With the current situation of the exceed severity level of PM 2.5, which adversely affecting both acute and long-term health, the government had issued a policy to reduce the PM 2.5 impact on people’s health.
Anyone who wishes to import medical masks with indications from the manufacturer/product owner that the medical mask is capable of dust and germs prevention and it is for medical use, which is considered to be classified as a general medical device. Importers must proceed registration of Importer Establishment License as well as registration of Medical Device Import License. ThaiFDA with the collaboration of the Customs Department has reduced the procedure duration. The total duration is approximately 20 working days.
Importation procedure are as follows:
1. The importer must prepare the registration of the Importer Establishment License following the format of Fast track via One stop service (Specify for importation of medical masks) at ThaiFDA.
2. Authorized for the accessing the registration via E-submission at ThaiFDA.
3. Requirement of Certificate of Free Sale for importer to proceed importation registration via E-submission are as follows:
3.1 Certificate of Free Sale;
3.2 Catalog or product labelling;
3.3 Affirmative of presenting the correct Certificate of Free Sale in accordance to the Food and Drug Administration regulations and exempted medical device which is not required to present Certificate of Free Sale at the Food and Drug Administration, 2007. Submission of Certificate of Free Sale must be made within 180 after receiving Certificate of Free Sale.
4. Call 02-590-7248 to notify the Medical Device Control Division officer reference no. by specifying that it is an importation of a medical mask.
Translated from official ThaiFDA announcement, by: