Manufacturer / Importer of Medical Devices
“manufacture” means an act of making, assembling, inventing, divisional repackaging, combinational re-packaging, improving, transforming, modifying or sterilizing
“import” means an act of bringing or ordering into the Kingdom
Manufacturer / Importer of Medical Devices for Commercial Purpose
Step 1 : Establishment Licensing
Any person who wishes to manufacture or import medical devices shall carry out registration of an establishment with the Thai FDA.
Step 2 : Product Registration
In order to regulate medical devices effectively, risk-based classification is additionally used to classify medical devices into 4 classes as shown in diagram below. The risk-based classification is harmonized with the regional and international regulations to assure safety and performance of the devices as well as to protect consumers and patients appropriately.
An establishment registrant who would like to register a medical device in Thailand must first classify the risk of the medical device. Registration requirements will differ depending on the devices’ risk classification as the table below.
Medical Device Risk Classification | Risk level | Submission Dossier | Certificate |
Class 1 and Animal Medical Devices | Low risk | Click here | Certificate of Listed medical Devices |
Class 2 | Low-moderate risk | Click here | Certificate of Notified Medical Devices
|
Class 3 | Moderate-high risk | Click here |
Class 4 | High risk | Click here | Certificate of Licensed Medical Devices |
You can check your devices' risk classification here by answering a few questions
There are 3 pathways for medical device registration in Thailand:
- Full evaluation
- Concise pathway
- Reliance program
More information regarding CONCISE PATHWAY and RELIANCE PROGRAM are shown below.
The registrant shall carry out the manufacture or import when the licensor has issued the certificate of licensed or notified or listed medical device.
Manufacturer / Importer of Medical Devices for Other Purposes
Establishment licensing and product registration aforementioned shall not apply to:
(1) the manufacture, import or sale of medical devices by State agencies in the discharge of duties in connection with the prevention, diagnosis or treatment of diseases or the rehabilitation and the Thai Red Cross Society
(2) the manufacture of medical devices specifically for the purpose of sterilisation in medical establishments under the law on medical establishments
(3) the manufacture or sale of medical devices manufactured by medical and public health practitioners for their particularly individual patients or animals
(4) the sale of medical devices, in respect of which a licence, a specification declaration certificate or a notification certificate has been granted, by medical establishments or medical and public health practitioners for their particularly individual patients or animals;
(5) the manufacture or import of medical devices in the quantity meeting the necessity for personal use, for use as samples, for an exhibition or for use in studies, research, analysis or tests of the quality and standards
(6) the import of medical devices for particularly individual patients or animals
(7) the manufacture of medical devices as samples for export
(8) the manufacture or import of medical devices in accordance with the rules, procedures and conditions prescribed in the Notification of the Minister with the recommendation of the Commission
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