Medical devices are regulated by the Medical Device Control Division (MDCO) from the office of Food and Drug Administration (FDA) in Thailand (also known as Thai FDA). Recently the Thai FDA has made many changes in regulatory requirements and approval process for medical devices.
Medical device market
The medical devices industry is one of the high-potential sectors in Thailand. In 2019, the medical device sector accounted for 4.47 percent of the national GDP. In the export and import of medical devices, Thailand ranks first and second among ASEAN countries.
Reasons for the increase in demand for medical devices in Thailand
- Increasing size of the geriatric market due to aging population.
- The rebound of foreign patients seeking treatment.
- Support from the government to promote Medical Tourism.
Regulatory authority for medical devices in Thailand
The Medical Device Control Division (MDCD) is the office of the Thai Food and Drug Administration (FDA) oversees the medical device regulations in Thailand.
Thai FDA recently released new regulations which were effective from February 15, 2021. The manufacturers or sponsors who obtained medical device approval under the old regulations shall renew approval as per the new regulations.
Medical device definition in Thailand
Products that make therapeutic, medical, or dental claims are considered medical devices in Thailand including aesthetic devices and software as medical devices. Medical devices with a drug component may be registered as a pharmaceutical.
Medical device classification in Thailand
Based on risk and ASEAN MDD guidance, medical devices are classified into four categories. Class I, Class II, Class III, and Class IV.
|Class I||Low-risk||Listing (self-declaration)|
|Class II||Low to Moderate-risk||Notification (CSDT)|
|Class III||Moderate to High-risk||Notification (CSDT)|
|Class IV||High-risk||License (CSDT)|
Similarly, IVDs in Thailand are classified into four categories based on the risk and closely follow ASEAN MDD guidance.
- To market and import a medical device into Thailand, Medical devices needs to undergo one of three registration routes (as given in the above table) to acquire an Import License depending on their classification.
- Class-I medical device requires less documentation.
- The low-risk Class-I devices must be listed before they are imported and marketed in Thailand,
- The Class I sterile and measuring devices require submission of testing reports for placing these devices on the market.
- Whereas the Class II and Class III devices have to be notified and the Class IV devices must have an approved license to place in the Thai market.
- The Class II, III, and IV devices require submission of a technical dossier, as per ASEAN CSDT format. Also, Class II, III, & IV devices require ISO 13485 certificates to certify the quality system of the legal and/or actual manufacturing facilities.
Requirements for registration of medical device in Thailand
- The language for the submission could be in English.
- Dossier requirements
- Device description,
- Pre-clinical studies,
- Device labelling,
- Instructions for use,
- Risk analysis and any existing regulatory approvals or market authorisations, and
- Manufacturer compliance for ISO 13485.
- Certain medical devices require separate Thai FDA permits or registrations from other Thai government agencies such as those which contain or transmit radiation and those with wireless connectivity, and
- Some specific medical products may need local testing in an accredited laboratory in Thailand.
Steps to register medical devices with the Thai FDA
- In order to register a medical device in Thailand, a company must first obtain an Establishment License for the manufacture or import of the medical device.
- The sponsor can apply for Establishment License via manual submission and the Thai FDA issues it.
- Currently, only people of Thai nationality or local established companies can apply for an Establishment License.
- Foreign manufacturers have three possibilities to register their medical device in Thailand:
- Set up a legal subsidiary entity in Thailand, or
- Appoint a local distributor, or
- Appoint an independent third party.
- The holder of Importer License may then proceed to register the medical device with the Thai FDA.
- Applicant can submit all medical device registrations in Thailand online via the Pre-submission and E-submission system.
- Once the necessary documentation has been submitted 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.
- After receiving payment the Thai FDA will start to evaluate the documents.
- If all documents meet Thailand’s medical device registration requirements, then the Thai FDA will issue the
- Listing Certificate,
- Notification Certificate or
- However, the Thai FDA may consider that the documentation does not meet the requirements and thereby request additional documentation.
- The Thai FDA evaluates the submission once again. If successful, if successful may provide authorization or if not, they may reject the application.
Validity of medical device approval
The approval of all medical devices is valid for 5 years. Th approval holders need to renew before the expiration date with partial applications but once the renewal date expires, requires full registration. Documentation requirements vary for partial applications depending on the renewal date.
Review fee and timelines
The fee and timelines vary depending on the medical device classification. Below is the table which lists the fee and approval timelines.
|Risk Classification||Registration Type||Approval Fee||Max Review Time*|
|Class I||Listing||3,100 Bhat||200 days|
|Class II||Notification||31,000 Bhat||250 days|
|Class III||Notification||31,000 Bhat||250 days|
|Class IV||Licensing||51,000 Bhat||300 days|
Medical devices with wireless technology capabilities
- Medical devices that use wireless technology such as cellular, WiFi, or Bluetooth are subject to regulatory review by the Office of The National Broadcasting and Telecommunications (MBTC). It takes 30 to 45 working days for the government to review. It costs about US$200 for processing the application.
- The sponsor can obtain a license for this wireless technology before, during, or after medical device licensing; but must be in hand prior to importation.
- To import medical device into Thailand, a foreign manufacturer need to appoint a local importer.
- The Thai FDA issues Import licenses to a local, licensed company that will own and control the license.
- A license holder also requires an establishment license issued by the Thai FDA.]
Looking for regulatory support for your medical device in Thailand
Talk to us today. Provide preliminary details below and we will help you achieve a successful registration in Thailand. Credevo can be your strategic partner to make a successful submission in a timely manner. You will get a complete overview of the regulatory framework, process overview, and timelines associated with submissions.