Thai FDA ‘Concise Evaluation’ alternative replacing Free Sale Certificate or Country of Origin Cert

Thai FDA issued an announcement for alternative Concise Evaluation route for registering Notified and Licensed medical device, including IVD devices. This alternative route allows Manufacturer to use the reference agency approval document instead of the Country of Origin certificate or the Free Sales Certificate. It is immediately effective from 30 September 2019.

Concise Evaluation is applicable in the following options:

Option 1

• Marketing approval in 2 or more reference countries, and

• Marketed for at least 1 year

Option 2

• Marketing approval in 1 reference country, and

• Marketed for at least 3 years

Option 3

• Marketing approval in 1 reference country, and

• Marketed for at least 1 years

• Product in World Health Organization’s (WHO) list of pre-qualified IVD products.

Reference countries approval

1. Australia Therapeutic Good Administration (TGA)

2. Canada Health Canada (HC)

3. European Union Notified Body (EU NB)

4. Japan Ministry of Health, Labour and Welfare (MHLW)

5. United States Food and Drug Administration (US FDA)

Documents required including:

1. Approval documents from Regulatory agencies reference countries. If the medical device registration based on Mutual cooperation between the two reference agencies, it is considered as 1 country reference agency approval.

2. Declaration on Marketing History

3. Declaration on Safety with no reportable death, serious deterioration, open Field Safety Corrective Action/Recall

4. Declaration on Device information with intended use, indication labeling, instructions for use and packaging, for supply in Thailand is identical to the product approved in the country reference agency.

5. Declaration of Conformity to Concise Evaluation

Reference: Thai FDA

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