30 March 2020
REQUIRED DOCUMENTS FOR MEDICAL DEVICE RELATED TO COVID-19 REGISTRATION
Due to the Coronavirus Outbreak (COVID-19), Thailand is currently in need of medical device related to battle the outbreak. Food and Drug Administration Committee Secretary announced as follows:
1. Medical device in Attachment shall be defined as "Medical Device".
2. Certificate of Free Sale (CFS) for medical device registration must include details as follows:
2.1 Manufacturer name and address
2.2 Product owner name and address
2.3 Message indicate that the medical device is being market in country of origin.
2.4 Product name. Product Specification: model; size; code.
2.5 Certificate of Free Sale (CFS) issued date.
3. Sterile product must attach ISO 13485 or Good Manufacturing Practice (GMP)
4. Legalization of document in (2) and (3) is not required.
5. Certificate of Free Sale (CFS) has 2 years validity accordingly to 2.5.
Translated from official ThaiFDA announcement, by:
Attachment of Food and Drug Administration Announcement regarding Required Documents for Medical Device related to COVID-19 Registration for medical device as follow:
1. Surgical Mask
2. N95 Mask or higher
3. Personal Protective Equipment: PPE
4. Surgical Gown
5. Isolation Gown
6. Medical Hair Cover
7. Medical gloves
9. Medical Goggles
10. Face Shield
11. Hood covering
12. Leg covering
- Food and Drug Administration Announcement regarding Required Documents for Medical Device related to COVID-19 Registration
- Turnaround Flow-chart for Medical Device related to COVID-19 Registration