On November 2018 the system of medical device registration in Thailand changed drastically according to ASEAN rules.
Generally speaking, the division in 3 classes is still in use:
- Class 1 – General Medical Devices, that must be now submitted electronically (e-submission)
- Category 2 – Notified Medical Devices, that must be now submitted according the CDTS (Common Submission Dossier Template)
- Class 3 – Licensed Medical Devices, as well subordinated to CSDT procedure but with a more detailed documetation.
A special procedure is dedicated to the so-called “innovative medical devices”, products never registered before in ASEAN Countries. If not widely used in at least 3 major areas of the world (Japan, Australia, USA, Europe, Canada) must be submitted to a commission which will consider its effectiveness and safety.
What changed in ASEAN Medical Device Registration?
Main difference is that the Risk class can define the sub-classification
of the Medical Device and affect the proedure or the request of documentation in Thai FDA.
Summarizing, the system is now more similar to European or American, that means more safety and more accuracy. But, on the other side, more cost and more professionalism required in the Agency managing the registration.
Another side effect of new regulation is that Distributors, specially in case of “invasive devices” (with higher risk class) or class 2 (most of device for physiotherapy) will refuse to follow the Medical Device registration in Thailand at their own expenses; they will request as general assumption a product “ready to sell”.
Why should I consider to proceed with my medical device registration in Thailand before selling?
Law is clear: you can’t import, promote, test any nedical device if not previously registered in Thai FDA. The common practice of Clinical Tests in hospitals is not doable, since every (serious) hospital will ask you before even opening the discussion the registration number, a copy of free sales certificate and of ISO 13485 (if sterile). The old practice followed by hospitals to register devices of their interest is not enforce anymore. Thus, if you choose to sell directly to hospitals, you will need a Licence Holder (or Marketing Authorized holder, or Master Distributor).
With new ASEAN regulation enforced in Thailand, a License Holder is now a must. The Do-it-by-yourself is not possible anymore, and small players (some of them with good products but bad attitude toward the market) are really experiencing hard times.