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THAILAND: Thai FDA Withdraws Exemption Announcement on Surgical Gown, Isolation Gown and Coverall Under Special Registration Route – May, 2021

THAILAND: Thai FDA Withdraws Exemption Announcement on Surgical Gown, Isolation Gown and Coverall Under Special Registration Route – May, 2021

  • 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

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 PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

  • 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

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