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
Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of
On 13 July 2023, The Ministry of Communication and Informatics (Kominfo) issued a draft regulation concerning Technical Standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices. The proposed guidelines will revoke several regulations including SDPPI regulation no 161 Year 2019, the main reference in the registration of Short-Range Devices
In the interest of consumer protection and to ensure the quality, efficiency, and safety of medical device production, the Thai FDA released a draft public health announcement and guideline to establish a quality system for producing medical devices on 19 July 2023. Should the final announcement and guideline be approved
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
