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.
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.
- Australia: Therapeutic Good Administration (TGA)
- Canada: Health Canada (HC)
- European Union: Notified Body (EU NB)
- Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
- 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:
- Market Approval from regulatory authority in reference countries
- Marketing History Declaration
- 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
- 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.
- Letter of Certification conformity to Concise Evaluation