In an effort to enhance the efficiency of the medical device approval process, the Thai FDA has revised the required documentation. The new regulations, effective June 6, 2024, aim to streamline the evaluation process without compromising safety or effectiveness by reducing the amount of necessary documentation. This particular move is part of a broader strategy to bolster Thailand's medical device industry and stimulate economic growth.

 

Key Changes to the Approval Process
Currently, applicants seeking registration for Class 2, 3, 4 medical devices in Thailand have two primary pathways: the Full Pathway and the Abridged Pathway (formerly known as Concise Evaluation).

List of Documents	Full Pathway	Abridged Pathway
Device Labeling	ü	ü
Device documents (Packing Insert / IFU)	ü	ü
Executive Summary	ü	ü
Device Description	ü	ü
Essential Principal Checklist	ü	ü
Summary of design verification and validation, including pre-clinical test reports and Clinical Evaluation Reports (CERs)	ü	EXEMPTED
Risk Analysis	ü	EXEMPTED
Manufacturer information	ü	ü
Ways of deterioration after use	ü	EXEMPTED
QMS certificate	ü	ü
Declaration letter on quality/ packaging/ labeling/ instruction for use	EXEMPTED	ü
Marketing history declaration	EXEMPTED	ü
Safety declaration	EXEMPTED	ü
Approval evidence from reference agencies	EXEMPTED	ü
Declaration of Conformity	ü	ü
Letter of Authorization (for importation)	ü	ü

Eligibility Criteria for the Abridged Pathway

To qualify for the Abridged Pathway, devices must meet the following criteria:

1. Devices must have obtained prior approval from recognized reference agencies such as the Australia TGA, Canada HC, European EU NB, Japan MHLW, US FDA, WHO PQ IVD, for a minimum duration of one year.
2. The trade name, intended use, indications, labeling, instructions for use, and packaging must be identical to the approved information from the reference agency.
3. The medical device must not be subject to specific controls outlined by the Ministry of Public Health.

 

Additional Notes

• Medical devices exempt from the evaluation of quality, efficiency, and safety by the referring agency, such as those with Listing or Exempted product approvals, are not eligible for the Abridged Pathway.
• Even under the Abridged Pathway, the Thai FDA reserve the right to request additional information or reports if there is a doubt regarding the standard quality, efficiency, and safety of medical devices.

 

Impact on the Medical Device Industry

These regulatory enhancements are expected to:

• Reduce time-to-market: Faster approval times allow companies to introduce innovative products sooner.
• Lower costs: Reduce costs through streamlined processes
• Attract foreign investment: A more efficient regulatory environment can make Thailand a more attractive destination for medical device companies.
• Enhance patient access: Accelerated approval times can lead to quicker availability of life-saving and life-improving medical devices.

 

Conclusion:
By eliminating redundant documentation requirements, the Thai FDA seeks to expedite the evaluation process and create a more favorable environment for medical device companies. This strategic move is anticipated to stimulate growth within the domestic medical device industry while also attracting international players to the Thai market.

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References:

1. Thai FDA Announcement: Prescribed Information, Documents, and Evidence That Are Not Required for Licensing and Issuance of Licenses to Manufacture or Import Medical Devices, and Notification and Issuance of Receipts for Notifying Manufacturing or Importing Medical Devices, 2024
2. The Thai FDA Reduces Redundancy Documents for Medical Device Importation to Facilitate Entrepreneurs
3. Thai FDA Medical Device Product Registration Pathway