Newsletter

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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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In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95,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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THAILAND: Thai FDA announce that manufacturer and importer must proceed medical device to be licensed registration 2020 – June, 2020

THAILAND: Thai FDA announce that manufacturer and importer must proceed medical device to be licensed registration 2020 – June, 2020

  • 0000-00-00 00:00:00

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

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THAILAND: ThaiFDA announcement regarding required documents for medical device related to COVID-19 registration - May, 2020

THAILAND: ThaiFDA announcement regarding required documents for medical device related to COVID-19 registration - May, 2020

  • 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

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