Malaysian Medical Device Authority Issues Draft Incident Reporting Structure

Hairel Abbie - 26-nov.-2015 04:17:13
  Malaysia’s Medical Device Authority, a division of the Malaysian Ministry of Health, has just issued a first edition of a draft guidance document (MDA/GD/0014) on Mandatory Problem Reporting for medical devices. The guidance document relates to medical devices (but not those in clinical investigations) and IVDs; establishments; and users and others concerned with the continuing safety of medical devices. The MDA is encouraging a no-blame culture and says the act of reporting an incident to the authority is not to be construed as an admission of liability for the incident and its consequences. The proposed timelines for problem reporting are as follows: Type of incident   Timeframe in which incident has to be reported   For incidents that represent a serious threat to public health   48 hours   For incidents that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person   10 days   For incidents where a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person   30 days   After that, medical establishments are to follow up with a final report within 30 days of the initial reports or within a timeframe as allowed by the MDA, detailing the investigation into the incident and the outcome. Familiar Terms Familiar terms within the context of international harmonization efforts in the field of device reporting are recognized in Malaysia and explained in the guidance document. These terms include: field corrective action and field safety notice, indirect harm, final reports and trend reporting. The authority will also sometimes agree periodic follow-up reporting with manufacturers or authorized representatives for certain types of device and incident, although with trigger points if certain levels are exceeded. As a general principle, there should be a pre-disposition to report, rather than not. Moreover, any incident, which meets the three basic reporting criteria listed below, is considered as reportable: a) an incident has occurred; b) the medical device is associated with the incident; and c) the incident led to one of the following outcomes; i) a serious threat to public health; ii) death of a patient, user or other person; iii) serious deterioration in state of health, user or other person; or iv) no death or serious injury occurred but the incident might lead to death or serious injury of a patient, user or other person if the incident recurs. The draft guidance document states that in assessing the link between the device and the incident the manufacturer should take account of the opinion, based on available evidence, of healthcare professionals; the results of the manufacturer’s own preliminary assessment of the incident: evidence of previous, similar incidents; and other evidence held by the manufacturer. It states that this judgement may be difficult when there are multiple devices and drugs involved. In complex situations, it should be assumed that the device may have caused or contributed to the incident, the draft states. The MDA considers it would want to be notified where: an incident associated with a medical device happened, and, if it occurred again, it might lead to death or serious deterioration in health; or testing, examination of the medical device, information supplied with the medical device, or any scientific literature indicated some factor (eg deterioration in characteristics or performance, or a shortcoming in the information) which could lead to an incident involving death or serious deterioration in health. The MDA also points out that where companies merge or buy each other out and the vigilance and other post-market surveillance obligations are being transferred to another legal entity, it is important that post-market surveillance and vigilance activities continue and that the MDA is appraised of the implications and provided with new contact details as soon as possible IVDs And Further Information In the case of IVDs, the type of incidents that should be reported include: misdiagnosis; delayed diagnosis; delayed treatment; inappropriate treatment; and transfusion of inappropriate materials. In addition, the MDA indicates in its draft that: where an incident occurs as a consequence of the combined use of two or more separate devices (and/or accessories) made by different manufacturers, each manufacturer or authorised representative should submit a report to the MDA; manufacturers should keep their conformity assessment body (CAB) advised of issues occurring in the post production phase which may affect the certification. This would include relevant changes derived from the vigilance system. The draft guidance document, which fits within the framework of Malaysia’s 2012 Medical Device Act, and will remain relevant within the context of the country’s forthcoming Medical Device Regulation, gives a series of examples where reporting is not required, including use error reports. Source : Clinica  

French aeronautical industry set for new heights as global demand skyrockets

Harold MEURISSE - 07-janv.-2015 04:18:31
Airbus, headquartered in the French city of Toulouse, projects that the global number of in service passenger aircrafts will double by 2033, to 31,400. The usual suspects can explain this rise in demand: change in demographics in developing economies, and tastes and preferences of their emerging middle class. Who will benefit from this near certain doubling of the market? Certainly one of the strongest cases comes from Airbus and the rest of the 3,000 French companies working in the field of aerospace.   More than Airbus   The European aviation industry, the production, maintenance and support of civil aircraft, is currently second largest in the world following the US’s Boeing led sector. It is undeniably integral to France in producing jobs and growth, as it is the largest foreign looking sector with 22 billion euros in net exports. Many SMEs depend and service Airbus and these will directly benefit from the impending expansion of the giant’s aircraft deliveries, as for the A320 for example, rising from 42 to the target of 50 planes per month.   Aside Airbus’s presence, there are many smaller companies that have succeeded independently and are capturing attention abroad. For example, Mapaero produces paint for airplane interiors and exteriors, such as for aircraft’s wheels. They rapidly acquire new airlines as clients, the company being particularly innovative as its products are in line with recent EU regulations restricting chemicals in paint. The company’s attempts to limit impact on environment will also secure it a bright future.   Ready for Take Off   The French aviation industry is currently well diversified, mature and a world leader. What are its prospects for the future? It seems hard for things to get better, but it certainly looks this way. Brice Robin, Ubifrance’s project head explains that the industry is not lingering on its current successes: “Yes, over the last 100 years France has a history with aviation. This however is never enough, and we have to look to innovation for the future. For example French companies spend an average of 14% of their revenues on R&D.”   Innovation is incredibly important for France to extend its advantage in a market that requires the utmost quality in order to ensure the security and longevity of its very expensive products to its prospective clients. Mr. Robin adds that there is an industry pressure for firms to “deliver faster, perfect parts with high level of quality, and better products with new technology, such as lower weight.”   There are competitors arising in developing markets such as Brazil, China and Russia. However, they are likely to have difficulty in competing with France’s knowhow and completeness of services. Mr. Robin explains, as an example, that the French maintenance’s market provides a one-stop shop for clients and this reduces costs as well as being convenient: “Today buyers don’t only look at the cost of aircraft, but also the maintenance and all else surrounding the aircraft since they will keep the aircraft for 25 to 35 years. They will also be renovating the aircraft interior every 5 to 10 years.” An airline doing business in France will not only purchase from Airbus but also look to other French companies, some located as near as the Toulouse metropolitan area, that provide maintenance and other support in usage such as refurbishment.    Mr. Robin puts this all in perspective of the emerging competition of the French industry: “Clients cannot supply all of their parts and components from a new player in an emerging market because some technologies, materials, designs, and new processes there will not be available and this is a French advantage.“ For example, for the maintenance of certain structural parts that are produced by Airbus, there is a requirement of special certification that can only be found amongst French engineers.   Ubifrance and French SMEs   Ubifrance helps French companies find clients and partners abroad. For example, Win MS participated with Ubifrance at trade shows in Dubai and was able to attain contacts with local airlines. Their aeronautical maintenance equipment were very impressive to Qatar Air, world’s second most preferred airline according to the World Airline Awards.    Aeroform provides repairing equipment for composite materials, much of which can be found in the structure of modern aircrafts. The company was looking for one distributor in Spain and Germany, and with help of Ubifrance was able to attain a list of seven to ten possible suitors in each of the markets. In three months they signed one distributor in each country and are now working with Ubifrance to achieve the same results in the Russian market.     For further information about French exporting companies, please go to:   Airbus: http //     Aeroform :   Mapaero :  

POLLUTEC 2014 : 26th international exhibition of environmental equipments technologies and services

Harold MEURISSE - 17-nov.-2014 03:21:25
Show presentation Leading general show for the environment and energy industries. Pollutec brings together professionals from around the world to discuss innovative solutions that reduce the impact of human activities on the environment, whether it be in industry, local authorities or in the service sector. • 100 000 sq.m exhibition space • 65 000 trade visitors • 2 200 exhibitors • 400 conferences • 200 innovations premiered • 8 sectors • 3 focus Partners villages Hosted in partnership with a professional organization, the villages and expertise clusters bring together in a common dedicated area companies specializing in a specific field.Recyclage ASBESTOS • Meet professionals of asbestos removal and review the latest developments about regulations and eradication industries. • Organized in partnership with Réso A+ SPACE APPLICATIONS • Organizations promoting the use of space for the environment are shining the spotlight on the numerous advantages that space technologies • offer for the implementation of sustainable development. ECOTECH NETWORK • The Network will be highlighting the advances in shared research works. • In partnership with the competitiveness clusters of the Ecotech network (network of eco-technology competitiveness clusters).   TRENCHLESS TECHNOLOGIES • This area will feature products and services for the inspection and renovation of existing networks. • In partnership with the French scientific association for trench-free technologies (FSTT). SITES AND SOILS • Pollutec Horizons is shining the spotlight on the current technical and regulatory situation in the soil remediation business. • In partnership with the UPDS. ENGINEERING EXPERTISE • Meet engineering practices and design offices specializing in environmental engineering. More information : • Official website • Vivapolis : powered by French creativity To meet French companies at the French Pavillon: • •  

Visit from JAKIM’s Halal Hub Division to UBIFRANCE Malaysia

Rafizah MAZLAN - 20-févr.-2014 04:21:41
On the 7th of February 2014, the UBIFRANCE Kuala Lumpur office was honored to welcome a delegation from the Department of Islam Development Malaysia (JAKIM) - Halal Hub Division. The delegation consisted of two officials,  Mr Mohd Suhaimi Yusoff, Senior Assitant Director and Mrs. Wahidah Noorshikin Jamaruddin Assistant Director of Hub Halal Dvision. An information session on the Malaysian Halal regulations was held during this visit, whereby a presentation on Halal and various functions of JAKIM’s Halal Hub Divsion was given to the Trade Advisors at UBIFRANCE. They also shed some light on the processes involved in obtaining the Halal certification, as well as related issues and case studies. The visit was a successful exercise in strengthening the bilateral relations between France and Malaysia. Please contact for futher information. 

All new Peugeot 2008 Urban SUV introduced in Malaysia

Rafizah MAZLAN - 10-janv.-2014 09:07:06
The first new car of 2014 comes from Nasim Sdn Bhd, the official distributor for the Peugeot brand here, in the form of the Peugeot 2008, under a new term which has surfaced quite recently, the Urban SUV. The All-New Peugeot 2008 Urban SUV was first previewed at the Kuala Lumpur International Motor Show 2013 (KLIMS) and has so far received more than 100 bookings. The All-New 2008 Urban SUV comes with six airbags and an Electronic Stability Programme (ESP) that combines several functions: anti-skid regulation (ASR), dynamic stability control (DSC), anti-lock braking system (ABS), emergency braking assistance (EBA) and electronic brake force distribution (EBFD). Additional safety features consists of front and rear parking aid with audio visual assistance, hill start assist, very high strength steel (VHSS) body structure, cornering assist fog lamp and ISOFIX anchorage points at rear. As a result, the All-New 2008 Urban SUV achieved a full five-star rating from EURO NCAP. Among the awards won by the All-New 2008 Urban SUV include the ‘European Car Of The Year 2014’ by Italy’s Auto Europa, and ‘Top SUV/Crossover Vehicle’ by Poland’s Golden Steering Wheel awards. The on-the-road price with insurance for the All-New 2008 Urban SUV is RM119,888 in Peninsular Malaysia while in Sabah the on-the-road price with insurance is RM121,888 and in Sarawak the on-the-road price with insurance is RM121,588.  Source: The Malay Mail Online

Meeting between MCMC & ARCEP at Telecom World 2011 conference in Geneva

Juliette MALLEZ - 27-oct.-2011 04:13:58
 Boasting the largest display booth at the International Telecommunications Union (ITU) Telecom World 2011 conference, Malaysia is showcasing its technological achievements in terms of broadband and connectivity. “The launch of the Malaysian pavilion is a great leap for the country, in terms of putting us on the world map, highlighting our achievements in terms of telecommunications and also other aspects in the technology field,” said Information, Communication and Culture minister Datuk Seri Dr Rais Yatim on Tuesday. This is the third time Malaysia is attending the Telecom World, featuring homegrown companies like TM, Maxis, Celcom, MSC and Measat. At least 250 world leaders ranging from heads of state and officials, city mayors, telco industry CEOs and technology gurus, of which will lead their own contingent of experts are expected to attend this year’s conference held in the land of neutrality, Switzerland. While global technological giants along the likes of Huawei Technologies Co., Alcatel-Lucent, Cisco, Ericsson, Fujitsu, Intel, NTT Group, NTT DoCoMo, Qtel, RIM, Satorys, Swisscom, Telkom SA, Turk Telecom, TDIA, and ZTE also came in force to mark their presence. This presence was also an opportunity for UBIFRANCE Malaysia to introduce the Malaysian Communications And Multimedia Commission (MCMC) with ARCEP, the French Regulatory Authority. This meeting was very informative and we hope it will be the beginning of a long and fruitful collaboration between our two countries.

Bureau Veritas acquired Scientige Sdn Bhd

Magali Voisin-Ratelle - 22-sept.-2011 11:49:38
In with EPP 8 within the Oil, Gas and Energy NKEA, Bureau Veritas recently acquired Scientige Sdn Bhd, a company based in Malaysia specialising in asset integrity management services. This acquisition is part of developing capabilities and capacity through strategic partnership and joint ventures for this NKEA. Bureau Veritas is a global leader in conformity assessment and certification services. The Group has around 48,000 employees in more than 900 offices and 330 laboratories located in 140 countries. Bureau Veritas helps its clients to improve their performances by offering innovative services and solutions to ensure their assets, products, infrastructures, and processes meet standards and regulations in terms of quality, health and safety, environmental protection, and social responsibility.   Headquartered in Kuala Lumpur, Scientige Sdn Bhd specialises in providing asset integrity management and risk and safety related services to oil and gas companies operating in Malaysia. It employs a multi-disciplinary team of 80 people and generated revenue of €5 million in 2010.   Through this strategic acquisition, Bureau Veritas will strengthen its local presence by enhancing technology and knowledge transfers as well as expediting the level of in-house competency. The new organisation will serve as the heart of the technical operations in the South East Asia region, providing services to Singapore, Thailand, Vietnam, Brunei and Indonesia.   In addition, close working relationships will be fostered with the other Bureau Veritas centres of excellence (or technical centres) in Australia, China and Middle East. This complements its mutual interest with Petronas as the national oil company ventures into Australia, Middle East and Central Asia. Investment RM24 million GNI Impact RM111 million by 2016 Jobs created 550
Welcome to the French Trade Commission – Business France office in Malaysia! “Business France is the national agency supporting the international development of the French economy, responsible for fostering export growth by French businesses, as well as promoting and facilitating international investment in France. It promotes France’s companies, business image and nationwide attractiveness as an investment location, and also runs the VIE international internship program. Founded on January 1, 2015 through a merger between UBIFRANCE and the Invest in France Agency, Business France has 1,500 personnel, both in France and in 70 countries throughout the world, who work with a network of public- and private-sector partners.” As a member of the French diplomatic network in Malaysia, Business France’s three missions are: - Fostering export growth by French businesses. - Promoting and facilitating international investment in France.


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