Medical device registration in Thailand

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.

Medical device registration in Thailand

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 national GDP. In export and import of medical device, Thailand is ranked in the first and second ranks compared within ASEAN countries.

Reasons for increase in demand for medical device 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 devices which are currently approved under the old regulations shall be renewed as per 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 following ASEAN MDD guidance, medical devices are classified into 4 categories. Class I, Class II, Class III, and Class IV.

CategoryRiskRegulatory process
Class ILow-riskListing (self-declaration)
Class IILow to Moderate-riskNotification (CSDT)
Class IIIModerate to High-riskNotification (CSDT)
Class IVHigh-riskLicense (CSDT)

Similarly, IVDs in Thailand are classified into 4 categories based on risk and closely follow ASEAN MDD guidance.

Conformity assessment 

  • 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 1 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 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 manufacture or import of the medical device.
  • The sponsor can apply Establishment License via manual submission and once approved it will be issued by the Thai FDA. 
  • 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
    • Appoint a local distributor
    • Appoint an independent third party
  • The holder of Importer License may then proceed to register the medical device with the Thai FDA.
  • All medical device registrations in Thailand must be submitted 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.
  • Once payment is received, 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
    • License.
  • However, if the Thai FDA may consider that the documentation does not meet the requirements and thereby request additional documentation.
  • The Thai FDA will evaluate the submission again, and if successful an authorization will be provided or if not, then may reject the submission.

Validity of medical device approval

The approval of all medical devices is valid for 5 years. Medical Devices need to be renewed 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 device classification. Below is the table which lists out the fee and timelines for various devices class.

Risk ClassificationRegistration TypeApproval FeeMax Review Time*
Class IListing3,100 Bhat200 days
Class IINotification31,000 Bhat250 days
Class IIINotification31,000 Bhat250 days
Class IVLicensing51,000 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 and it costs about US$200.
  • 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.

Local importer

  • 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

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