Last week the Medical Device Authority (MDA) in Malaysia released a new guidance document on face masks and respirators for medical use. The guidance covers performance characteristics, labelling and registration requirements. According to the World Health Organisation (WHO), medical face masks are divided into two categories: procedure masks and surgical masks, both of
Vietnam’s Ministry of Health recently released a guidance document no. 7395/BYT-TB-CT on preparing medical device registrations. The aim of the document is to help applicants better understand and comply with regulations to speed up the appraisal of registration applications and thereby facilitate the circulation of medical equipment on the market.
The Philippines Food and Drug Administration (FDA) has resumed access to its online Verification Portal which provides comprehensive lists of FDA Licensed Establishments and Registered Health Products. The portal is open access so that the general public can verify whether a medical device placed in the Filipino market is properly licensed and distributed by an
We’re happy to share that Indonesia’s National Public Procurement Agency (NPPA = LKPP) has again opened its e-Catalogue to imported medical devices. This means that both imported and domestic Medical Devices and Health Service Support Equipment (Non-Medical Devices) can be submitted. The e-Catalogue was last opened to imported medical devices in
Catch up on the important regulatory changes that are coming your way in 2021 for medical devices in Southeast Asia in the recording of our live presentation at the Medical Fair Asia, in December 2020. Shouzheng Tan presented a quick fire 20-minute overview of the “Key regulatory changes for 2021
Updated guidelines on the evaluation of COVID-19 test kits have been released by the Research Institute for Tropical Medicine (RITM) in the Philippines, which cover the “…Evaluation of In Vitro Diagnostic Medical Devices and other related laboratory diagnostic supplies for COVID-19”. These guidelines cover the evaluation of PCR test kits,
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