The Ministry of Health (MoH) of Malaysia has initiated various efforts to combat HIV/AIDS infection in the country ever since the first detected case in 1986. One of which is by introducing an HIV self-testing (HIVST) as a pivotal method for Test and Treat HIV/AIDS. This initiative aims to encourage
The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1. Scope: Applies to all products that fall within the definition of medical device,
The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows: Scope: To determine the wearable products that fall within the definition of medical device as stipulated in
The Health Sciences Authority (HSA) of Singapore has revised guidance documents and templates pertaining to medical device product registrations. The key updates are as follows: Apart from requirements of registration under Health Products Act, local supply and use must comply with other legislations such as Private Hospitals and Medical Clinics
The Ministry of Health of Vietnam issued several new regulations that took effect from July 1st, 2023. The following is the summary of how the regulations may have affected the provision of medical devices in the Vietnamese Market. Circular No. 14/2023/TT-BYT stipulated the order and procedures for formulating bidding packages
The Health Sciences Authority of Singapore (HSA) has revised the GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices as of 31 July 2023. This guidance will be applicable to any entity who performs manufacturing, importing, and supplying by wholesale of the medical devices. The following are
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