ThaiFDA is highly concerned with the efficiency and safety of the product. They are keen on raising awareness for establishments to be prepared in providing “Technical Documents” once they requested by the ThaiFDA authority.
Technical documents can be stored in both print documents/electronic document versions. Technical document can be prepared in either Thai/English and stored at manufacturing site/ place of importation. The preparation of Technical document must comply with the Attachment of the announcement, as following:
1. Registration No.
2. Product; common name and trade name
3. UMDNS Code
4. Name and address of manufacturing site
5. Name and address of product owner/distributor
6. Executive summary
7. Essential Principles of Safety and Performance of Medical Device and method used to demonstrate conformity
8. Device description
9. Summary of design verification and validation documents
10. Device labelling
11. Medical Device Document (if any)
12. Risk Analysis
13. Manufacturer Information
14. GMP or quality system certificate (if any)
15. Letter of authorization for authorized representatives (Importation)
16. Waste disposal
17. Adverse Effects & FSCA
18. Test report, Batch record / Lot release
It is hoped that manufacturers will benefit from this announcement in preparing these Technical Documents way ahead and cut short the evaluation time for their devices’ registrations with ThaiFDA.
- Ministry of Public Health Announces the Draft regarding Rules, Procedures and Conditions in Preparing Academic Documents and Information Ensuring that the Medical Device is Qualified, Standardized, Efficiency and Safety for Inspection Purpose or sent to Authority Upon Request