Respectively Thai Ministry of Public Health has announced that all listed medical devices must comply with a set of standards, which have been stated in the Announcement.
The listed medical devices are as follow:
|
No. |
Medical Device |
Standard |
|
1 |
Surgical Gown or Isolation Gown |
Effectiveness in protective permeable e.g. body liquid, virus or others that meet appropriate performance standards in way for healthcare users. |
|
2 |
Coverall |
Effectiveness in protective permeable e.g. body liquid, virus or others that meet appropriate performance standards in way for healthcare users. |
|
3 |
Disposable Surgical Mask |
Effectiveness in others e.g. bacterial filtration, particulate filtration, fluid resistance, and biocompatibility. |
|
4 |
Disposable Surgical Mask N95 or higher |
Effectiveness in others e.g. particulate filtration, fluid resistance, loose-fitting, and biocompatibility. |
The decree has been implemented starting from August 13, 2020 onwards.
References:
THAILAND: Ministry of public health announces the standard of medical device that manufacturer or importer must comply 2020 – June, 2020
Ministry of Public Health Announce Additional Standards of Medical Device to Comply in 2020 (No.2)
Ministry of Public Health Announce Additional Standards of Medical Device to Comply in 2020 (No.3)