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1 Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers New 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
2 Vehicle Sales Expected to Decrease in Adjustment to SST New 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
3 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
4 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
5 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
6 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
7 Joint Statement by Governments of China and Malaysia on Bilateral Ties Archieved 24-08-2018 27-08-2018 China and Malaysia are optimistic about the prospect of their bilateral relations. According to a joint statement between the two governments on Monday, both sides will adopt a strategic and long-term vision, and work for the sustained and steady development of their comprehensive strategic partnership. View
8 China Firms Propose RM41 Billion for Malaysia's Third National Car Project Archieved 24-08-2018 27-08-2018 Two companies from China have proposed to invest US$10bil (RM41bil) in Malaysia's third national car project and build a regional automobile hub to cater for the region in southern Perak, according to official sources. Separately, Zhejiang Geely Holding Group has shown interest to participate in the national car project by upgrading its facilities in Malaysia. View
9 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
10 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
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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