Gain market access in Malaysia with MDB approval and certification

Whilst the medical devices industry in Malaysia enjoys consistent growth over the past few years, many in the industry recognize that the Medical Device Act 2012 (Act 737) will further improve export quality of medical devices from Malaysia thus driving further growth across the country and region. This means that all medical device players in Malaysia now have to comply with the Regulation by registering their medical devices and obtaining an establishment license to import and distribute medical devices locally in Malaysia.

The regulation of medical devices in Malaysia is carried out by the regulatory authority called Medical Devices Bureau (MDB), Ministry of Health. Parts of the execution and surveillance of a regulation task of the regulatory authority may be delegated to reliable private bodies called CABs. These CABs need to be designated and within surveillance of the regulatory authority. BSI has been designated as capable of assessing to both  QMS ISO 13485 and Good Distribution Practices for Medical Devices (GDPMD).

Working with a CAB is essential for any medical device organization to register their medical device products, be certified to a medical device quality management system (QMS) or to attain certification for their GDPMD.

Medical devices are registered and categorised by class or risk as shown below, including some examples of each class:

• A Simple - Low risk, surgical instruments, tongue depressor, liquid in glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes and walking aids.
• B Low – Moderate risk, hypodermic needles, suction equipment, anaesthetic breathing circuits, aspirator, external bone growth stimulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit and X-ray films.
• C Moderate – High risk , lung ventilator, orthopaedic implants, baby incubator, blood oxygenator, blood bags, deep wound dressing, defibrillator, radiological therapy equipment and ventilators
• D High risk, Pacemakers & their leads, implantable defibrillators, implantable infusion pumps, heart valves, neurological catheters, vascular prostheses & stents.

Please note: As of April 2016, Class A devices are exempt from conformity assessment in Malaysia. However, they must be registered with the MDA, and must continue to meet a number of other requirements, including post-market obligations.

There are three main stages for medical device registration which are outlined below.

Stage One: Pre-Market - the manufacturer is responsible for:

• Ensuring their products conform to the GHTF recommendations of Essential Principles of Safety & Performance of Medical Devices (EPSP).
• Establish an appropriate/approved quality system for manufacturing their products.
• Collect evidence of conformity.
• The approved CAB will verify the evidence provided.

Stage Two: Placement on Market

• Manufacturers or local authorised representatives (LARs) of manufacturers apply to register medical devices and establishment licenses.
• Importers and distributors are required to apply for an establishment license to import/distribute medical devices. Both must also ensure compliance to Good Distribution Practice & advertising requirements.

Stage Three: Post Market

• Establishments are required to monitor safety and performance of products and also carry out other post-market obligations including handling complaints, recalls and the GHTF recommendations – Medical Devices Post Market Surveillance: Content of Field Safety Notices.
• Users of medical devices are expected to use, maintain and dispose medical devices appropriately.
• Users of certain designated medical devices will need to apply for a permit to use and perate these products.

BSI has been approved and registered as a CAB by the Medical Devices Bureau (MDB). In this role, BSI will be responsible for independently assessing medical device manufacturers, importers and distributors to ensure that they comply with the Medical Devices Act 2012. Depending on the classification of medical device, the act requires processes comprising:

• Conducting a medical devices approval review which is necessary prior to registering the device[s] with the Medical Devices Bureau
• Assessing the organization’s medical device Quality Management System, normally compliance to ISO 13485
• Assessing to the Good Distribution Practice for Medical Devices (GDPMD) in accordance to the regulatory compliance set by the Medical Device Bureau for post-market surveillance

BSI is currently registered to assess Quality Management Systems to ISO 13485, and Good Distribution Practice for Medical Devices.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: