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. Medical device registrations in Thailand must be submitted via the online medical device registration system called the “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 online 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
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.
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 |
| Notified | Class 2 - Notified Class 3 - Notified | Class 2 to 4 – Feb 15, 2021 |
| Licensed | Class 4 – Licensed |
Medical device grouping in Thailand
Single
Family
System
Set
IVD Test Kit
IVD Cluster
Thailand medical device registration requirements
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.
Medical Device Registration in Thailand
There have been recent changes to the medical device registration process in Thailand which came into effect in February and March 2021. Thailand’s medical device registration requirements follow different processes 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:
- Registered General Medical Device products with current approved certificates of less than 1 year of validity remaining as of the 15th February 2021 shall undertake Partial Submission of application for Medical Device Listing. Registered Products with Partial Submission can be imported to Thailand even while the process of approval from the Thai FDA is ongoing unless the application is rejected by Thai FDA. A Class 1 Listing Certificate is valid for 5 years. The full submission of documents is required during product renewal.
- New products and registered products with current approved certificates of more than 1 year of validity remaining as of the 15th February 2021 are required to undergo Full Submission and require approval from the Thai FDA prior to importation of the products into Thailand.
For Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices:
- A Classes 2 and 3 Notified Certificate as well as a Class 4 License is valid for 5 years. The full submission of documents is required, however, Partial 2 Submission is allowed for registrants who submitted their application during Feb 15, 2021 to Feb 14, 2024.
All medical device registrations in Thailand must be submitted online via the Pre-submission and E-submission system. The filing of applications for medical device 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 Thailand’s medical device registration 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 less documentation being required than for new registrations.
Typical fees and timelines
A fee is payable for each medical device registration in Thailand. 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 |
|---|---|---|---|---|
| Application fee | THB 500 (~US$17) Effective on: 17th March 2021 | THB 1,000 (~US$35) Effective on: 17th March 2021 | THB 1,000 (~US$35) | |
| Evaluation fee | THB 600 (~US$20) | THB 38,000 (~US$1,275) | THB 53,000 (~US$1,775) | |
| License fee | THB 2,000 (~US$67) | THB 10,000 (~US$335) | THB 20,000 (~US$670) | |
| Turnaround time | 1 - 80 days | 250 days | 300 days | |
Andaman Medical provides medical device registration services in Thailand:
Andaman Medical Thailand is a medical device consultancy that specializes in the registration, authorized representation, and importation of medical devices and in-vitro diagnostics into Thailand.
Our in-house team of local, experienced regulatory affairs specialists in Bangkok will provide you with unrivalled assistance on-the-ground expertise.
Our registration services include:
- Standard product registration
- Renewal of product registration
- Special access product registration
- Liaison with the local authorised government agency on all regulatory issues relating to your medical device
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We also offer additional support services such as:
- Importation
- Storage and warehousing
- Online regulatory training