Home About Qualtech NEWS THAILAND: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance – May, 2019
THAILAND: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance – May, 2019

May 10, 2019

With the current air quality situation of exceess severity level of PM 2.5, which is adversely affecting both acute and long-term health, Thailand government has issued a policy to reduce the PM 2.5 impact on people’s health. PM 2.5 refers to tiny atmospheric particulate matter (PM) that have a diameter of less than 2.5 micrometers. In concern of their minute size, PM 2.5 are able to bypass the nose and throat and penetrate deep into the lungs as well as enter the circulatory system.

Anyone who wishes to import medical masks must ensure they come 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 procedures 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.                                                                                


Reference:
Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance

 

Tags:

Thailand Registration

 

Follow us here and stay updated on all latest happenings in Asia medical device market and more:

 Facebook iconLinkedin iconTwitter icon

 

 
Home About Qualtech NEWS THAILAND: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance – May, 2019