Hong Seng Consolidated Bhd has today received the approval from Northern Corridor Implementation Authority (NCIA) to buy 42.49 hectares of federal land in Kedah Rubber City (KRC) for RM45.74 million. In a statement today, Hong Seng said the acquisition, via its wholly-owned Hong Seng Industries Sdn Bhd (HS Industries), was for the setting up of a nitrile butadiene latex (NBL) manufacturing plant there.
Supermax Corp Bhd said today the rubber glove manufacturer has issued a scam alert, claiming that certain unauthorised parties are taking advantage of the global shortage of gloves and Supermax's prominence and good standing to attempt and commit fraud.
The government has no plans to impose a windfall profit levy on rubber glove manufacturers that are enjoying supernormal profits from the higher demand and selling price of rubber gloves worldwide nor to other businesses that have profited greatly due to the COVID-19 pandemic, according to the Ministry of Finance (MoF).
Kossan Rubber Industries Bhd can sustain strong demand of its rubber gloves with orders filled up till end of 2021, despite temporary factory closure, Kenanga Research said. Its average selling price (ASP) could play catch up in the fourth quarter (Q4) ending December 31, 2020 and in the first quarter (Q1) ending March 31, 2021, the firm added.
The production of natural rubber (NR) increased 5.4% in October 2020 to 48,663 tonnes from 46,187 tonnes in the previous month. Compared with the same month in the previous year, it rose 0.3%, said the Department of Statistics Malaysia (DOSM) in its monthly rubber statistics report for October 2020.
Singapore-listed Riverstone Holdings Ltd may not be a popular stock among local investors here, but the Malaysia-based nitrile cleanroom glove maker is actually one of the world’s largest listed glove companies in terms of revenue after the Big Four.
Top Glove Corp Bhd expects the average selling price of its gloves to jump 30% in the second quarter ending Feb 28, 2021 (2QFY21) from what was recorded in 1QFY21, boosted by continued strong demand for the product amid the ongoing pandemic, which has continued to see spikes of infections around the world. The higher ASP will also be a result of higher raw material prices and operation costs.
Hartalega Holdings Bhd won the coveted The Edge Billion Ringgit Club (BRC) Company of the Year award for 2020, the 11th edition of the award to honour Corporate Malaysia’s crème de la crème. Due to the ongoing conditional movement control order (CMCO) in Kuala Lumpur and Selangor, the annual gala dinner and award presentation was not held. Nonetheless, a total of 48 corporate awards were still presented to 35 companies this year to spur Corporate Malaysia on during the current tough patch.
Supermax Corp. is set to join bigger rivals Top Glove Corp. and Hartalega Holdings Bhd. in the benchmark FTSE Bursa Malaysia Index, thanks to the dizzying rally in its shares.The rubber-glove maker will replace KLCCP Stapled Group in the 30-member gauge starting Dec. 21, the exchange and the index provider FTSE Russell said in a joint statement.
The Covid-19 pandemic has been largely responsible for the surge in world demand for rubber gloves. As public health issues continue to disrupt economies and health systems, business analysts predict the robust demand for rubber gloves will continue indefinitely. Natural rubber was for years the preferred material for making rubber gloves. This has been largely attributed to its unmatched strength. No synthetic material can match natural rubber’s durability and dependability.
KAREX Bhd remains optimistic for stronger sales of condoms in the coming quarters despite physical-distancing rules to limit coronavirus spread denting sales worldwide. The world’s largest condom maker posted a net profit of RM4.46 million in the first quarter ended Sept 30, for the financial year 2021 (1QFY21), compared to a net loss of RM167,000 recorded in the corresponding quarter.
Malaysia, the world's largest producer of rubber gloves, on Wednesday said it does not anticipate any disruption to supply after a top manufacturer shut some factories due to a coronavirus outbreak among its workers.
Cranfield University researchers in partnership with Meditech Gloves, one of the leading manufacturers of high-quality examination and surgical gloves, have shown how energy savings can be made with the development of more sustainable, biodegradable, protein-free, natural rubber gloves.
Malaysia’s Medical Device Authority (MDA) announced (link in Malay) that the Malaysia Medical Device Register (MMDR) has been replaced by a new database, the Medical Device Authority Register (MDAR). Whenever a new medical device is authorized for distribution in Malaysia, it is added to the national register.
Budget 2021 has proposed that the four leading rubber glove manufacturers in the country will contribute a total of RM400mil towards efforts to combat the Covid-19 pandemic. The four firms comprise Top Glove Corp Bhd, Hartalega Holdings Bhd, Supermax Corp Bhd and Kossan Rubber Industries Bhd. At the tabling of Budget 2021, Finance Minister Tengku Zafrul Abdul Aziz said the companies have committed to help cover some of the costs, which include vaccine and medical equipment costs.
The Ministry of Plantation Industries and Commodities (MPIC), through the Malaysian Rubber Council (MRC), is always drafting and implementing short-, medium- and long-term plans to maintain Malaysia's global leadership in the production of rubber gloves. Minister Datuk Dr Mohd Khairuddin Aman Razali said that under the short- and medium-term plans, MRC will continue to carry out promotional activities overseas, such as participating in international trade expositions together with industry players, organise trade missions and educational seminars, business matching and advertising in international media.
Top Glove Corp Bhd said its annual rubber glove production capacity had reached 90 billion pieces as at October 2020 as the Covid-19 pandemic led to robust demand for its products to curb the spread of the outbreak. Top Glove said in its latest update on its website that its current glove production capacity involves 750 equivalent single former lines across 36 glove factories. "30% of production capacity is allocated for spot orders,” Top Glove said.
Online sales for house brand condoms manufactured by Malaysian company Karex shot up by seven-fold during the first half of this year, due to the national lockdown period which began in March, its CEO Goh Miah Kiat said. The demand for condoms at physical retail avenues, while suffering a dip when people's movements were restricted, has now recovered and even reported a gradual increase.
Malaysia’s Supermax Corp Bhd has proposed listing on the Singapore Exchange (SGX) to expand its shareholder base, it said in a bourse filing on Tuesday. Supermax, the third largest rubber glove maker in Malaysia by market value, said the proposed listing is still in the initial stages, with more details to be announced if and when its board finalises the plan and approves it. The potential listing comes after rival Top Glove Corp Bhd , the world’s largest producer of the medical protective gear, last month announced plans to list on Hong Kong’s stock exchange.
Karex Bhd has managed to improve its cash conversion cycle amid the challenges posed in managing inventories during initial stages of the COVID-19 pandemic due to improvements to credit controls and standardising payment terms. The condom manufacturer said this helped it continue to preserve agility on its balance sheet with a sustainable cash balance of RM46.3 million and shareholders’ funds totaling RM480.1 million, translating into a gearing ratio of 0.11 times for the financial year (FY) ended June 30, 2020. It pointed out that global logistic disruptions resulted in an inability to deliver finished goods to certain customers during the second half of the financial year.
The higher average selling price (ASP) of rubber gloves during the Covid-19 pandemic has analysts upbeat about Kossan Rubber Industries Bhd’s earnings. TA Securities analyst Tan Kong Jin, who is reiterating a “buy” call on the stock with a target price of RM10.30, said for its upcoming third quarter (3Q) 20 results, the brokerage expects the company to post another record net profit of more than RM300mil with significant earnings growth of more than 100% quarter-on-quarter (q-o-q) and year-on-year (y-o-y). Kossan Rubber is scheduled to release its 3Q results on Nov 19. Tan attributes this to the higher sales volume of around 10% and higher ASP of 30%.
Many medical device manufacturers will be strongly impacted by new requirements for more clinical evidence once the European Medical Devices Regulation (MDR) comes fully into effect in May 2021. In order to obtain and renew their CE Mark certifications, companies will need to collect this evidence via clinical investigations or post-market clinical follow-up (PMCF) activities. The proper conduct of medical device clinical activities will be regulated by the MDR, by national laws and regulations and finally by Good Clinical Practice (GCP) standards such as ISO 14155.
Hartalega Holdings Bhd is confident of sustained strong demand for its gloves with capacity having booked up till end of 2021, according to Kenanga Research. The firm "strongly" reiterated its positive view on Hartalega's prospects for the next few quarters following a meeting with its investor relations staff recently. Kenanga Research said Hartalega had reassured that the lagged impact from average selling price (ASP) hike would be felt in the second half of financial year 2021 (FY21). The firm highlighted that industry ASP had risen for September to November delivery, suggesting that the robust demand would continue over the next few quarters.
Malaysian rubber glove maker Top Glove Corp Bhd, riding a wave of demand generated by the coronavirus outbreak, has hired banks to arrange a Hong Kong listing that could raise at least US$1 billion, two sources said. Citigroup, China International Capital Corporation (CICC) and UBS will manage the listing, said the two sources, who have direct knowledge of the matter but can't be named as the information is not yet public. Another source, also declining to be named as the process is private, said the world's largest glove maker could be more ambitious and look to raise as much as US$2 billion.
Rubber time is an old reference that Malaysian used for a laid-back attitude, but when it actually involves rubber, it is not a concept the industry can afford to enjoy. To keep up with the rapid evolution of technology, rubber industry players must now be nimble and embrace change ¬ an ethos that the Malaysian Rubber Council (MRC) intends to inculcate. “The world will not wait for us so the rubber players must ensure that we move in tandem with the ever-evolving world. There are things we must unlearn and relearn, and to accept new ideas and fresh ways of doing things,” says MRC chairman Raja Datuk Idris Raja Kamarudin.
FGV Holdings Berhad (FGV) has announced that it will be expanding its rubber business to Europe and North America markets through its subsidiary, FGV Rubber Industries Sdn Bhd (FGVRI) with the appointment of Rubber Heart Ltd (RHL). In a statement today, FGV said the appointment of RHL, a rubber marketing agency based in the United Kingdom, includes developing strategic marketing and sales of its various grades of high-quality technically specified rubber and another specialty — natural rubber-based materials exclusively for the countries in these continents.
There’s a worldwide shortage of nitrile gloves, and it could stretch for more than a year into the first half of 2022 due to a lack of raw materials. This may lead to Hartalega Holdings Bhd, one of the world’s largest nitrile gloves producers, raising its average selling price (ASPs) “more aggressively” in the coming quarters, according to Maybank IB Research. For the second quarter ending Sept 30, the research house expected Hartalega to increase its ASPs by 30% from the first quarter, and 40% to 50% in the third quarter.
The US Food and Drug Administration published a proposed rule in September 2020 to update the language used to define intended use in relationship to both medical devices and drugs. This should be carefully reviewed by manufacturers, and action is recommended. The 2020 proposed rule provides improved clarity from the 2015 and 2017 rules. However, there are still significant questions related to the language of “solely.”
Rubber gloves manufacturer Top Glove Corp. Bhd has seen its financial results soar over the past year, with the outlook for the industry “very promising” in the short-term. Profit after tax grew 417% year-on-year to RM1.9 billion (€391 million) for the financial year ended 31 Aug, as sales increased 51% to RM7.2 billion, Top Glove said in its annual financial report 17 Sept. Most robust was demand for nitrile gloves which grew by 31% year-on-year, while natural rubber examination gloves also saw a growth of 7% compared to last year.
Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. The first round of changes to Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) took effect September 1, 2020. Additional revisions will come into force in August 2021 and December 2022.
The global demand for gloves is likely to continue outstripping supply for the next three to four years, even if a vaccine for the Covid-19 becomes available, according to Hartalega Holdings Bhd. The world’s largest nitrile glove maker says the consumption of gloves worldwide will continue to increase because of changes in user behaviour. “Demand in developed countries has increased 30%, while in developing countries, demand has more than doubled, ” Mun Leong said.
In the new guidance, FDA addresses how to request recognition of a consensus standard, decisions on complete or partial recognition of a standard, and how it arrives at non-recognition when a standard does not satisfy regulations. It may also withdraw recognition of a previously recognized standard, when that standard is replaced by a new version, or when the standard is no longer appropriate for meeting a requirement.
Malaysia’s rubber gloves exports grew by 50.1 per cent to RM15.06 billion for the January-July 2020 period from RM10.03 billion in the same period last year, said the Ministry of International Trade and Industry. Deputy Minister Senator Datuk Lim Ban Hong said the growth was driven by higher demand and government’s efforts to assist the rubber gloves industry.
Kuala Lumpur Kepong Bhd (KLK) has appointed Texas headquartered industry-specific software designer Epicor Software Corp to integrate the systems and automate business processes for its latex rubber household and industrial gloves manufacturer unit. In a statement Sept 8, KLK said its unit KL-Kepong Rubber Products Sdn Bhd (KLKRP) is integrating its systems for efficiency and growth.
For the past two decades the nation’s rubber downstream industry has been guided by the Malaysian Rubber Export Promotion Council (MREPC), which has seen the sector grow to a level where our rubber products are now exported to 195 countries and in 2019 generated RM23.3bil worth of export earnings. However, with rubber now having to compete in a more dynamic and competitive environment, there is a need to transform the commodity into a high value-added industry that keeps pace with advancement of technology and needs of the market.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.
Petronas Chemicals Group Bhd (PetChem) and LG Chem have inked an agreement to build a nitrile butadiene latex (NBL) manufacturing plant at Pengerang Integrated Complex (PIC) in Johor. PetChem said in a press release that this facility will further help strengthen Malaysia’s position as the largest exporter of rubber gloves globally. They also added that the the collaboration will create new revenue streams and unlock new markets by optimising resources in both companies.
Medical device regulators at the US Food and Drug Administration have issued final guidance for two device types now qualified to obtain faster market access via the agency’s Safety and Performance Based Pathway. The two final guidances cover cutaneous electrodes for recording purposes and conventional foley catheters, both Class II devices under the FDA classification system, respectively.
With the Chinese products not being utilized by some of the countries, the focus has now been shifted to the other South East Asian Nations in the ASEAN belt who are currently producing almost 85% of the world’s gloves needs. Be it Hartalega Sdn Bhd and Top Gloves in Malaysia, Nam Viet in Vietnam, every manufacturer is growing leaps and bounds. ASEAN countries have become the largest suppliers of gloves in the world.
With the Chinese products not being utilized by some of the countries, the focus has now been shifted to the other South East Asian Nations in the ASEAN belt who are currently producing almost 85% of the world’s gloves needs. Be it Hartalega Sdn Bhd and Top Gloves in Malaysia, Nam Viet in Vietnam, every manufacturer is growing leaps and bounds. ASEAN countries have become the largest suppliers of gloves in the world.
Kanger International Bhd will invest RM77 million to set up a glove manufacturing plant in Ijok, Selangor as early as next year and export the output to the Arab region. Kanger will acquire five acres in Ijok for RM6.8 million through its wholly owned Kanger Glove Manufacturing Sdn Bhd. Kanger Glove will spend about RM70 million to build the plant and install up to eight production lines to produce medical, surgical and/or nitrile gloves.
The rubber glove industry seems like a desirable exclusive club that others want to be associated with, judging by the slew of companies that have announced plans to enter the industry, which is currently flooded with new orders at higher average selling prices. Yesterday, four more companies announced plans to set up plants to produce rubber gloves. There were three that announced similar plans the day before.
The US Food and Drug Administration plans seven-percent medical device user fee increases for the 2021 fiscal year, raising costs slightly for premarket submissions including 510(k) Premarket Notifications, Premarket Authorizations (PMA) and De Novo requests for classification. FDA’s new Medical Device User Fee Amendment (MDUFA) fee schedule comes into effect October 1, 2020, the start of the agency’s 2021 fiscal year.
Plantation Industries and Commodities Minister Datuk Dr Mohd Khairuddin Aman Razali said MRC has been rebranded from the Malaysian Rubber Export Promotion Council to reflect the expanded agency’s role in the development of the downstream rubber industry, human capital and advanced technology adoption as well as investment promotion of the country's rubber industry.
The recovery in the Malaysian manufacturing sector continued in July, according to the headline IHS Markit Malaysia Manufacturing Purchasing Managers' Index (PMI). After rising at a joint-record pace in June, output continued to expand in the latest survey period, with trends in new orders much improved since the nadir of the Covid-19 downturn in April. Encouragingly, manufacturing production rose for the second month running in July, building on the joint-record expansion registered in the previous month.
Malaysian businessman Tan Sri Lim Wee Chai is certainly the man of the hour. He is going places no Malaysian tycoons have. The boss of Top Glove Corporation Bhd, the world’s largest gloves manufacturer, has found his company placed as third largest market capitalisation listed on Bursa. Top Glove is expected to create Malaysian history soon by announcing the biggest jump in quarterly profit for a listed company.
Malaysia’s exports in June saw a strong rebound as economies globally reopened, paving the way for a good uptick in economic activities in the second half of the year. The main products which contributed to the expansion in exports were electrical and electronic products, rubber products, palm oil and palm oil-based agriculture products, optical and scientific equipment and machinery, equipment and parts.
Top Glove Corp Bhd and Supermax Corp Bhd will undertake bonus issues to reward shareholders after their shares hit all-time high yesterday. Top Glove, Supermax and other local glove manufacturers are posting supernormal profits after global demand for gloves surges to its highest following the Covid-19 pandemic. Executive chairman Tan Sri Dr Lim Wee Chai said the bonus issue would enable it "to fulfil our commitment to our loyal shareholders.
Under the 21st Century Cures Act, FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I devices and more than 1,000 Class II devices from 510(k) requirements in accordance with the act.
The government will extend the use of natural rubber in road construction throughout the country this year, said Deputy Works Minister Datuk Eddin Syazlee Shith. He said this will be implemented through the RM140-million allocation under the Prihatin Rakyat Economic Stimulus Package (Prihatin). This will help to further diversify the use of local rubber and increase the income of smallholders.
Malaysia’s largest rubber glove manufacturer Top Glove is investing US$1 billion over the next five years to expand its production capacity, in order to meet surging demand for protective gloves amid the COVID-19 pandemic. Speaking to CNA in an exclusive interview, Top Glove’s executive chairman and founder Lim Wee Chai noted that the company’s third-quarter earnings ending May 31 jumped more than three times to hit almost US$90 million, while its share price has quadrupled since the beginning of the year.
Over the last two months, Malaysia’s Medical Device Authority (MDA) has issued three noteworthy guidance documents relating to post-market surveillance. These expand on the responsibilities of medical device establishments after bringing a product to market, as defined in the Medical Device (Duties and Obligations of Establishments) Regulations 2019, which are now effective as of July 1, 2020.
The demand supply imbalances of the glove industry is expected to normalise after 2022, as average selling prices (ASPs) decline. These expectations have been factored into the earnings forecast of local glove makers, which show a dip in earnings for 2022, after a run-up in 2020 and 2021. An analyst said the decline in earnings forecast for financial year 2022 (FY22) does not come as a surprise and is widely expected.
The heightened border dispute between India and China presents an opportunity for Malaysia to boost exports to India as the South Asian country plans to impose strict rules and tariffs on Chinese goods, said MIDF Research. This is on top of the global disruption of raw material supplies from China as a result of the COVID-19 pandemic, prompting key importing countries including India to consider import substitution or diversification.
Malaysian glove makers are among the few companies whose shares are benefiting from the novel coronavirus pandemic, as Asia demands higher standards of public hygiene. Among the roughly 320 components of the Nikkei Asia300 stock index, only 58 issues, or 18%, have risen in the first half of 2020, while more than 260 have lost ground. Overall, the Asia300 stock index was down 7.5%, at 1288.36, as of Tuesday's close.
The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking. In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Device Identification Database (GUDID) data submission requirements for class I and unclassified devices until 24 September 2022.
Since the start of the Covid-19 outbreak early this year, listed rubber glove makers have been hogging most of the limelight in the market. Their superb share price performance has greatly increased the fortunes of Kuan Kam Hon, Tan Sri Dr Lim Wee Chai, Tan Sri Lim Kuang Sia and Datuk Seri Stanley Thai Kim Sim — the four most prominent glove tycoons in the country.
China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. CMDE Announcement No. 17 of 2020 stipulates registration withdrawal and re-application procedures for imported medical devices that were submitted for registration as Class II devices but upon technical review were found to fall into Class III.
Malaysia, a country that produces about 65% of the world’s supply for rubber gloves, now counts at least four billionaires whose fortunes were made in the industry, including two new ones this year alone. Thai Kim Sim of Supermax Corp was the latest to join the club, with a net worth estimated at about US$1 billion at the stock high earlier this month, according to the Bloomberg Billionaires Index.
On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Overseeing harmonization of standards falls to the European Commission. In 2014, the European Court of Justice ruled that harmonized standard should be understood as the law, which in a way would make the European Commission into a lawmaker. This goes against the normal structures of legislating in the EU, so it was necessary to make significant changes in how harmonized standards are developed.
Supermax Corp Bhd is buying a 2.02ha plot of land in Klang, Selangor for RM21.78 million for the future expansion of the group’s manufacturing capacity, it said in a bourse filing today. Its wholly-owned unit Maxter Glove Manufacturing Sdn Bhd yesterday entered into a sale and purchase agreement with two individuals, Goh Chee Seong and Lee Ah Mooi, for the freehold land in Meru, near its existing cluster of manufacturing plants.
The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at increasing efficiency and allowing regulators to focus their efforts on critical activities. The draft guideline applies to regulatory activities for a range of medical products, including drugs, vaccines, blood/blood products, medical devices and in vitro diagnostics, and covers the total product lifecycle for those products.
The new Regulations are very similar to the ASEAN Medical Device Directive’s (AMDD) guidance, however the MDA expands on the procedures and defines Malaysia-specific record keeping requirements and penalties. The new Regulations detail the criteria for reportable AEs, the information needed to maintain and support an effective and timely recall and the process of field corrective and/or preventive actions.
The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).
Supermax Corporation Bhd' has completed the sale and purchase agreement with Nishimen Industries (M) Sdn Bhd for a five-acre site in Klang, Selangor for RM20 million. Supermax said it would build its 16th manufacturing plant on the land bought through its wholly-owned Maxter Glove Manufacturing Sdn Bhd. The five-acre industrial plot known as Lot 6062, is located next to Supermax's existing cluster of manufacturing plants.
The new regulation (Implementing Regulation (EU) 2020/666) amends Implementing Regulation (EU) 920/2013 pertaining to Notified Body (NB) designation renewals to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD); European regulators intend the new regulation to help qualifying NBs maintain their ability to issue CE Mark certifications to medical device manufacturers under the MDD and AIMDD over the next 12 months, helping ensure adequate supplies of medical devices and equipment during the coronavirus pandemic.
The government can expect to collect more tax revenue from the rubber glove industry this year that can partially make up for reduced overall collection from most economic sectors. Analysts expect rubber glove companies to post "super bumper" earnings on a spike in demand of the products following the Covid-19 pandemic.
The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic.
Fears of a second wave of coronavirus (Covid-19) pandemic lifted glove makers, hand sanitiser-related firms and healthcare companies. This was despite the overall weak market sentiment on Bursa Malaysia and other regional markets. Yesterday, the world’s largest glove manufacturer Top Glove Corp Bhd was the top gainer, surging 9.3% or 68 sen to close the day at RM7.99 per share, its highest ever. Other big companies, namely Kossan Rubber Industries Bhd, Hartalega Holdings Bhd, Supermax Corp Bhd were also hogging the top gainers list.
The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday released a new guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the Medical Devices Regulation (MDR). The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively.
Rubberex Corp (M) Bhd is planning to undertake a private placement to raise RM31 million to expand its production lines for nitrile gloves. In a bourse filing, the group said it would issue 25.22 million new shares, representing 10% of its share capital of 252.2 million shares. Upon completion of the placement, the group’s share capital will increase to 277.43 million shares.
In its annual sector survey, the European notified body group Team-NB found a nearly 50% uptick in the number of new CE certificates issued in 2019 as medical device makers rushed to obtain the certificates before the application of the EU Medical Device Regulation (MDR). While the MDR is now officially delayed by one year, companies planning for the transition in 2019 were braced for the regulation to take effect later this month.
The government has allowed all ports under its jurisdiction to resume import and export activities effective Wednesday (April 29), says Datuk Seri Dr Wee Ka Siong. The Transport Minister said companies granted approval by the Ministry of International Trade and Industry (MITI) would be allowed to operate within the policies of the National Security Council (NSC).
The European Council voted 27-0 on Wednesday to adopt an amendment to delay the application of the Medical Devices Regulation by one year and allow for EU-wide derogations for certain medical devices needed in the response to the coronavirus disease (COVID-19) pandemic.
Investors were seen to be booking profits on rubber glove stocks yesterday, following spikes in these counters to multi-year highs amid the Covid-19 outbreak, which drove the demand for rubber gloves. Among the big four rubber glove stocks, the counter that declined the most by percentage was Hartalega Holdings Bhd, which fell 5.47% to close at RM7.25 for a market capitalisation of RMRM24.53 billion.
The European Parliament on Friday voted 693-1 with two abstentions to postpone the Medical Devices Regulation (MDR) by one year to 26 May 2021 two weeks after the European Commission proposed the delay in light of the disruption caused by the coronavirus disease (COVID-19) pandemic.
Top Glove Corp Bhd, the world’s largest glove manufacturer in terms of capacity, saw its market capitalisation (cap) hit a record high of RM17.09 billion yesterday, as its share price climbed 17 sen or 2.6% to settle at RM6.67. Likewise, its rival Hartalega Holdings Bhd’s share price has also been on the climb. Hartalega’s share price closed at RM7.42 yesterday, its highest in about three years, with a market capitalisation of RM25.10 billion.
The Ministry of Plantation and Commodity Industries (MPIC) today reminded rubber glove industry players to comply with the directives set by the government in their operations. Deputy Minister Willie Mongin revealed that the MPIC has received reports against two rubber glove operators for allegedly violating regulations that could lead to environmental pollution.
The guidance covers certifications under the European Medical Devices Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD) and Active Implantable Medical Devices Directive (AIMDD), but may also apply to the upcoming Medical Devices Directive (MDR) and In-vitro Diagnostic Medical Devices Directive (IVDR) depending on the extent of the coronavirus pandemic as well as the final dates of application for the new Regulations.
European Union member states face similar crises as the US and other countries regarding shortages of medical devices and equipment needed to treat COVID-19 patients, driving the need for emergency access to European healthcare markets for these products at a faster rate than for the standard conformity assessment routes to obtain a CE Marking certification.
The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site audit or verification and in cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a notified body and enters into a contract with another notified body.
As the number of COVID-19 cases increase in the US and hospitals struggle with keeping their doctors and nurses protected, the Food and Drug Administration (FDA) on Monday released guidance explaining how it will relax certain regulatory requirements to increase the production and availability of certain personal protective equipment (PPE) such as gowns and gloves.
The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous injections, sterilization devices and disinfectants and alter particular requirements for emergency and transport ventilators, among others.
The Malaysian Rubber Export Promotion Council (MREPC), an agency under the Ministry of Plantation Industries and Commodities, and the Malaysian Rubber Glove Manufacturers Association (MARGMA) have pledged to donate five million medical rubber gloves to the Ministry of Health and agencies such as the Royal Malaysia Police, Immigration Department, and Fire and Rescue Department. Plantation Industries and Commodities Minister Datuk Dr Mohd Khairuddin Aman Razali, in a statement today, said the contribution would help reduce the burden of the government during these difficult times.
To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Tuesday eased import requirements for certain products. Typically, companies importing FDA-regulated products are required to submit entry information to the agency for the products. However, to ease burdens on importers and speed up the entry process for PPE and certain devices intended for emergency use or covered by an enforcement discretion policy, FDA is reducing the amount of information that needs to be submitted.
The government announced partial exemptions of the movement control order to permit the palm oil, rubber, and timber sectors resume operations on a restricted scale. Plantation Industries and Commodities Minister Datuk Mohd Khairuddin Aman Razali said palm plantations may proceed only with harvesting and processing fresh palm fruits. He said in a statement today that rubber tapping for the purpose of supplying raw materials to manufacture medical items such as gloves and catheters would also be allowed to operate minimally
While acknowledging the implementation of the new EU medical device and in vitro diagnostic regulations (MDR and IVDR) has proven to be a “very challenging task,” the EU’s Medical Device Coordination Group (MDCG) last week outlined its plan for actions considered essential to have an operational system under MDR in place by 26 May. Evolving relationships between the EU and Turkey, and the EU and Switzerland, also add further stress for some devices.
Covid-19 will have a positive impact on earnings for the rubber products (gloves) sector, analysts project, given the recent demand surge due to the outbreak. Affin Hwang Investment Bank Bhd (AffinHwang Capital) is expecting a stronger 2020 for the rubber sector, as the research firm believed that the sector would likely benefit from stronger demand arising from Covid-19 and a weak ringgit against the US dollar.
Regulation of medical devices in the U.K. has been directly shaped by EU directives for decades. However, that is poised to end, possibly as soon as the start of next year. In anticipation of the split, the U.K. government created the Medicines and Medical Devices Bill 2019-20 and had its "first reading" last month. The bill will empower the government to update existing, EU-derived legislation after the U.K. leaves the EU.
Despite overall sector performance falling below market expectations, the Malaysian rubber glove sector could experience a stronger 2020 performance on the back of stronger demand arising from Covid-19 and a weaker ringgit against the US dollar. Affin Hwang Capital research remains overweight on the sector and increased its earnings forecasts for 2020 by 2% to 3% as it expects stronger earnings growth in the first half of the year due to the Covid-19 outbreak.
Come May 26th 2020, all manufacturers aiming to market their medical devices within the European Union (EU) will be required to conform to the Medical Devices Regulation (MDR) and all harmonized standards. Emergo by UL's Human Factors Research & Design (HFR&D) team helps our clients prepare for this date in part by ensuring they have completed a robust usability engineering process that demonstrates conformance with the new regulations. In the run-up to May 26th, our team will present a series of blogs providing information related to the usability engineering process, its requirements, and methodologies as it applies to the MDR.
Glove counters continued to gain attention from investors today amid the continuing spread of the coronavirus (Covid-19), while the weakening ringgit also further lifted sentiment for glove makers, against the backdrop of the freefall of the broader market on political uncertainties. The share price of Top Glove Corp Bhd, which led the surge among glove makers, rose as much as 4.16% or 22 sen at RM5.51, before it pared some of its gains at RM5.45, bringing it a market capitalisation of RM13.90 billion.
As part of its commitments under the Medical Device User Fee Amendments (MDUFA IV), the US Food and Drug Administration (FDA) on Wednesday announced a pilot to test a new, interactive, PDF-based 510(k) template. According to FDA, the electronic Submission Template and Resource (eSTAR) features automation, integration with other resources and a structure that is more aligned with the Center for Devices and Radiological Health's (CDRH) internal review templates.
Local rubber glove makers are estimated to chart strong improvement in their financial performance for financial year 2019 (FY19) and FY20, underpinned by higher demand for rubber products and resolved labour issues. An analyst said companies, which were temporarily hit by the labour shortage, had resolved the issues late last year which enabled their factories to be fully operational at the highest capacity.
Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry. The bill was read for the first time in the House of Commons on Thursday and is scheduled for a second reading on 2 March.
The growth of rubber products exports is expected to return to positive in 2020, contributed mainly by the increase in capacity and production of major glove players, as well as new investments in the dry rubber sector, specifically tyres, automotive parts and industrial goods, according to the Malaysian Rubber Export Promotion Council (MREPC). It said the unexpected surge in demand for rubber gloves due to the Wuhan novel coronavirus outbreak will support the growth of the overall rubber products exports in 2020.
China's National Medical Products Administration (NMPA) is fast tracking the processing of requests to manufacture and sell face masks and other pieces of medical equipment capable of slowing the spread of the coronavirus. NMPA has created the fast track to encourage manufacturers of medical clothing to add capacity, reassign existing capacity to products related to coronavirus or enter the Chinese market for the first time.
The Malaysian Rubber Export Promotion Council (MREPC) and several glove manufacturers here will donate 18 million medical gloves to Wuhan in China that is facing an outbreak of the novel coronavirus (2019-nCoV). Primary Industries Minister Teresa Kok announced this today during a special press conference at her ministry here.
KUALA LUMPUR/SINGAPORE (Feb 6): Lim Wee Chai heads the world's biggest glove-maker, with 43 factories that can churn out 70.5 billion pieces every year. The coronavirus is putting those facilities to the test. "We have seen a surge in glove demand, especially from China, Hong Kong, Singapore and Taiwan," said Lim, the 62-year-old founder and executive chairman of Malaysia"s Top Glove Corp. "Over the past week, the total sales orders received are equivalent to more than double our usual sales to China."
Malaysia's GDP is expected to grow by 4.4% in 2020, rather similar to the economic growth that was recorded in 2019, according to the Economist Intelligence Unit (EIU). The Economist Corporate Network South-East Asia director Pamela Qiu said Malaysia can expect to reap strong benefits in the automotive and ICT sectors, as investors look to relocate from China in response to trade war tensions.
KUALA LUMPUR: The world's largest glovemaker, Top Glove Corporation, could beat its 2020 sales growth target of 10-15% due to the spread of a new coronavirus in China, the Malaysian firm's executive chairman said on Wednesday. "Over the past few days, the total sales orders received are equivalent to more than double our usual sales to China," Lim Wee Chai told Reuters via email.
Shares in Bursa Malaysia-listed glovemakers jumped this morning as fears of a global epidemic are mounting after the deadly person-to-person transmission of a Severe Acute Respiratory Syndrome (SARS)-like virus killed four in 200 confirmed cases identified in China so far. The news corresponded with the spike in trading and share price of the world's largest rubber glove manufacturer Top Glove Corp Bhd. Top Glove saw its stock price surge as much as 33 sen or 6.8% to RM5.15 within the first hour of trading, making it the biggest gainer on the local bourse.
The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, along with more than 100 other consensus standards. The move came shortly after ISO released the new version of the standard, now in its third revision, and extended FDA recognition to dozens of other consensus standards developed by ISO, the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International and the United States Pharmacopoeia (USP), among others.
A supply-demand imbalance is expected in 2020 with glove players expected to increase supply by about 14% (versus an annual global demand growth of 8% to 10%). However, we feel this will eventually normalise with an increase in glove demand from the US (due to the US-China trade war, Chinese gloves become more expensive, hence making Malaysian gloves more attractive).
The US Food and Drug Administration (FDA) last month altered and finalized a 2014 draft guidance explaining what information needs to be provided in annual reports for medical devices subject to premarket approval (PMA). In terms of the changes between the draft and final version, FDA clarifies the wording on its expectations and offers further detail on what it's looking for in the report.
Top Glove Corp Bhd expects its production of nitrile gloves to grow rapidly, with volume firmly surpassing that of low-margin latex gloves by the end of the year. According to its group executive chairman Tan Sri Lim Wee Chai, the company is expected to achieve a product mix of 55:45 between nitrile and latex by end-2020, compared with the existing composition of 50:50.
India has extended the transition to new rules for certain medical devices by 12 months. Regulators were due to start treating a clutch of devices as drugs on 1 January, but have given the industry more time to adapt. The delays follow shortly after the Indian government published draft legislation that would increase regulatory oversight of all types of medical device.
On the back of a positive results season, the rubber gloves sector is seeing signs of an uptick in demand in subsequent quarters, says Kenanga research. In a note, the research house said the 3Q results season came within expectations with volume growth of 6% and 14% recorded by Top Glove and Hartalaga respectively. It said its ground checks showed demand for nitrile gloves is picking up again and players' new capacities are being swiftly taken up. Based on its analysis, nitrile gloves market share could experience 30% growth in 2020.