Monthly Archives: February 2019

The Ministry of Health in Vietnam has implemented new regulations for medical device registration. The new decree (169/2018/ND-CP) issued on 31 December 2018 describes the amends made to supplement Decree 36/2016/ND-CP on the management of medical devices.

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Thailand is one of the most popular medical tourism destinations in the world. Healthcare professionals and facilities in Thailand are known for providing excellent service in various disciplines such as plastic and reconstructive surgery, orthopedic surgery, cardiac surgery, and dental care.

The Thai government wants to make Thailand a leading destination for pharmaceuticals and medical devices and a world-class provider of medical care, including medical tourism.

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In November 2018, the Health Services Authority (HSA) Singapore released an update to the Medical Device Registration Dossier guidance documents GN17 & GN18 (Guidance for Preparation of Submission for General Medical Devices and In Vitro Diagnostic Medical Devices using the ASEAN CSDT) following industry feedback that the previous versions were too complex and lacked clarity.

The Health Services Authority (HSA) Singapore has revised current Medical Device Registration Dossier guidance documents following industry feedback that they were too technical, complicated and lacked clarity. After much deliberation, the HSA released revamped versions of the documents, that are simple, salient, brief and clearly expressed.

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