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

ISO 13485

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!