THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES

The Thai FDA has amended the Medical Device Act, 2009, and Medical Device Ordinance, 2018 (as amended) to add a Concise Evaluation option for qualifying Notified and Licensed medical and IVD devices. The new evaluation process eliminates the requirement for a Fee Sales Certificate / Certificate to Foreign Government issued from the country of origin. Guidance was published on September 30, 2019 with immediate effect. 

QUALIFICATION

To qualify for Concise Evaluation, a medical device must be registered (through full evaluation) and marketed for more than one year without any serious adverse events in 2 of 5 reference markets listed below; or in 1 of the markets for at least three years.

  1. Australia: Therapeutic Good Administration (TGA)
  2. Canada: Health Canada (HC)
  3. European Union:  Notified Body (EU NB)
  4. Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
  5. USA: Food and Drug Administration (FDA)
NEW DOCUMENT LIST

In addition to the same documents required for a Full Evaluation, the following additional documents are required for the Concise Evaluation:

  1. Market Approval from regulatory authority in reference countries
  2. Marketing History Declaration
  3. Manufacturer Safety Declaration to confirm no reported deaths, serious deterioration in the state of health, open field safety corrective actions (recalls) at the point of submission of the application
  4. Declaration Letter that Device Quality; intended use, indication packaging, labeling, instructions for use for supply in Thailand are identical as that approved by the reference agency.
  5. Letter of Certification conformity to Concise Evaluation

For IVD devices, the products must also be included on the World Health Organization’s (WHO) list of pre-qualified IVD products (list available here).

Asia Actual has a strong regulatory team in Bangkok to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.