Medical device registration in Thailand
All medical devices, whether manufactured domestically in Thailand or imported, must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Registrations of Licensed Medical Devices, Notified Medical Devices and Listing Medical Devices are submitted via the online medical device registration system called the “Pre-submission & E-submission system”.
Who can register a medical device in Thailand?
In order to register a medical device in Thailand, a company must first obtain an Establishment License for manufacture or import of the medical device.
The Establishment License can be applied for via manual submission and once approved it will be issued by the Thai FDA.
Currently, only people of Thai nationality or local (Thai) established companies can apply for an Establishment License. Foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Thailand:
Set up a legal subsidiary entity
to register the medical devices. There may be restrictions on ownership so please seek legal guidance.
Appoint a local distributor
distributor who holds an Establishment License (Importer’s License) in Thailand to register the medical devices.
Appoint an independent third party
1a) such as Andaman Medical to register the medical device. Andaman Medical has a fully certified Establishment License (Importer’s License) and acts directly on behalf of foreign manufacturers.
1b) such as Andaman Medical to register the medical devices on behalf of a local distributor who has an Establishment License (Importer’s License). This option is useful in case your preferred local distributor does not have an internal regulatory affairs service. See below for more on how we can help.
Once you have chosen your route-to-market and have ensured that the local company has the required and valid Establishment License, the holder of this Importer’s License may then proceed to register the medical device with the Thai FDA. See below for information on the new registration processes.
Once the medical device has been registered and approved, the Thai FDA will issue a Listing Certificate, Notification Certificate and License whichever is applicable.
The company which receives the Product Certificate or License is also known as the Product License Holder. Multiple registrations of medical devices with different Importer License Holders are allowed in Thailand. However, change of ownership or transfer of the Product License from one Importer’s License Holder to another is not allowed.
Definition and classification of medical devices in Thailand
As of February 2021, there are 4 (four) risk classification categories as opposed to 3 (three) previously and they apply to both IVD and non-IVD products as follows:
|Previous classification||New classification||Date comes into force|
|General||Class 1 - Listing||Class 1- March 17, 2021|
Class 2 - Notified
Class 3 - Notified
|Class 2 to 4 – Feb 15, 2021|
|Licensed||Class 4 – Licensed|
(1) a device, an appliance, a mechanical tool, an object inserted into the body, a solution used for performing a test inside or outside a laboratory, a product, software or any other object specifically intended by the manufacturer or owner to be used, for any one or more of the following purposes, on human-beings or animals, whether independently from, in conjunction with or as an accessory of any other article;
provided that the achievement of the purposes of the articles mentioned under (1) occurring in the human or animal body must not principally result from a pharmacological or immunological process or a metabolic reaction.
(2) supplementary equipment for use in conjunction with a medical device under (1);
(3) a device, appliance, mechanical tool, product or any other object prescribed in the Notification of the Minister as a medical device;
“supplementary equipment” means an article, appliance or product specifically intended by the manufacturer or owner to be used in conjunction with a medical device for facilitating or causing such medical device to be usable for the intended purpose thereof.
Medical device grouping in Thailand
IVD Test Kit
What documents are required to register medical devices in Thailand?
Various documentation is required to register a medical device in Thailand. The language accepted for submission is English. In general, you will be required to submit a device description, any pre-clinical studies, device labelling, instructions for use, a risk analysis and of course any existing regulatory approvals or market authorisations already obtained and manufacturer’s compliance for ISO 13485.
Certain medical devices require separate Thai FDA permits or registrations from other government agencies such as those which contain or transmit radiation and those with wireless connectivity. And some specific products must undergo local testing in an accredited laboratory in Thailand.
There have been recent changes to the registration process in Thailand which come into effect during February and March 2021. Different processes are to be followed according to the product’s classification and whether it is a new registration or an already registered medical device in Thailand. The current length of validity of the product license will also determine the process to be followed:
For Class 1 Listing Medical Devices:
For Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices:
All medical device product registrations must be submitted online via the Pre-submission and E-submission system. The filing of applications for medical device product registrations are subject to the Medical Device Act, B.E. 2551 (2008) and Medical Device Act (Version 2), B.E. 2562 (2019).
Once the necessary documentation has been uploaded in the E-submission system according to the product’s class, an order of payment will be generated. The registrant has to process payment for the application.
Once payment is received, the Thai FDA will start to evaluate the submission. Should all documentation meet the requirements, then the Thai FDA will issue the Listing Certificate, Notification Certificate or License. However, the Thai FDA may consider that the documentation submitted does not meet the requirements and thereby request additional documentation. At this stage, the Thai FDA will evaluate the submission again, and if successful an authorization will be provided or if not, then the submission will be rejected.
Currently, regulations allow for the renewal of medical devices, with fewer documentation being required than for new registrations.
Typical fees and timelines
A fee is payable for each medical device registration. This is a non-tax fee. Below are the new fees as of March 2021 and the respective turnaround times for e-submissions.
|Item||Class 1 Listing||Class 2 Notification||Class 3 Notification||Class 4 License|
THB 500 (~US$17)
Effective on: 17th March 2021
THB 1,000 (~US$35)
Effective on: 17th March 2021
|THB 1,000 (~US$35)|
THB 2,000 (~US$70)
Effective on: 17th March 2021
|THB 10,000 (~US$335)||THB 20,000 (~US$670)|
|Turnaround time||200 working days||250 working days||300 working days|
How Andaman Medical can help:
Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.