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Thai FDA Ramps Up Documentation Requirements for General Medical Devices

Published October 9, 2020

With the announcement of The Regulations and Conditions Of Maintaining Technical Documents For Safety And Effectiveness Of The Medical Device, the Thai FDA has begun requiring the local medical device License Holder to provide upon request technical documents for any registered device. As the registration process for most General Medical Devices (all but 10 device types fit into this category) does not involve technical documents, this new requirement will impact most medical devices.

License Holders will be expected to produce the following documents upon request from the Thai FDA:

List of the DocumentsMedical Device Risk Classification
ABCD
Status of the registration ex. Imported license

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General name and trade name of the medical device

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Code of the medical device

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Name and address of the manufacturer

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Name and address of the company/person responsible for marketing the product

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Executive summary

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Essential Principles of Safety and Performance of Medical Device and method used to demonstrate conformity

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1.    Device Description

2.    Device description and features

3.    Purpose of use

4.    Indication

5.    Instruction of use

6.    Storage

7.    Shelf life

8.    Contraindication/Warning/Precautions

9.    Adverse events

10. Other Alternatives therapy

11. Components of the medical device

12. Product specification

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Summary of design verification and validation documents

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Test reports (Batch report/Lot release)

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Device Labeling

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User manual

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Risk analysis

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Manufacturer information

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ISO certificate

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Letter of authorization for authorized representatives (for the importer)

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Methods for disposal of waste and destruction after use

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Reports of adverse events

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Records must be kept for at least 1 year after the device expiry date. Records for devices with no expiry date must be kept for 5 years after being discontinued on the market.

This new requirement become effective for all Class A, B and C devices registered after June 13, 2020, and all Class D devices registered after September 11, 2020.

Asia Actual (Thailand) provides medical device registration and independent license holding services. Contact Asia Actual with any questions or requests for support services.

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