The Thai Food and Drug Administration (TFDA) implemented a new notification aimed to simplify the registration process of medical devices under the “Specification of Data, Documents, or Evidence Not Required for Submission under the Ministerial Regulations on the Permission and Issuance of Licenses for the Manufacturing or Importation of Medical Devices and the Notification License and Issuance of Listing Certificates for the Manufacturing or Importation of Medical Devices, B.E. 2567 (2024)”.
This initiative seeks to expedite business operations, reduce unnecessary paperwork, and ultimately stimulate economic growth within the medical device industry. There are 2 (two) registration pathways mentioned in this announcement:
- Full pathway. There are 3 options to proceed evaluation of quality, performance, and safety:
- Evaluation by external experts
- Evaluation by TFDA staff
- Reliance Program
- Abridged pathway. This streamlined option is available for medical devices with a proven track record of foreign agencies’ approval. Recognized agencies include:
- Therapeutic Goods Administration (TGA)
- Health Canada
- European Union Notified Bodies (EU NB)
- Japan Ministry of Health Labor and Welfare (MHLW)
- US Food and Drug Administration (US FDA)
- World Health Organization (WHO)
To qualify for the Abridged Pathway, medical devices must meet these criteria:
- At least 1 (one) year of authorization from a recognized agency
- Identical intended use, indication, labeling, instructions for use, and packaging compared to the previously approved version.
The Abridged Pathway does not apply to medical devices under specific announcements or those exempted from quality, efficiency, and safety evaluations by foreign agencies (e.g., Listing or Exempted Product Approval).
Documents that are exempted from the Full pathway and Abridged pathway are as follows:
| Required Documents | Full Pathway | Abridged Pathway |
|---|---|---|
| Labelling | ✓ | |
| Instruction for use | ✓ | ✓ |
| Executive Summary | ✓ | ✓ |
| Device Description | ✓ | ✓ |
| Essential Principles | ✓ | ✓ |
| Summary of Design Verification and Validation | ✓ | Exempt |
| Risk Analysis document | ✓ | Exempt |
| Manufacturer information | ✓ | Exempt |
| Waste disposal document | ✓ | Exempt |
| Quality system certificate | ✓ | ✓ |
| Declaration Letter of intended use, indication, packaging, labelling, and instructions for use | Exempt | ✓ |
| Marketing History Declaration | Exempt | ✓ |
| Safety Declaration | Exempt | ✓ |
| Evidence of regulatory approval | Exempt | ✓ |
| Letter of Authorization for Authorized Representatives | Import only | Import only |
| Grouping declaration letter | If any | If any |
This Announcement shall come into force starting from the day of its publication in the Government Gazette on June 6, 2024. Further information can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) and the infographic (in Thai).
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.