Asean Agreement On Medical Device Directive (Amdd)

The Malaysian Ministry of Health manages the country`s health affairs. Under the Ministry of Health, the Medical Device Authority is the government organization responsible for monitoring prescriptions for medical devices in Malaysia. The laws governing the production and distribution of medical devices in Malaysia are the Medical Devices Act, the Medical Device Authority Act and the Medical Device Regulations, all of which were published in 2012. You can find more information and free resources on Asian medical and pharmaceutical products as well as healthcare markets in our resource center and blog. Not fully implemented. The recent important legislation, The Medicines and Medical Devices Act No. 07/NA, issued in 2012, is in accordance with the AMDD. Under this law, companies that register their medical devices in Laos will comply with the ASEAN medical device classification and will follow the CSDT format in the application. Not implemented yet. Currently, laws and guidelines on medical devices are still being developed by the government. There is an aO project in the works for the implementation of this year 2018. Details of the chronology and integration of amDD have not yet been finalized.

In the current landscape, producers wishing to market medical devices in Brunei should only correspond to the Ministry of Finance and the Royal Customs and Excise Administration (RCED) in Brunei to obtain a business registration number and customs clearance. Partially implemented. Currently, DDF classifies medical devices into 4 categories: Class A, B, C and D according to ASEAN guidelines and integrates CSDT elements into the registration documentation. The registration of Class A medical devices requires FSC from the country of origin, ISO certificate 13485 and letter of authorization for importers. For B-D classes, technical requirements in CSDT format and a summary of submission tests are required. Other key elements of ASEAN`s AMDD are still in favour of integration. In August 2014, the Association of Southeast Asian Nations (ASEAN) signed a formal agreement that harmonizes the rules on medical devices. This agreement was officially called the ASEAN Medical Devices Directive (AMDD). It offers an easy way to access the medical device manufacturers market. The Vietnamese Ministry of Health adopts the rules and regulations governing medical devices and medicines. The Department of Medical Equipment and Health Works is the subsection of the Ministry of Health, responsible for monitoring the registration and authorization of medical devices in Vietnam, while the Medicines Administration Agency controls the drugs. Some medical devices using new technologies may also be asked to transmit information to the Ministry of Science and Technology.

For more information on regulatory requirements and the registration process for medical devices and medicines in Malaysia, see the registration of medical devices in Malaysia and the registration of drugs and API products in Asia.

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