Government Authority

Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA). The regulatory process is based on the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2). New regulations recently went into effect on February 15, 2021, bringing closer alignment with the ASEAN Medical Device Directive (AMDD).

Medical Device Status

Products that make therapeutic, medical or dental claims are considered Medical Devices in Thailand including aesthetic devices and software as a medical device. Medical Devices with a drug component may be registered as a pharmaceutical.

Product Categorization

Products in Thailand are classified into 4 categories (1 through 4) based on risk and closely follow ASEAN MDD guidance. Guidance for classifying products according to Annex 2 of the ASEAN MDD but additional guidance and Thai specific rules can be found here (English translation to come soon).

Device Conformity Assessment

Medical devices will be required to undergo one of three registration routes to acquire an Import License depending on their classification. Class 1 products will require a Listing, Class 2 and 3 will require a Notification and Class 4 (highest risk) will require a License. Conformity Assessments under the new regulations will require applications for Class 2-4 products be submitted in the Common Submission Dossier Template (CSDT) format while Class 1 Listed products require less documentation. An Establishment License issued by the Thai FDA of the local registrant and license holder is also required.

Components of CSDT applications include:

1. Executive Summary
   1. Device Description
   2. Intended use
   3. Indications
   4. Instruction for use
   5. Storage condition
   6. Shelf life
   7. Contradictions
   8. Warnings
   9. Precautions
   10. Potential adverse Effects
   11. Alternative Therapy
   12. Materials
   13. Other Relevant specifications
   14. Other descriptive Information
2. Device Labelling
3. Detailed Manufacturer Information
4. Essential Principles of Safety and Performance of Medical Device and Method Used to demonstrate conformity
5. Summary of Design verification and validation documents
6. Risk Analysis
7. Method of destruction
8. Quality Management Certification
9. Letter of Certification of the intended use/indication/ Package, Letter of certification of label and instruction for use from manufacturer or product owners
10. Declaration of Conformity
11. Letter of Confirmation for market history proof from manufacturer
12. Letter of Safety confirmation from manufacturer
13. Proof of approval from Medical Device Regulatory Authority in Foreign Countries
14. Letter of Authorization as Distributor for Manufacturer
15. Grouping indication letter

Some products (high risk IVDs, gloves, etc.) may require in-country testing and will be determined on a case-by-case basis.

Specific documentation requirements for each application route, as well as transition period exemptions are listed below.

Fees and Timelines

As the regulations only recently went into effect, the timelines are based on formal guidance documents and not Asia Actual’s experience. This information will be updated as more registrations are issued under the new guidance. Government Fees are also still under review and may change.

Quality Systems Conformity Assessment

Class 2-4 devices all require ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.

Validity and Renewal

Once approved, all types of Registrations Licenses are valid for 5 years. Registration Renewals are less expensive than initial registration applications for Class 1 Listings but are currently set to be the same fee as the initial registrations for Class 2-4 but could change. Products registered under the old rules will be permitted to renew one time with a partial application before undergoing a full registration once the renewed license expires 5 years later. Documents required for partial applications vary depending on the renewal date.

Wireless Technology Licensing

Medical device that contain wireless technology such as cellular, WiFi or Bluetooth are subject to regulatory review by the MBTC. Government review requires 30 to 45 working days and US$200. This licensing is independent from any Thai FDA regulatory requirements, and can be done before, during or after medical device licensing; but must be in place prior to importation.

License Holder Requirements

Import Licenses are issued to a local, licensed company that will own and control the license. Currently, the Thai regulations do not provide for the transfer of licenses between holders. However, foreign manufacturers may have multiple license holders for the same device at the same time.

License Transfer

The Thai regulations do not provide for the transfer of Import Licenses issued under the old Rules.  Going forward, holding responsibilities for Licenses, Notifications, and Listings under the new Rules are expected to be transferable, but no guidance is yet available.

Benefits of Independent License Holder

• Sell directly to multiple regional distributors, avoiding mark-up by a national importer
• Increase transfer pricing
• Improve leverage in distributor negotiations/responses
• Add or change distributors as required
• Keep intellectual property away from local commercial agents
• Assure expert handling of  post market vigilance and license maintenance

It is advisable to consult with a local expert to confirm the regulatory requirements for your specific decides.

Contact Asia Actual with questions or a request for support in Thailand. Asia Actual has a fully licensed offices in Bangkok staffed by experienced, bi-lingual regulatory and commercial professionals to offer medical device registration, independent license holding, importing and sales support services in Thailand.