The US Food and Drug Administration has finalized details of a new registration route for breakthrough medical devices first announced in 2017. Final guidance from FDA on its Breakthrough Devices Program covers cutting-edge medical devices as well as combination products with devices as primary components developed to more effectively target life-threatening or debilitating diseases and health conditions.
Malaysia's new National Automotive Policy (NAP) which will be unveiled by year-end is expected to focus on next-generation vehicles which are smart and connected, as well as utilising green technology. Malaysia Automotive, Robotics and Internet of Things Institute (MARii) Chief Executive Officer Datuk Madani Sahari said the NAP would also look into mobility as a service.
The 0.7 per cent average increase in natural gas tariff is expected to only marginally impact rubber gloves playersâ€™ earnings. It will be by 0.2 per cent to 0.5 per cent based on Kenanga Investment Bank Bhdâ€™s back-of-envelope calculations, assuming a â€œno-cost pass throughâ€. Kenanga IB said fuel accounted for an average of 10 per cent of production cost, of which natural gas making up for an average of seven per cent of the production cost.
The Human Resources Ministry has appointed Klang MP Charles Santiago as the coordinator of an independent auditor to carry out a comprehensive social compliance audit on rubber glove makers in the country. Minister M. Kula Segaran said Charles, an experienced activist involved in social audit nationwide before being elected as a people's representative, was tasked to prepare reports to the ministry pertaining to the country's rubber glove makers' compliance to the International Labour Organisation (ILO) Standards on Migrant Workers.
Glovemaker Top Glove Corp Bhd said measures have been put in place to prevent its workers from working "overtime" (OT) in excess of the allowed 104 hours a month. The group, in a filing with the stock exchange, said the measures had been implemented on a staggered basis across all its factories between March and November 2018.
Health Canada has issued a final email reminder to medical device companies regarding the regulator's December 31, 2018 deadline for transitioning to the Medical Device Single Audit Program (MDSAP) for quality management system compliance. According to the Health Canada notice, all Medical Device License (MDL) holders of Class II, III and IV devices must provide evidence of MDSAP transition to the agency before December 31. Companies that fail to do so may face suspension of their MDLs.
We recently visited Kossan Rubber Industries Bhd's state-of-the-art plant 16 which commenced operations in August 2018. The plant houses eight production lines with an annual installed gloves production capacity of three billion pieces. The plant's efficiency level at the product handling stage - the packaging and warehousing - is currently at 2.5 workers per million gloves - lower compared with the group's average handling capability of three workers per million gloves, mainly due to a higher automation level.
Top rubber producers Thailand, Malaysia and Indonesia will meet on Dec 16 to discuss ways to prop up distressed prices, including potentially curbing exports, a senior Indonesian trade official said on Wednesday. Representatives from the three countries which comprise the International Tripartite Rubber Council (ITRC) will meet in Putrajaya, Malaysia, according to Iman Pambagyo, Director General of International Trade Negotiation at Indonesia's Trade Ministry.
Malaysia External Trade Development Corporation (MATRADE) has recorded RM257.74 million in export potential during the recent participation in MEDICA 2018 in Dusseldorf, Germany from November 12-15, 2018. The premier healthcare trade event was represented by 10 Malaysian companies in various medical devices sectors such as diagnostic and test kits, sanitisers and disinfectants, medical graph paper, innovative sheath contraceptives and medical components.
Comfort Gloves Bhd's examination gloves will no longer need to be inspected prior to their entry into the US, after wholly owned subsidiary, Comfort Rubber Gloves Industries Sdn Bhd (CRGISB) was taken off the US Food & Drug Administration (US FDA) Import Alert List.
INVESTORS who baulked at buying glove stocks at the end of last year, because they believed valuations were too stretched, could be kicking themselves given that the share prices of the four largest glove manufacturers have outperformed the market by a long shot. The average share price gain of HartaÂlega Holdings Bhd, Top Glove Corp Bhd, Kossan Rubber Industries Bhd and Supermax Corp Bhd over the past year has been a whopping 65.2%.
A draft agreement on Brexit has been struck between EU and UK negotiators. Notified Bodies will remain recognized during the transition period. It is not certain this agreement will be accepted; a cliff-edge Brexit remains a possibility. British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU).
The Malaysian Medical Device Authority (MDA) has rolled out two new databases for medical device registration information. The first database, the Registered Medical Device Search, is accessible to the public and searchable by either device name or MDA registration number. Search results from this database may be used to confirm classifications of registered devices, Malaysia Authorized Representatives and registration expiration dates.
The suspended Rubber City project in Kedah, which aimed to attract investments close to RM10 billion, will be implemented next year. Economic Affairs Minister Datuk Seri Mohamed Azmin Ali (picture) said the project's implementation has been approved in the National Physical Planning Council meeting, chaired by Prime Minister Tun Dr Mahathir Mohamad.
The Primary Industries Ministry (MPI) will not implement a floor price for rubber as it will incur high costs and encourage smuggling as global rubber prices see a downturn, the Ministry said in a statement Tuesday (Nov 6). It said based on 2017 production, if the rubber floor price is set at RM4 per kilogramme from the current price of RM2.20 per kilogramme, it will cost the government RM2.5 billion a year.
In the swirling waters of the global economy, it can be hard to keep up with every new development. However, this October marks an important regulatory milestone that should not pass by unnoticed. While the reference at the top of this article may be a little misplaced (thanks to Brexit), please allow the proverbial Paul Revere to direct your attention to the following: We are now halfway through the three-year transition period between the European Union's old directive for regulating medical devices, and the new Medical Device Regulation. The new directive goes into full effect in May of 2020.
The South Korean Ministry of Food and Drug Safety (MFDS) has issued draft plans to align Korea Good Manufacturing Practice (KGMP) more closely to the ISO 13485:2016 medical device quality system standard. MFDS is seeking comment from industry on its draft plan (link in Korean) until November 29, 2018. Harmonizing KGMP requirements with the latest edition of ISO 13485 would improve quality control and establish more rigorous criteria for desktop audits for quality system compliance, states MFDS.
Several Southeast Asian countries are finding ways to protect their emerging car industries from imports, after eliminating auto duties by the end of last year. Indonesia, Vietnam and Thailand have introduced measures either to hinder imports or benefit local production, while Malaysia is looking at possible curbs on foreign car sales. The new trend is emerging as countries try to push down their trade deficits or bolster their economies in the short term. But experts say the moves may weaken Southeast Asia's auto industry in the long run.
Top Glove Corp Bhd's profit after tax and minority interest (Patami) for financial year 2018 (FY18) of RM433.6 million (+31.9% year-on-year [y-o-y]) came in within expectations at 96%/98% of our/consensus full-year forecasts. A final dividend per share (DPS) of 10 sen was proposed, bringing full FY18 DPS to 17 sen (FY17: 14.5 sen), which is above our expectations. As such, we raise both our FY19 and FY20 DPS estimates from 14.5 sen to 17 sen each. The one-for-one bonus issue will go ex on Oct 24.
New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS). The guidance is intended to explain how sponsors whose medical device and pharmaceutical clinical investigations must meet both FDA clinical investigation regulations for human subject safety and informed consent as well as HHS's "Common Rule" for human subject protections should address compliance issues
Top Glove Corp Bhd,which saw its net profit rose 7.51% to RM101.59mil in the fourth quarter ended Aug 31, has declared a final dividend of 10 sen per share. The glove maker said the latest dividend would bring the total financial year ended Aug 31, 2018 (FY18) dividend payout to 17 sen per share, an increase of 2.5 sen or 17% over FY17, representing a net profit payout ratio of 50%. It added that the dividend would be subjected to shareholders' approval at the upcoming AGM in January 2019.
PRIME Minister Tun Dr Mahathir Mohamad's proposal to launch a third national car project is set to proceed. The project will be an all private sector initiative, thus there is no government support in terms of funding. The government will assist if necessary. Initially there was an intention to seek assistance from Japanese automakers such as Toyota and Nissan, but now the ambitious project would require no external help, instead it will be an all-Malaysian undertaking led by Malaysian Industry-Government Group for High Technology (Might).
Hartalega's expansion plans are on track with the commissioning of its latest next generation integrated glove manufacturing complex plant, Plant 5 and the beginning stages of constructing Plant 6. Plants 5 and 6 are expected to increase capacity by 4.5 billion pieces per annum each.
Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency's Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications.
Deputy Primary Industries Minister Shamsul Iskandar Mohd Akin will lead a palm oil and rubber economic and investment mission to Egypt, Morocco and Colombia from Sept 21-29. The mission delegation would comprise representatives from the Ministry of Primary Industries, Malaysian Palm Oil Board, Malaysian Rubber Board, LGM Properties Corporation, Malaysian Palm Oil Council and Malaysian Rubber Export Promotion Council.
The third national car project will gear Malaysia for the next phase of growth in the automotive industry with battery-based power-trains and autonomous navigation being the dominant technologies and the convergence of new technologies creating a new mega sector called Connected Mobility, says the Malaysia Automotive Institute (MAI). Chief Executive Officer Datuk Madani Sahari said the mega sector is expected to be created from the convergence of new technology areas such as nanotechnology, telecommunications, big data management and even sectors such as human resource management, marketing, legal and urban planning that would become more relevant to the transport sector.
PRIME Minister Tun Dr Mahathir Mohamad made two penetrating comments on research and development (R&D) when he officiated at the recent International Rubber Conference in Kuala Lumpur. First, he encouraged the rubber industry to carry on with research in product development to raise global use of this commodity, supplied by many small farmers in Malaysia. "Rubber was introduced from Brazil, while oil palm was brought in from West Africa, but it is amazing how these crops are now used to bring great economic returns to (Malaysia)," he said. Both crops have benefited here from solid R&D, coupled with strong government-industry links.
Canadian medical device regulator Health Canada is preparing a pilot for a new program allowing manufacturers to request meetings with the agency for feedback on proposed clinical investigation protocols and related issues. According to a new Health Canada notice, the pilot for its Pre-Clinical Meeting program will begin in November 2018 and run until March 2019.
Sales of automotive are expected to decline towards year-end as the market naturalises with the reintroduction of the Sales and Services Tax (SST) on Sept 1. RHB Research Institute Sdn Bhd head of Malaysia research Alexander Chia told The Malaysian Reserve (TMR) that the three-month tax holiday period prior to the implementation of SST saw passenger vehicle sales surge as customers took advantage of the cheaper prices and had made advanced buying.
The Malaysian Medical Device Authority (MDA) is adding a three-year transition period for compliance to new medical device labeling rules. According to an MDA circular letter, the regulator had originally set a two-year transition period starting in 2016; that deadline is now extended to 2021.
Primary Industries Minister Teresa Kok said imposing import taxes on select cooking oils and rubber products is among suggestions from the industry stakeholders for Budget 2019. She said the ministry had received 119 proposals to date. The government is expected to table Budget 2019 in Parliament on November 2.
US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency's 2019 fiscal year at a much slighter rate than for 2018.
Malaysia's newly-elected Prime Minister, Mahathir Mohamad, said his government was considering introducing new restrictions on car imports to help nurture the country's "infant" domestic automotive industry. The statement was made at the government's House of Representatives (Dewan Rakyat) on Monday and followed remarks Mahathir made in June, soon after his re-election, that he was considering establishing a new national car programme in response to the sale last year of a strategic stake in Proton Holdings to China's Zhejiang Geely Holdings Group (owner of Volvo and London Taxis).
The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements. According to the MDCO, CFDA now accepts two types of certificates issued to Hong Kong-based manufactures applying for market authorization in China as evidence of home-market approval.
The Chinese government has issued draft changes to the country's medical device regulatory framework that would allow easier market access for foreign manufacturers. The China Ministry of Justice issued a notification (link in Chinese) for modification of Order No. 650, with broad implications for Chinese medical device market registrants upon implementation. The draft changes to Order No. 650 cover issues including product test reporting requirements, home-country approval certifications, clinical evaluation reports (CER) and Unique Device Identification (UDI).
Malaysia remains a key market for Mercedes-Benz in Southeast Asia, with sales of a record 12,045 units last year, nearly twice as many as Singapore, the next best market. The number of units sold by Mercedes-Benz Malaysia Sdn Bhd (MBM) last year was a 2.3% increase over the previous year. Mercedes-Benz sold 6,227 vehicles in Singapore and 3,386 in Indonesia.
Malaysia's manufacturing sector saw its sales value grow 4.9 per cent to RM62.3 billion year-on-year in February, said the Department of Statistics today. This was due to the increase in electrical and electronic products (5.7 per cent), petroleum, chemical, rubber and plastic products (6.6 per cent) and non-metallic mineral products, basic metal and fabricated metal products (5.1 per cent).
The Trump administration recently released a list of about 1,300 goods from China which they might impose a further 25% import duty on. The goods include tyres, conveyor belts and some types of rubber. These tariffs are part of the U.S. response to a Section 301 investigation which concluded that China is coercing U.S. companies into transferring their technology and intellectual property to Chinese enterprises.
Malaysia's exports of rubber products reached RM21.7 billion in 2017, compared to RM18.2 billion in 2016. This is an increase of 19.2 %. The Malaysian Rubber Export Promotion Council (MREPC) said the stellar growth was despite the strengthening ringgit against the US dollar, which translated into lower revenue in ringgit terms.
Glovemaker Kossan Rubber Industries Bhd said that its new factory - known as Plant 16 - will underpin the company's growth this year. The factory in Jalan Meru will add three billion pieces of gloves a year to its production, boosting the group's capacity to 25 billion pieces a year.
Given the strong export performance in 2017, Malaysia is expected to continue dominating the world market for rubber gloves, especially medical gloves, for use in the healthcare sector. Minister of Plantation Industries and Commodities, Datuk Seri Mah Siew Keong said the industry is confident of achieving the target of securing at least 65 per cent of global exports of rubber gloves in 2020. â€œIn 2017, global exports of rubber gloves were estimated at 228 billion pieces and is projected to reach 287 billion by 2020,â€ he said in a statement today.