Malaysia’s Ministry of Health (MOH) has been working for several years on gradually establishing a medical device registration system. In February 2005, they announced the Medical Device Voluntary Establishment Registration program, abbreviated MeDVER. Implemented in January 2006, this is a system where medical device companies can voluntarily register lists of their devices (not registering devices individually).
To establish MeDVER more fully in the near future, the MOH has recently drafted a proposed medical device regulatory system. The proposal encompasses the monitoring and supervision of medical devices from the pre-marketing to post-marketing stage. This medical device regulatory system would strive for global harmonization.
Medical devices would be divided into four risk classes. 16 rules would be used to determine the risk class of the medical device.
All phases of the medical device would be monitored, from design and development to adverse event reporting. Pre-market review would involve safety and performance checks in addition to checking compliance with labeling requirements.
Product registration would be required for all medical devices except those classified as low-risk (Class A). The MOH has listed three possible options for demonstrating the safety, effectiveness, and quality of a medical device. These options include regulatory approval from the US, EU, Australia, Canada, and Japan, submission of a certificate issued by a conformity assessment body, or submission of technical documentation and clinical data for assessment.
Class A products would only require a notification without a pre-market assessment. Manufacturers would need to maintain and let the Ministry know of the list of Class A products they have placed into the market.
All local manufacturers who manufacture or re-package devices sold in Malaysia will need to be licensed. Manufacturers will be required to perform post-market surveillance and adverse event reporting. Manufacturers must also establish a system to collect post-market surveillance data of high-risk medical devices to receive product approval and ensure product safety.
Local representatives (of imported Class B or higher devices) must also be registered, and can be any private company appointed to represent the manufacturer.
Quality systems will also be required, though the MOH has not decided the specifics on the structure. Audits, either by the government or third party agencies, may occur to review the quality system and ensure product quality.
The currently operating MeDVER allows online registration at www.medicaldevices.gov.my.