Thailand: TFDA Update CONCISE Method requirement for Medical Device Registration

Thailand FDA prepared a systematic CONCISE method to assist with medical device registration submission. The CONCISE method is expected to shorten the approval period by 2 to 3 months and waives the expert review fee for dossier review by the internal regulators.

A new requirement update for medical device registration through the CONCISE method is TFDA now only accepts 1 reference country for 1 year approval period. Previously, TFDA may accept minimum 3 years approval period for 1 reference country and 1 year minimum approval period for 2 or more reference countries. The reference countries are:

• European Union Notified Bodies (EU NB)

• Health Canada (HC)

• Japan Ministry of Health Labour and Welfare (MHLW)

• Therapeutic Goods Administration (TGA)

• US Food and Drug Administration (US FDA)

• WHO Prequalification of In Vitro Diagnostic (IVD)

On the other note as a reminder, there are also other requirements required to abide which are: only medical devices categorized under Class 2, Class 3, and Class 4 are applicable through the CONCISE method and all the medical device information must be identical to the information approved by the reference countries (Trade name, model, labeling, intended use and indication, IFU, product code, packaging and the name and address of the physical manufacturer).

Concise method requirements include the same documents as Full evaluation and also the following:

• Regulatory authority approval from reference countries

• Manufacturer safety declaration

• Marketing history

• Certification Conformity Letter for concise evaluation

The registration reduction period is aiming to shorten the processing period. Meanwhile, the expedited processing fee would be reduced by 38, 000 Baht for Class 2 and Class 3 medical devices and 53, 000 Baht for Class 4 medical devices.

Source: Medical Device Control Division Thailand