Thai FDA publishes New MD Act

June 18, 2019

New Medical Device Act

 

Recently, Thailand FDA has just announced new Medical Device Act (more information will be given in an update meeting on 19 June).

 

Medical Device Act (rev. 2) – main changes are:

  • new definition of “Medical Device” to exclude “spare part” not to be under Medical Device and no registration is needed. But “Accessory” of Medical Device is still under Medical Device regulation.

  • Advertisement approval that exempt for healthcare professionals that no need to get pre-approval from Thai FDA. However, for advertisement for consumers still need FDA pre-approval.

  • External expert or organization can be assigned by the Authority to review the dossier, to speed up registration process

  • More details of FDA fee

 

New Contact Lenses Care Solutions Regulation

 

Contact lenses Care Solution Notification – Contact Lenses Care Solutions has now changed from “Drug” category to be “Medical device”. So, new submission of Contact Lenses Care Solutions will be in CSDT format, similar to Contact Lenses.

 

General Medical Device (low risk Class III) CSDT Submission

 

As it is still the transition period now, there is no clear timeline on the effective date for submission of CSDT and with the correct Class A to D for general medical device (low risk Class III).

 

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