Minister of Public Health with the recommendation of the Medical Device Committee, has made the following announcement:
1. Withdrawal of Medical device Exemption under Section 6 (18) of Medical Device Act B.E. 2551 (No. 2) announced on July 16, 2020, abolishing the special route registration of surgical gown or isolation gown and coverall.
2. Withdrawal of Medical device Exemption under Section 6 (18) of Medical Device Act B.E. 2551 (No. 3) announced on July 20, 2020, also abolishes the special route registration of the disposable surgical mask and disposable surgical mask N95 or higher.
3. This decree is in force since March 17, 2021.
Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.