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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..

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Looking to register your medical device in Thailand? Contact us today!

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