariff is imposed on Chinese-made medical and vinyl gloves, local rubber glove players expect to see an uptick in demand for gloves, of which the positive impact is expected to be felt from the December-ending quarter.
Brazilian medical device market regulator ANVISA has issued two new consultations proposing changes to longstanding regulations of medical devices and IVD products. The regulator will accept comments on the new consultations (link in Portuguese) for a 60-day period before moving ahead with proposed changes.
Malaysia must take advantage of the positive trend in the global market for medical devices industry by positioning the nation as a preferred destination among foreign investors. Prime Minister Tun Dr Mahathir Mohamad said Malaysia could strengthen its global market competitiveness by providing a conducive business environment for multinational companies.
Consumers are becoming increasingly tech-centred. While energy efficiency and occupant safety will always take primacy, the application of connectivity is also significant. Within the topic of innovative enhancements, another pertinent area to note is autonomous technology which will be a key inflection point for the industry. We believe the success of the local industry hinges on new technology investments.
Malaysia's government will likely present an expanded Budget on Friday (Oct 11) to temper a weak economic outlook, as it grapples with global recession fears, the protracted US-China trade war and a large debt pile left behind by its predecessors.
The Human Resource Ministry will extend a helping hand to rubber glove employers in carrying out a comprehensive social compliance audit in line with the international standards before it comes into force in 2021, said its Minister M. Kulasegaran. He said following the United States (US) ban on the import of disposable rubber gloves of Malaysia's WRP Asia Pacific Sdn Bhd for suspected use of forced labour, efforts to comply with the international laws must start immediately.
The US has not banned Malaysian-made rubber gloves, the Malaysian Rubber Export Promotion Council (MREPC) has clarified. In a statement, MREPC Chairman Chik Chan Chee said reports stating that the US Customs and Border Protection (CBP) has banned the import of rubber gloves are false. The ban imposed is only on a specific company, and rubber gloves manufactured by other companies remain unaffected.
The Malaysian Rubber Export Promotion Council (MREPC) is rolling out a new incentive to encourage companies in the rubber product industry to undergo social compliance audits to meet social and ethical responsibilities. MREPC chairman Chik Chan Chee said that audits by independent auditors could be costly as some companies have to undergo multiple audits to meet requirements determined by different buyers.
It's safe to say very few commentators, within or outside the medical device industry, are actively championing the prospect of a no-deal Brexit. The EU is the UK's biggest trading partner for health technologies, with around Â£2bn worth of goods exported into Europe each year and Â£3.3bn in European medical products imported into the country.
The total industry volume (TIV) grew 0.5% month-on-month (m-o-m) to 51,148 units in August due to improving demand for passenger cars, multipurpose vehicles and window vans. Passenger vehicles registered a 1.3% m-o-m volume growth, while commercial vehicle sales fell 7.3% m-o-m. The Malaysian Automotive Association (MAA) expects a flattish September TIV m-o-m due to the number of public holidays shortening the number of working days.
Affin Hwang Capital (Affin Hwang), a Malaysian-based investment banking group, has suggested that the weak demand for gloves from Malaysia was because of increased Chinese glove imports into the US, and highlighted a few challenges that has limited local glove manufacturers' ability to raise their selling price, namely the value perception between latex and nitrile gloves, overcapacity and the time lag in price-setting.
The delays in introducing the revised National Automotive Policy (NAP) have reached to a point that not many, including some industry players, are even enthusiastic about it anymore. Initially, it was supposed to be unveiled in the first quarter of 2019 (1Q19). It did not happen. As we now are coming to the end of 3Q19, nothing is yet announced on the new NAP.
While local laws of Singapore, Malaysia and Indonesia have fully complied with the ASEAN Medical Device Directive (AMDD), it is encouraging to see more developments of various Member States in ASEAN this year. From the report of the 8th ASEAN Medical Device Committee (AMDC) Meeting and Related Activities -Industry Training Sessions and Public-Private Forum which took place in the Philippines this month, the Philippines will be launching a pilot study (Phase 0) in August 2019.
Australia's Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.
Malaysian rubber glove manufacturers are set to reap the benefits if the US goes ahead and slaps a fresh round of tariffs on Chinese goods on Sept 1 as American companies and consumers seek cheaper alternatives. Medical gloves are on the target list of products that will be subject to a 10% tariff. A 25% tariff had been imposed on non-medical gloves since May.
Following UK Prime Minister Boris Johnson's recent end-run around the British Parliament to truncate debate on avoiding a no-deal Brexit, the likelihood that the UK will withdraw from the European Union without significant economic safeguards in place on October 31, 2019 appears greater than ever.
Supermax Corporation Bhd's fourth quarter net profit surged 84% to RM9.84 million from RM5.34 million a year ago, thanks to higher sales. Earnings per share for the quarter ended June 30, 2018 increased to 1.49 sen from 0.8 sen previously, the glove maker said in a stock exchange filing. Quarterly revenue rose 5.3% to RM329.46 million from RM312.91 million a year ago, on improved sales of its natural and nitrile rubber gloves.
Kossan Rubber Industries Bhd's (Kossan Rubber) net profit increased 28.64 per cent to RM55.88 million in the second-quarter (Q2) ended June 30, 2019, from RM43.44 million previously. In an exchange filing today, the glove manufacturer said the higher profit was contributed by increased sales volume for glove products and production output, supported by manufacturing efficiency and effective cost controls.
TOP GLOVE Corp Bhd is expecting double-digit growth in sales for its financial year 2020 (FY20) and better performance compared to the current financial year, based on the glove industry demand which grew at 10% annually and has a potential to expand further. Executive chairman Tan Sri Dr Lim Wee Chai (picture) said FY20 is seen to provide a more positive outlook for the sale of its products, which further strengthens the group's position as the world's leading rubber glove manufacturer.
IMQ is the fourth Notified Body (NB) to be designated, after BSI Assurance UK Ltd, TUV SUD Product Service GmbH and DEKRA Certification GmbH. Given Brexit-related uncertainties in the UK and their potential impact for BSI, IMQ is for now the third EU-based option for companies who want to certify under the MDR.
The local rubber industry is expected to maintain its double-digit exports growth momentum this year despite challenges arising from the ongoing trade war between the US and China. Major corporations in the rubber industry which comprise the world's top four glovemakers - Hartalega Holdings Bhd, Top Glove Corp Bhd, Kossan Rubber Industries Bhd and Supermax Corp Bhd - expect annual growth to hit about 10% in 2019 from last year's total exports worth RM23.7 billion.
DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU) 2019/745 (MDR). DEKRA's designation is now published in Nando. DEKRA is the third Notified Body (NB) to be designated, after BSI Assurance UK Ltd and TUV SUD Product Service GmbH. BSI is currently not recommended as an NB because of the very high risk of the UK leaving the EU under a no-deal Brexit scenario on October 31st, so DEKRA is for now the second option for companies who want to certify under the MDR.
Primary Industries Minister Teresa Kok is leading a Palm Oil and Rubber Economic and Investment Mission to India beginning yesterday to strengthen trade relations between New Delhi and Putrajaya. The five-day mission is also aimed to address issues related to trade as well as exploring market and investment opportunities, particularly in palm oil and rubber.
The European Medicines Agency has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called drug-device combinations or DDCs). Reporting on the news, the ECA Academy explained: "This draft guideline also deals with the implementation of the Medical Devices Regulation - and, in particular, with Article 117 of the MDR.
US Food and Drug Administration medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications will increase by about six percent for the agency's 2020 fiscal year. FDA's 2020 user fee schedule takes effect October 1, 2019, and entails six-percent increases for both standard and small-business rates. The agency's 2020 fiscal year increases are slightly higher than for 2019, which saw four-percent increases for most user fees.
Supermax announced to Bursa Malaysia that it has acquired a freehold land with industrial premises at Kapar, Klang for RM65 million cash. Land size is 65,550 sqm (or 706,000 sq ft). The seller is Leader Cable Industry, a wholly-owned subsidiary of Sarawak Cable. We gather that the premise has already obtained a certificate of fitness and other local authorities' licences. The premise is also connected to water and electricity supplies.
Australia's Therapeutic Goods Administration (TGA) has implemented final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors. The TGA guidance applies to software as a medical device (SaMD) as well as medical devices and IVDs incorporating components that may be vulnerable to cyber threats.
The gas tariff hike of 5.3% is expected to only minimally impact glove manufacturers' earnings in the third quarter, said CGS-CIMB. The additional cost from the tariff hikes is expected to be manageable, as gas makes up only 8% to 10% of the total cost for glove makers. In the event that glove manufacturers fully absorb the additional cost, CGS-CIMB estimates a net increase of 0.4% to 0.5% in total costs. This will result in a minimally negative impact to the sector's earnings by 0.4% to 1.2% for 2019 to 2021.
The European Commission has published new guidance clarifying manufacturers' obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). The guidance augments issues covered by MEDDEV 2.12-1 rev. 8, including Manufacturer's Incident Reports (MIR), and field safety actions and notices, and device-specific vigilance reporting recommendations.
The negatives of the rubber glove manufacturing industry have been largely priced in and glove stocks are now trading above their respective mean, indicating undemanding valuations. Over the recent quarter, the rubber glove industry has weathered the worst, given the sharp deterioration in operational earnings per glove.
While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU's medical device directive
Top Glove Corp Bhd, which recently entered the European market, will soon venture into the United States to sell its flagship biodegradable gloves amid high demand for the green product. Executive chairman Tan Sri Lim Wee Chai said the company is identifying business partners for both the European and US markets to capitalise on the demand.
Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Subjects discussed in the meeting between ANVISA and Emergo by UL included evidence that Brazilian regulators are seeing a major increase in submissions for custom-made devices including 3D-printed medical products in recent years, prompting the need to define specific criteria for these devices including their importation and manufacturing.
Top Glove Corp Bhd recently launched its BioGreen biodegradable nitrile gloves (Powder-Free), in conjunction with World Environment Day. In a statement, Top Glove said this eco-friendly variant of disposable nitrile gloves is designed to degrade easily in anaerobic environments (where there is little to no breathable oxygen) such as in landfills. The biodegradability of the gloves is being measured using the internationally-recognised ASTM D5511 Standard Test.
Glovemaker Kossan Rubber Industries (Kossan) expects to spend close to MYR1.5 billion (US$358.8 million) on its new advanced glove manufacturing plant in Perak, Malaysia. Construction on the 824-acre (333ha) land, acquired at a bargain price of MYR82.4 million from Perak's State Development, will begin in June 2020 and is estimated to be complete by 2022.
World's third-largest glovemaker, Kossan Rubber Industries Bhd, has allocated up to RM1.5 billion in capital expenditure for the construction of its new plant in Bidor, Perak. Group MD and CEO Tan Sri Lim Kuang Sia (picture) said the land clearing process is expected to begin in September, while construction works for the new rubber glove manufacturing plant will commence in June 2020. The state-of-the-art plant is estimated to be completed in three years.
The first phase of Kedah Rubber City (KRC), encompassing 500 acres of Ladang Bukit Ketapang, will be completed by next year, said Kedah Menteri Besar Mukhriz Mahathir. Steered by the Northern Corridor Implementation Authority (NCIA), the KRC according to Mukhriz, has been conceptualised and instituted to revolutionise the nation's rubber industry.
Specialised cleanroom and healthcare gloves manufacturer, Riverstone Holdings, has reported financial results for Q1. Despite upping its revenue, the costs of extended expansion plans meant the gross profit took a hit. Driven by growing sales volume for both its healthcare and cleanroom gloves, the group's revenue rose 14.6% year-on-year to RM240.5 million (US$57.8m).
The European Medicines Agency (EMA), which oversees the European Union's pharmaceutical market, has begun rolling out guidance and clarifications regarding Medical Devices Regulation (MDR) compliance issues for manufacturers of combination products with drug and medical device components.
The Malaysian rubber glove industry is expected to be a key potential beneficiary of the US-China trade war, said CGS-CIMB. The tariff hike on glove exports from China to the US could see a shift in US glove demand to Malaysian glove manufacturers.
With the European Medical Devices Regulation (MDR) coming into force in less than one year, plus related challenges such as Brexit, Notified Body capacity and Eudamed database implementation, manufacturers of CE-Marked devices have a lot to track in order to maintain European market compliance.
Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements.
Glove maker CE Technology Bhd plans to raise RM12.48mil from its proposed listing on the Leading Entrepreneur Accelerator Platform (LEAP) Market of Bursa Securities. CE Technology, the country's second largest cleanroom gloves exporter, said on Tuesday it would place out 52 million shares or 15.02% of the companyâ€™s enlarged share capital to selected investors at an indicative price of 24 sen per share.
The Malaysian Finance Ministry, after being alerted by the Sabah Government and the Sabah Rubber Industry Board (LIGS), has announced a welfare aid totaling RM42 million for rubber smallholders in Sabah following the monsoon season. The sum will be distributed by the Chief Minister of Sabah to some 70,000 rubber smallholders who will receive RM600 each.
The British government has asked for - and the EU Member States unanimously agreed to - a further extension of the article 50 procedure, by which a Member State can leave the EU in two years' time. The previous date had been set at March 29th, then it was extended until April 12th; the new Brexit date is now set on October 31st 2019. This is a sensitive date because in this period most warehouse capacity in the UK is used for Christmas-related merchandise. It would be most inconvenient having a no-deal Brexit go into effect in that same time period.
In the last two years, the sector has become a victim of its own success. A frantic capacity expansion resulted in a mild excess supply for rubber gloves, leading to a compression of average selling prices (ASPs) and flattish or lower profits over the past two quarters. However, we take comfort that this is nothing more than just a temporary rough patch.
International Brands Gallery (IBG) is introducing their new Napure mattress model at Perfect Livin '19 home expo. LSK Mattressworld Sdn Bhd general manager Ratnadewi Bahwandi said the entry-level model named Dassel had undergone a facelift, with a sleeker and modern style.
Prime Minister Tun Dr Mahathir Mohamad reiterated today that the third national car and the automotive industry are crucial to the country. Speaking at the opening of the 2019 Malaysia Autoshow, Dr Mahathir said that in 2018, based on statistics from the Malaysia Automotive Association (MAA), Malaysia exported vehicles worth RM2 billion, while the automotive components exported amounted to RM12 billion.
The US Food and Drug Administration has published a finalized list of accessories to be designated as low-risk Class I medical devices in accordance with the FDA Reauthorization Act of 2017 (FDARA). FDA's final rule will go into effect May 13, 2019.
TOP Glove Corp Bhd, the world's largest rubber glove manufacturer, is looking to manufacture medical catheters as part of its diversification plan. Executive chairman Tan Sri Lim Wee Chai tells The Edge in an exclusive interview that the initial groundwork has already been completed.
Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders' sterilization processes constitute "significant changes" following the closure of a major sterilization facility in the US earlier in 2019.
Malaysia's economy is projected to grow between 4.7 and 4.8 per cent this year, if the conditions improve during the second half of the year, said Deputy International Trade and Industry Minister Dr Ong Kian Ming. He said the manufacturing sector would continue to drive the country's exports and economic growth, adding that the ministry would continue to spur its growth and investments.
Japan's Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants. The new fees have taken effect as of April 1, 2019 (link in Japanese).
US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues. According to a US FDA announcement, the agency acknowledges that despite current safety measures in place for certain implantable devices, "more work needs to be done" to address inflammatory reactions and other health conditions some patients experience after being implanted with these devices. FDA specifically mentions breast implants as well as metal, animal and innovative material components of devices such as metal-on-metal hip implants as warranting further assessment.
The world's largest rubber glove manufacturer Top Glove Corp Bhd is expecting about 15-20% reduction in factory workers for the financial year ending Aug 31, 2019 (FY19), on the back of greater automation and digitalisation of its production lines, said its chairman Tan Sri Dr Lim Wee Chai. Currently, Top Glove's factory workers in Malaysia amounted to 10,000 people, which comprise about 55.6% of its total workforce of 18,000 employees.
The national automotive landscape involves many areas of engineering that need to be upgraded, including adapting to new technologies, said Deputy International Trade and Industry Minister Dr Ong Kian Ming. Echoing Prime Minister Tun Dr Mahathir Mohamad's call for the industry to gain knowledge in automotive engineering technology, in relation to the third national car, Ong said there are always new technologies coming into the automotive sector.
The US Food and Drug Administration (FDA) issued final guidance on medical devices containing materials derived from animal sources on March 15, 2019. The guidance is intended to help device companies establish and document procedures that mitigate risk of infectious disease exposure through contact with devices containing animal-derived materials. It expands on recommendations in the draft document issued in 2014 and in the previous document issued in 1998.
The development of the third national car is not for the sake of adding another brand besides Proton and Perodua. The aim is for the integration of the automotive sector to make Malaysia the vendor for industry players in ASEAN. Deputy International Trade and Industry Minister Dr Ong Kian Ming said the automotive sector in Malaysia was not just about national cars and it should be viewed beyond the sectorial perspective.
The uncertainties about a "No-Deal Brexit" may distract many manufacturers from preparing adequately for the new requirements associated with the new Medical Device Regulation (MDR), including clinical data rules. The need to provide clinical data for a significantly increased number of medical devices, whether the data is collected on a predicate device, during pre-CE clinical trials or during Post Market Clinical Follow-up (PMCF) studies, will present a big challenge for most manufactures.
Malaysia's automotive industry is off on a positive start this year, led by strong numbers recorded by national carmakers. Analysts expect the industry to continue this strong momentum, underpinned by healthy demand and favourable foreign exchange (forex).
The Food and Drug Administration (FDA) plays a critical role in the oversight of many medical devices used commonly in dermatology that range from high-risk to low-risk products. Within the FDA, the Center for Devices and Radiological Health (CDRH) is the responsible Center for the regulation of medical devices.
In a month's time, Malaysia will bring its largest-ever business delegation, comprising officials from the government, corporates, SMEs, and other institutions, to participate in IESS VII, an engineering expo being organised by EEPC India, in Chennai. The objective is to explore investment opportunities and forge joint ventures in manufacturing and technology as Malaysia looks beyond traditional areas for cooperation.
The US Food and Drug Administration plans to formalize processes for managing feedback requests received from medical device companies cited for deficiencies following establishment inspections, helping firms to determine adequate responses and corrective actions. New draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form (Form 483) inspectional observations may submit requests for nonbinding feedback, as well as for how the agency reviews and answers these requests.
Share prices in the rubber gloves sector have corrected by 11.5% year to date despite being one of the best performing sectors in Malaysia for 2018. Affin Hwang Capital research maintained its overweight call on the sector although it noted potential downside risk depending on the outcome of China's environmental policy.
Malaysia's natural rubber production increased 5.4% to 54,992 tonnes in December 2018 from 52,174 tonnes in November 2018, according to the Department of Statistics. However, year-on-year comparison showed the production dropped 18%. Average price of latex concentrate declined 1% to 377.00 sen per kilogramme, whereas the average price of Standard Malaysian Rubber 20 (SMR 20) rose 1.7% to 518.18 sen per kilogramme as compared with the average prices in November 2018.
NGO Healthcare Without Harm (HCWH) Europe has published advice to help hospitals and authorities procure safer medical devices. The guidelines, published in December, are in line with the EU Directive on public procurement and the EU Medical Device regulation (MDR), which sets a concentration limit of 0.1% for hazardous substances in medical devices.
The Association of British HealthTech Industries (ABHI) has reassured its members that a UK product safety mark to replace the CE mark in the event of a no-deal Brexit will not apply to medical devices. In the UK, all medical devices are subject to EU legislation, which requires manufacturers to place CE marks on their products to show compliance to applicable standards.
Malaysia's exports grew better than expected in December, boosting the country's trade surplus as imports dipped sharply from a month earlier, government data showed on Wednesday. December's trade surplus came in at 10.4 billion ringgit, up from 7.6 billion ringgit registered a month earlier.
The Ministry of Food and Drug Safety said it would enhance drug safety management and make a new review process for advanced healthcare goods. The ministry announced its yearly administrative plan at a news conference in Osong, North Chungcheong Province, Monday.
On December 31, 2018, the Vietnamese government promulgated Decree No. 169/2018/ND-CP (Decree 169), amending Decree No. 36/2017/ND-CP (Decree 36) on medical device management. Decree 169 took immediate effect upon its issuance. The new regulations will have a great impact on the circulation of medical devices, especially foreign products, in Vietnam.
Amid the headwinds and recent sell down of rubber glove stocks, Top Glove Corp Bhd is unfazed and says it is well on track with its expansion strategy for 2019. The setback in its acquisition of surgical glove specialist Aspion Sdn Bhd according to executive chairman Tan Sri Lim Wee Chai will not put a dent on Top Glove's future acquisitions.
For the past few years Malaysia's automotive sector has proven itself to be one of Malaysia's key industries. Figures from last year reveal that the sector played a significant role in the country's economy, contributing 4.2 percent to the country's total gross domestic product (GDP). On its own, the automotive sector continues to improve, demonstrating growth in many segments within the sector.
The revised National Automotive Policy (NAP), expected to be unveiled this year, will cover the entire automotive ecosystem and include new elements of technology. Among the new elements are the next generation vehicles, mobility as a service, Industrial Revolution 4.0 and artificial intelligence.
On December 7, 2018, the U.S. Food and Drug Administration ("FDA") published a proposed rule ("Proposed Rule") that, if finalized, would clarify the de novo classification process for medical devices, including the format and contents of a de novo request and the criteria for accepting or denying a de novo request. FDA intends to "enhance regulatory clarity and predictability...provide a regulatory framework that sets clear standards, expectations and processes for de novo classification" through this proposed rulemaking.
In an industry coverage note last week, Kenanga Investment Bank Bhd said anecdotal evidence suggests the share price rally of rubber glove makers was led largely by massive price-earnings (PE) ratio expansion as earnings growth has been pedestrian over the past eight quarters. Its analysis suggests the strong surge in share prices of rubber glove stocks was mainly due to inflation in the PE multiple and not so much on earnings growth.
On January 3rd, 2019, the MHRA published guidelines for the situation of a no-deal Brexit. If no agreement is reached, the UK may decide to leave the EU without any deal. Then the UK will become, from the perspective of the EU, a "third country," Imports from third countries are captured in EU rules, but for goods moving from the EU to the UK these rules currently do not exist. The same goes for rules for non-EU manufacturers that want to place devices on the UK market. Therefore these MHRA guidelines are well appreciated, although the time for preparations is short.
Brexit-related change will define the European pharmaceutical and healthcare sector in 2019, both in terms of how drug products are regulated and how they are marketed. But, while Brexit is certain to impact the development, manufacture and sale of drugs, the ongoing lack of clarity on the future relationship between the UK and EU makes gauging the precise impact very difficult. The following predictions for 2019 are based on those certainties that are available at the time of going to press.
The government may include the end-of-life vehicle (ELV) mechanism under the next automotive policy or Malaysia Automotive Policy (MAP). According to a source close to the development, despite the Ministry of Transport's (MoT) decision to shelve ELV implementation in June last year, the government is still studying the policy and its viability in Malaysia.