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THAILAND:  Medical Device Registration Exemption Criteria, Methods and Conditions  prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

THAILAND: Medical Device Registration Exemption Criteria, Methods and Conditions prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

  • 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

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USA: FDA Modifies List of Recognized Standards – June, 2021

USA: FDA Modifies List of Recognized Standards – June, 2021

  • 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

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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In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95,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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