Medical Device Registration Thailand
Medical Device Registration Thailand in Thai FDA follows the guidelines given by the latest Medical Device Act 2019, enforced in november 2019.
The new law harmonized the Medical Device classification and registration process with international community and ASEAN CSDT.
Medical Device Registration Thailand Classification drasticall changed, and now every Medical Device is considered according to risk factor and not by a mere division in classes. The new division in Active Medical Device, non Active Medical Devices, Invasive and non-invasive, etc makes the classification completely different than before.
Generally speaking a class I in Europe/USA shall be considered class III in Thailand, and vice-versa a class III shall be class I in Thailand. We suggest a regulatory pre-check before any decision in pre-market assessment.
Consequently, the required documentation changes according to classification. Class III is generally easier and more a matter of communication and explaination of the device, while a class II (generally active and invasive devices) require a strong and complete documentation, including clinical reports.
Time frame also vary from 3 weeks for Generic Medical Devices to 4/6 months for a class II
Medical Device registration procedure
In thai FDA you have two options for the registration of class I and II Medical Devices: submission or consignment. This means that the registrant has to decide if using Thai FDA commission for evaluating the Medical Device or if he prefers the self-assessment by using his own specialist (must be a Thai Doctor Specialist in the sector of the Device under registration.
Following the obtained certification for the device, an advertisement license shall be required in order to promote the device on the market (media, Internet, and also brochures).
A Medical Device license shall be valid until Free Sales Certificate expiration in Class III and for three years for Class I and II.
If you want to register a Medical Device in Thai FDA you can contact us for a quotation. Siam Trade Development works in Joint-venture with Kha Group and can cover all the necessary step for market entry: pre-market, license holding, import, warehouse, delivery (3PL), and compliance.
Contact us now to ask a quotation for your medical device registration.