IVDs in Thailand are classified into 4 categories (1 through 4) based on risk and closely follow ASEAN MDD guidance.
Factors affecting the risk include:
Purpose of use and indications
Expertise of the medical device user
Importance and Impact of the Medical Device Information on Individuals and Public Health.
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:
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) 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.
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.
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.
HIV test kits and COVID-19 test kits and its reagents require performance test certificates issued by a local laboratory.
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.