Thailand FDA shares 2019 Medical Device Regulation Plan

December 17, 2018

During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical devices.

 

Pre-Market Control

 

An overview of the pre-market control of medical devices in Thailand is as seen in the diagram below:

 

 1. Risk classification

 Licensed medical devices are considered the highest risk while general medical devices are considered the lowest risk. 

 

For more information on medical device classification rules for Non-IVD in Thailand,

click here.

 

2. General Medical Device Submission

 

Licensed and Notified medical device: One Stop Service Center (OSSC); Hard copy submission

General medical device: SKYNET; Soft copy submission

 

3. Grouping

 

The medical device can be grouped together and submitted in one product registration application, i.e. Single > System > Family > Set. This regulation is currently in process and is expected to come into effect in 2019.

 

4. Voluntary CSDT submission

 

Only manufacturers or importers of specified medical devices can voluntarily submit CSDT document. Such devices include:

  • Contact Lens care product

  • Injectable hyaluronic acid

  • Class 3 laser

This regulation is currently in process and is expected to come into effect in 2019.

 

5. Concise Evaluation

 

The concise evaluation route applies to medical devices that havae been approved in at least two of the GHTF countries: Australia, Canada, European Union, Japan and United States and possesses a marketing history of at least one year. Otherwise, a full evaluation route is required. This regulation is currently in process and is expected to come into effect in 2019.

 

Post-Market Control

 

Only manufacturers or importers of specified medical device listed shall be certified to Thai GMP or GDP, respectively. Such devices include:

  • Class 4 Medical Devices

  • Medical device Listed e.g. Condom, Surgical glove etc.

The Thai GMP is expected to comply with ISO 13485:2016. This regulation is currently in process and is expected to come into effect in 2019.

 

 

Lastly, the Thai FDA has released a medical device regulation handout (available in English):

 

For more information on the handout,

click here

 

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