Regulatory Affairs Update: Thailand

Thailand: FDA Announced a Comprehensive Guide to Evaluating Academic Documents and Medical Device Licensing Inspections

Thai Food and Drug Administration (FDA) announced the Criteria, Methods, and Conditions for Evaluating Academic Documents, Analysis, Establishments Inspection or Inspections for Consideration and Permission of Medical Device Licensing, B.E. 2567 (2024). The goal is to streamline the licensing process for medical devices while maintaining high quality, efficiency, and safety standards.

Highlights of the announcement are as follows:

  • Clause 1: This announcement shall come into force thirty days after its publication in the Government Gazette.
  • Clause 2: The following medical device licensing processes do not require evaluation of scientific documents by individuals, agencies, or organizations registered with the FDA:
  1. Application for the license of a medical device for manufacturing or importation, and notification of medical device for manufacturing or importation.   

(a) Applications for medical devices that have been approved or authorized by foreign agencies recognized by the FDA.

(b) Applications for medical devices require preparing documents for a streamlined (short process) review process by referencing foreign regulatory approvals.

(c) Applications for medical devices that meet the criteria for referencing existing documentation or transferring documentation of previously approved medical devices.

Exceptions to the above:

  1. Medical devices with a history of serious adverse events or device deficiencies that bring about serious adverse device effects.
  2. Cases in which there is reasonable doubt about the medical device’s quality, efficiency, and safety.
  3. Submission of change notification in case of items or descriptions that do not affect the indications, intended use, manufacturing processes, quality, efficiency, or safety of the medical device unless in case of reasonable doubt about the quality, efficiency, and safety.

2. Submission of medical device advertisement applications:

(a) Showing the content of quality, quantity, or label out of the scope of registration, but the details can be supported by scientific evidence. However, that content shall not relate to the medical device’s indications or intended use.

(b) Advertisements must submit a document evaluation according to Thai FDA guidelines.

  • Clause 3: Remote audits for establishment license applications:

(1) Consideration of import or sales facilities.

(2) Consideration of change notification for manufacturing, import, or sales facilities:

(a) Adding or changing places for storage areas for medical devices.

(b) Reducing machinery or equipment in existing manufacturing facilities.

(c) Adding machinery or equipment to existing manufacturing facilities without affecting the main manufacturing process.

(d) Modify floor plans or diagrams in the existing place and scope that have been approved.

(e) Modifying the details of the establishment license for manufacturing, importation, and sales.

These are not enforced if necessary or if there is reasonable doubt about the on-site inspection at the facility.

The announcement can be accessed here (in Thai).

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