Thailand’s Ministry of Public Health has announced the medical devices that exempted from compliance with certain control measures by virtue of the Section 5 paragraph 1 and Section 6 (18) of the Medical Device Act B.E. 2551. Minister of Public Health with recommendations of the Committee Medical devices therefore announced as follows:
Surgical Gown or Isolation Gown, Coverall, Disposable Surgical Mask and Disposable Surgical Mask N95 or higher are classified as medical devices as Section 6 (18) of the Medical device Act, B.E. 2008. The listed medical device are exempted from compliance with certain control measures under Medical device Act, B.E. 2008.
The decree has been implemented starting from August 13, 2020 onwards.
References:
THAILAND: ThaiFDA announces a series of regulations for COVID-19 kit and solution – June 2020