info@wiselink.com.au
1300 76 80 90
Medical Device Registration Services - Thailand
Regulatory Department
Medical Device Control Division (MDCD), under Thailand Food and Drug Administration (TFDA)
Regulation
Medical Device Act, B.E. 2531 (1988)
Recognised Quality Management System
Regulatory Classification & Registration Process
Class I – Lowest Risk
-
Compliant with ISO 13485 requirements
-
Product certification from the manufacturing country required
-
Certificate of Free Sales (CFS) from the manufacturing country required
-
Medical supply must be imported by a recognised Thai importer
-
Registered and listed on Thailand Food and Drug Administration
-
Timeframe: 200 days
Class II
-
ISO 13485 Certification
-
Product certification from the manufacturing country required
-
Certificate of Free Sales (CFS) from the manufacturing country required
-
Medical supply must be imported by a recognised Thai importer
-
Registered and listed on Thailand Food and Drug Administration
-
Timeframe: 250 days
Class III
-
ISO 13485 Certification
-
Product certification from the manufacturing country required
-
Certificate of Free Sales (CFS) from the manufacturing country required
-
Medical supply must be imported by a recognised Thai importer
-
Registered and listed on Thailand Food and Drug Administration
-
Timeframe: 250 days
Class IV – Highest Risk
-
ISO 13485 Certification
-
Product certification from the manufacturing country required
-
Certificate of Free Sales (CFS) from the manufacturing country required
-
Medical supply must be imported by a recognised Thai importer
-
Registered and listed on Thailand Food and Drug Administration
-
Timeframe: 300 days
* A Thai medical supply importer is required to represent overseas medical device manufacturers. We will be able to manage this for you..
​
​
Looking to register your medical device in Thailand? Contact us today!
​
​