Gain market access in Malaysia with MDB certification

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 simulators, 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 - 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 operate these products.