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Medical Device Authority, a division of the Malaysian Ministry of Health, has just issued a first edition of a draft guidance document (MDA/GD/0014) on Mandatory Problem Reporting for medical devices.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  

Meet French exhibitors at the France Pavilion at Arab Health 2016

Hairel Abbie - 26-nov.-2015 03:40:52
  Date begin : 25th january 2015 Date End : 28th january 2015       ARAB HEALTH   will host in 2016 37 country pavilions further enhancing the range of hospital equipment, medical equipment, medical devices and medical technology on display at the exhibition. ARAB HEALTH 2016 will showcase more than 4,000 companies exhibiting their latest innovations to more than 130,000 healthcare professionals attending from 163 countries. MEDLAB is the most influential MEDICAL DIAGNOSTICS event in the Middle East. MEDLAB 2016 will showcase more than 500 companies exhibiting their latest innovations to more than 30,000 healthcare professionals attending from 37 countries.   French companies in the medical sector:   AD REM TECHNOLOGY AIRINSPACE AKS FRANCE (NAUSICAA Medical) ALLIBERT MEDICAL HOLDIPLAST APPLICATIONS TECHNOLOGIQUES AVANCEES - A T A ATELIERS DU HAUT FOREZ Avalun Bertin Technologies BERTIN TECHNOLOGIES BIOLABO SAS BIOTECHNI CARINA CARINA CENTRECO-Centrexport COLDWAY Cosmosoft DELACROIX-CHEVALIER E I H F Ecodas EDAP TMS FRANCE EIHF-ISOFROID ERMEDI INTERNATIONAL EURASANTE FACULTATIEVE TECHNOLOGIES HOLTEX IDEAL MEDICAL PRODUCTS ENGINEERING INNOV SA INTAIR MEDICAL JRI KINETEC SAS Laboratoire De La Mer LID LILLE EURASANTE MATIFAS MEDIFF MEDINOVA INTERNATIONAL Medlane METACONCEPT INTERNATIONAL MICROVAL MILS SAS MULTIWELL ORTHOPAEDIC & SPINE DEVELOPMENT PETERS SURGICAL PHARMAOUEST INDUSTRIES RHODYS ROCAMED FRANCE S.B.M SA SA BIOLABO SANIVAP SATISFORM SCALEO MEDICAL SEFAM SERF SOLSTEO Sonoscanner SPENGLER SAS SPINEWAY STE AGENCINOX TECH MED TM TEKNIMED TESALYS THUASNE TRADING POINT VERRE ET QUARTZ TECHNOLOGIES VILLARD VISIOMED GROUP YSY MEDICAL SAS  

Elle Malaysia celebrates wins at MPA Malaysia Awards 2015

Lyslie Legendre - 05-nov.-2015 08:51:30
The MPA Malaysia Awards, the countrys flagship celebration of the magazine industry received nearly 140 entries this year.   The awards were given out at a ceremony held at Kumpulan Media Karangkraf in Shah Alam. Mongoose Publishing brand ELLE Malaysia claimed two awards yesterday : -           - a silver for Editorial features for State of the Female Nation;   -           - a gold for Front Cover for its June issue featuring Angelina Jolie.

Malaysia’s first floating solar farm installation started at Sungai Labu Water Treatment Plant

Kim Hwa KHOO - 04-nov.-2015 03:19:38
With some 70 lakes found suitable in Peninsular Malaysia for developing floating photovoltaic (PV) systems, Tenaga Nasional Bhd (TNB) has just embarked on its a 108 kWp pilot system in Sg Labu Water Treatment Plant in Silak Tinggi Reservoir, Selangor. The project, which is owned by the Ministry of Energy, Green Technology and Water, is 80% funded by the Malaysian Electricity Supply Industries Trust Account or known by its Malay acronym AAIBE (Akaun Amanah Industri Bekalan Elektrik), while the rest is by TNB. The pilot floating PV systems project commenced in March 2015 and for completion of the study by November 2016. The 432 solar panels installed on the floating platform made from high-density polyethylene (HDPE) will be able to generate the equivalent to the solar energy consumed by 20 houses annually. The very innovative French company Ciel & Terre International is the solar island designer and the patented Hydrelio(c) floats technology provider of TNB Research’s floating solar farm. They have already implemented various large scale solar farms on lakes in Japan, Korea, UK, and Brazil. The others core partners of this R&D project are Singaporean REC Solar Pte. Ltd. which supplies the solar panels, and the local engineering company OGM Sdn. Bhd. which carries out the installation and engineering works. The installation of the floating solar farm is estimated to be completed in November 2015. TNB Research team would then carry out the data collection and energy efficiency analysis based on the solar panels angle and the height between the floating platform and underwater surface. Should the project proves to be successful, TNB will look at how to replicate and promote the initiative in the other lakes. Indeed, the country is expected to achieve the installation of 2000 MW of renewable energy by 2020. Today, the installed capacity of RE is 500 MW.   Point of contact:   Caroline PELAEZ-HUE Business France – French Trade Commission Senior Trade Advisor, Head of Industries, Energy and Cleantech     Harold MEURISSE Ciel et Terre International International Business Manager    

Medica Compamed 2015: Meet French exhibitors at the France Pavilion from 16th to 19th of November

Lyslie Legendre - 03-nov.-2015 04:19:49
COMPAMED takes place in Dusseldorf, Germany and  is the leading international market place for the medical supplier industry and product development! Thus COMPAMED is No. 1 for the medical supplier industry.    More than 750 exhibitors from 40 nations More than 17,000 international trade visitors 11.000 qm floor space COMPAMED takes place in connection with MEDICA, and in this way depicts the complete process chain for medical products More than 4,800 exhibitors at MEDICA are potential visitors of COMPAMED COMPAMED takes place in connection with MEDICA and offers a wide range of technology and service solutions for use in the medical engineering industry – from new materials, components, intermediate products, packaging and services all the way over to more complex order processing (EMS) and nanotechnology. Companies on involved in this event: ·          AD REM TECHNOLOGY ·          ALTEOR ·          AM CUBE ·          AMINOGRAM ·          APHEX BIOCLEAN FRANCE ·          APPLICATIONS TECHNOLOGIQUES AVANCEES - A T A ·          ARTS ENERGY ·          ATELIERS DU HAUT FOREZ ·          Avalun ·          AWEL INTERNATIONAL ·          AXFIL ·          Bertin Technologies ·          BERTIN TECHNOLOGIES ·          BIO EVOLUTION ·          BRETAGNE COMMERCE INTERNATIONAL ·          CAIR LGL ·          CARINA ·          CASTRES- MAZAMET TECHNOPOLE ·          CIR MEDICAL ·          CISBIO BIOASSAYS ·          COLDWAY ·          COMPTOIR GENERAL DU RESSORT ·          CRYONIC MEDICAL ·          DELPHARM BIOTECH ·          DIACLONE ·          Dtamedical ·          E I H F ·          EIHF-ISOFROID ·          ETABLISSEMENTS ASTRA ·          ETABLISSEMENTS DESSILLONS & DUTR ·          EUROCELL DIAGNOSTICS ·          EVOLUCARE TECHNOLOGIES ·          FAVI LE LAITON INJECTE ·          FAVI S.A. ·          FOURES SAS ·          FUMOUZE DIAGNOSTICS ·          GROUPE LEPINE ·          HOLTEX ·          i2a ·          I-CARE CLUSTER ·          ID bio ·          ID bio SAS ·          JCM MED ·          JRI ·          LA DIFFUSION TECHNIQUE FRANCAISE ·          LABORATOIRE DU SOLVIREX ·          Laboratoire PROTECSOM ·          LE GUELLEC ·          LID ·          LOXOS ·          MANUDO MEDICAL ·          MATIFAS ·          MCCB ·          MEDICAL INNOVATION DEVELOPPEMENT ·          MEDICAL PROCESS ·          MEDIFF ·          MEDINOVA INTERNATIONAL ·          MEZIERE IDC ·          MICROVAL ·          MULTIWELL ·          NEOSCAN MEDICAL ·          NG Biotech ·          NOWAK ·          OPTIMIZ ·          PAROLAI ·          PIXIENCE ·          Plastifrance ·          POLIDIS ·          PROGRESS SILICONES S.A.S. ·          QUIES ·          RM INGENIERIE ·          ROVIPHARM ·          SA GALVANOPLASTIE INDUSTRIELLE ·          Saft ·          SAFT ·          SANIVAP ·          SARL JCM MED ·          SATISFORM ·          SILIOS TECHNOLOGIES ·          SKINEXIANS ·          SNEP POLIDIS ·          SOLSTEO ·          SPINEWAY ·          STARVAC GROUP ·          SURGICAL PERSPECTIVE ·          TECHNOFLEX ·          TEKNIMED ·          TERRAILLON ·          TESALYS ·          THUASNE ·          TOP CLEAN PACKAGING GROUP ·          TRIOPLANEX FRANCE SA ·          VALMY SAS ·          VALMY SAS ·          VECTEC ·          VERRE ET QUARTZ TECHNOLOGIES ·          VIGILIO ·          YSY MEDICAL SAS ·          ZEAKON DIAGNOSTICS  

L’Occitane heads to Hautes Alpes in search of spring water/CBN

Lyslie Legendre - 03-nov.-2015 04:10:36
"French cosmetics company L’Occitane en Provence has signed an agreement with the commune of Réotier in the Hautes Alpes region to use thermal spring water from its ‘petrified fountain’ in its skin care products. The water, which filters through layers of dolomite and gypsum is rich in calcium bicarbonate; the water exits the rock at 21°C and then degasses, precipitating the calcium into stalactites. The minerals in the water are known to affect the mechanism of the skin and the company is optimistic that the water will have useful properties for use in its products. Bénédicte Le Bris, Director General of Research and Development at L’Occitane, said: “We will perform formulation tests in the lab for several months to determine the principal actives in this water that could go into creams or shampoos."   The agreement allows L’Occitane to take a maximum of 5,000 litres of water per year over a two-year period. The company has suggested it will take around six years to develop products based on it. “The objective is to be able to use the water while respecting the integrity of the site,” said Jean-Charles Lhommet, in charge of sustainability at L’Occitane. “The use has to be both reasonable and sustainable.” Although the water is of interest in the short-term, Jean-François Gonidec, CEO of LOccitane, said the fountain could represent another business opportunity. “Depending on how the project progresses, we haven’t ruled out building a factory nearby,” he added. It is also hoped the fountain will now become a tourist attraction; L’Occitane is understood to have put aside €12,000 to build a car park with disabled access in anticipation of future visitors." Source :

Airbus sets up customer service centre in Malaysia

Kim Hwa KHOO - 02-nov.-2015 08:06:59
Aircraft manufacturer Airbus has launched officially its RM24mil customer service centre in Sepang, Malaysia on 29th October 2015. Based at its joint-venture maintenance unit Sepang Aircraft Engineering facility, Airbus Customer Service in Malaysia will provide major aircraft engineering and repair design services such as retrofits, modifications, and complex repairs to the their global customers. The centre would provide employment to over 130 skilled local and international engineers and mechanics, including returning talents when fully operational.
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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