A new Procedure for Registration of Medical Device in Thai FDA will be enforced soon, probably from early December.
This is what came out from our latest visit to Medical Device Division in Thai FDA of Nonthaburi, the main office controlling all the Kingdom of Thailand.
The new procedure is not effective yet: it is still under discussion of the FDA Committe. But it is more than a rumor, it’s a real new that only who lives daily the reality in this sector can disclose.
The New Procedure for Registration of Medical Device in Thai FDA will drastically change documentation, timeline, method and costs. Documentation volume will be increased, control will be more strict to give a better protection to Consumer. This will turn out in additional costs, and more time will be needed to complete a Medical Device Registration.
We can’t actually disclose what will be the new requirements, but we can say that until the day the New Procedure for Registration of Medical Device in Thai FDA will be enforced, things shall remain unchenged. With a plus: whoever wants to start a registration process before the new rules are enforces, will be authorized to proceed even in lack of the notarization of free sales certificate and ISO certificates, that can be provided to Thai FDA after the registration has been finished.
This very important detail will help the “last minute” registrants to finish their Registration process in Thai FDA following the old, actual rules, saving time and money.
As for every drastic change in Governmental procedure, we expect a period of adjustment which will inevitably lead to confusion, delays, and numerous rejected applications.
This happened already in 2018 with the informatization of applications and in 2019, when THAI FDA switched to the new Asean system (with the CSDT). This new procedure will be yet another improvement in the Thai certification system that will further reduce the number of “freelancers” with dubious skills and foreign companies operating in the online sector without real knowledge of the regulatory environment.
In Siam Trade Development we are very attentive to the training of our staff and to updating procedures. For any information contact today [email protected]
UPDATE MARCH 2021
The new procedure has been finally implemented on Febraury 15th 2021 and is widely explained in this article: Thai Medical Device Regulation 2021