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1 Top Glove: Measures in place to prevent excessive OT New 14-12-2018 14-12-2018 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. View
2 Canada's MDSAP Transition Deadline Fast Approaching New 14-12-2018 14-12-2018 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. View
3 Further Operation Efficiency Expected for Kossan Archieved 07-12-2018 06-12-2018 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. View
4 Top Rubber Producers to Meet amid Low Prices Archieved 07-12-2018 06-12-2018 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. View
5 Malaysian Medical Devices Companies Well Received at MEDICA Dusseldorf 2018 Archieved 30-11-2018 03-12-2018 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. View
6 Comfort Gloves Products Taken off US Import Alert List Archieved 30-11-2018 03-12-2018 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. View
7 Glove Manufacturers Could Continue Hot Streak Archieved 23-11-2018 23-11-2018 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 Harta­lega Holdings Bhd, Top Glove Corp Bhd, Kossan Rubber Industries Bhd and Supermax Corp Bhd over the past year has been a whopping 65.2%. View
8 Draft Brexit Agreement's Implications for Medical Device Sector Archieved 23-11-2018 23-11-2018 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). View
9 Malaysian Regulators Launch New Medical Device Databases Archieved 16-11-2018 16-11-2018 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. View
10 Rubber City Project to Restart Next Year Archieved 16-11-2018 16-11-2018 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. View
11 No Rubber Floor Pricing, Says Primary Industries Ministry Archieved 09-11-2018 09-11-2018 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. View
12 Halfway to the New European Medevice Regulation, U.S. Manufacturers Feel the Pinch Archieved 09-11-2018 09-11-2018 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. View
13 South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016 Archieved 29-10-2018 29-10-2018 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. View
14 Southeast Asia Seeks Ways to Protect Car Industry Archieved 29-10-2018 29-10-2018 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. View
15 Top Glove Expected to Add Manufacturing Facilities to Boost Capacity Archieved 19-10-2018 19-10-2018 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. View
16 US FDA Clarifies Human Subject Requirements for Clinical Investigations Archieved 19-10-2018 19-10-2018 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 View
17 Top Glove Q4 Net Profit at RM101 Mil, Dividend 10 Sen a Share Archieved 12-10-2018 12-10-2018 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. View
18 Branding in Automotive Industry Archieved 12-10-2018 12-10-2018 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). View
19 Robust Sales Volume Growth Expected for Hartalega Archieved 05-10-2018 05-10-2018 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. View
20 US FDA Launches Pilot to Expand Special 510(k) Market Pathway Archieved 05-10-2018 05-10-2018 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. View
21 Ministry to Mount Palm Oil and Rubber Mission to North Africa, Colombia Archieved 28-09-2018 27-09-2018 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. View
22 Third National Car to Gear Auto Industry for Next Growth Phase: MAI Archieved 28-09-2018 27-09-2018 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. View
23 Rubber to Surpass Palm Oil Contribution to Economy Archieved 21-09-2018 20-09-2018 The rubber industry is expected to become the number one commodity contributor to the the country's economy as palm oil is facing difficulties in the international market, said Primary Industries Minister Teresa Kok Suh Sim. She said in terms of commodity export earnings, rubber and rubber products were currently the second largest contributor after palm oil. "In 2017, export earnings from rubber and rubber products contributed RM32.1 billion to national exports, (up by 30.2 per cent from 2016). View
24 Malaysia: R&D Can Make Rubber, Coconut Great Again Archieved 21-09-2018 20-09-2018 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. View
25 Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers Archieved 14-09-2018 18-09-2018 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. View
26 Vehicle Sales Expected to Decrease in Adjustment to SST Archieved 14-09-2018 18-09-2018 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. View
27 Dr M-Rubber Innovation Must Go On Archieved 07-09-2018 06-09-2018 Prime Minister Tun Dr Mahathir has urged the rubber industry to carry on with their research in product development to raise global usage of this commodity supplied by many small farmers in Malaysia. He assured that government agencies will firmly support the private sector under the Malaysia Incorporated initiative. "Today, doctors cannot imagine performing surgery without donning on medical gloves. And we see rubber gloves are increasingly being used in other sectors, such as food handling and cleaning services," he said. View
28 Malaysia Must Emulate Success of Rubber, Oil Palm with Other Plants (NST TV) Archieved 07-09-2018 06-09-2018 Malaysia should conduct research for plants that can be nurtured and grown to become successful industries, similar to palm oil and rubber, said Prime Minister Tun Dr Mahathir Mohamad. He said oil palm and rubber trees came from foreign countries, but were developed in Malaysia to become the nation's major export commodities. View
29 Supermax's 4Q Net Profit Jumps 84% on Higher Sale Archieved 31-08-2018 30-08-2018 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. View
30 Europe Update: Notified Body MDD, AIMDD Timelines Archieved 31-08-2018 30-08-2018 Some European Notified Bodies appear to have set early 2020 deadlines for winding down renewals of CE Mark certifications under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). Manufacturers may find it increasingly difficult to obtain MDD and AIMDD certifications starting in late 2019. These timelines should help manufacturers plan their transition strategies for Medical Devices Regulation (MDR) compliance. Some Notified Bodies (NBs) will soon be designated to the Medical Devices Regulation (EU) 2017/745 (MDR). But how they will manage their Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) reviews concurrently with their MDR reviews is yet to be revealed. View
31 New Gloves to Account for 10% of Hartalega's Export Volume Archieved 17-08-2018 17-08-2018 Hartalega Holdings Bhd expects its newly-created antimicrobial gloves (AMG) to account for 10% of its export volume in the first year from the launch of the product in May. Group managing director Kuan Mun Leong revealed that the shipment of the AMG would begin next month, following the securement of an order from a major pharmaceutical company in Germany. View
32 June Natural Rubber Output Up 16.3% Archieved 17-08-2018 17-08-2018 Malaysia's natural rubber production in June 2018 increased by 16.3% to 41,578 tonnes from 35,761 tonnes in the previous month, according to Department of Statistics. For year-on-year, the production decreased by 17.9%, it said in a statement today. It said the average price of latex concentrate was recorded at 439.83 sen per kilogramme (kg) whereas the average price of Standard Malaysian Rubber 20 was 545.2 sen per kg, both diminished at 9.7% and 2.8% respectively from May 2018. View
33 Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline Archieved 10-08-2018 10-08-2018 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. View
34 Malaysia: Proposal to Tax Imported Cooking Oils and Rubber Products Archieved 10-08-2018 10-08-2018 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. View
35 US FDA Medical Device User Fees Tick Up Slightly for 2019 Archieved 03-08-2018 06-08-2018 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. View
36 Malaysia Considering Restrictions on Auto Imports Archieved 03-08-2018 06-08-2018 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). View
37 China FDA Eases Country-of-Origin Requirements for Hong Kong-based Medical Device Registrants Archieved 20-07-2018 20-07-2018 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. View
38 Changes to Chinese Medical Device Regulations Would Benefit Foreign Manufacturers Archieved 13-07-2018 13-07-2018 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). View
39 Malaysia Remains a Key Market for Mercedes-Benz Archieved 27-04-2018 27-04-2018 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. View
40 Malaysia's Manufacturing Sales Grew 4.9 Percent to RM62.3 Billion in February Archieved 13-04-2018 13-04-2018 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). View
41 Rubber, Tyres and Conveyor Belts among Goods Affected by Further Tariff by the Trump Administration Archieved 13-04-2018 13-04-2018 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. View
42 Malaysia's Rubber Products Export Reached RM21.7 billion in 2017 Archieved 09-03-2018 09-03-2018 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. View
43 New Factory will Support Company's Growth - Kossan Rubber Industries Berhad Archieved 02-03-2018 02-03-2018 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. View
44 Malaysia to Continue Domination of World Rubber Gloves Market Archieved 23-02-2018 23-02-2018 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. “In 2017, global exports of rubber gloves were estimated at 228 billion pieces and is projected to reach 287 billion by 2020,” he said in a statement today. View