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.
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).
Guidance Document Name
Ministerial Regulations, Medical Device Products required Listing Approval
Outlines classification criteria for a Class 1, Listing category.
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:
Instruction for use
Potential adverse Effects
Other Relevant specifications
Other descriptive Information
Detailed Manufacturer Information
Essential Principles of Safety and Performance of Medical Device and Method Used to demonstrate conformity
Summary of Design verification and validation documents
Method of destruction
Quality Management Certification
Letter of Certification of the intended use/indication/ Package, Letter of certification of label and instruction for use from manufacturer or product owners
Declaration of Conformity
Letter of Confirmation for market history proof from manufacturer
Letter of Safety confirmation from manufacturer
Proof of approval from Medical Device Regulatory Authority in Foreign Countries
Letter of Authorization as Distributor for Manufacturer
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.
Guidance Document Name
Ministerial Regulations, Application for Permit and Issuance of License Manufacture or Import Medical Device, 2020
Outline requirements for Class 4 medical devices under the Licensing Approval process
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.
Class 1 (Listings)
Up to 200 Calendar Days
Class 2 and 3 (Notifications)
Up to 250 Calendar Days
Class 4 (Licenses)
Up to 300 Calendar Days
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.
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.
“The Thai FDA may require an Innovative Device Review for any General Medical device with which it is not familiar. This can add additional time and cost to what is otherwise the fastest registration process in SE Asia.”