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IVD Device Registration in Thailand
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).
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:
- Executive Summary
- Device Description
- Intended use
- Instruction for use
- Storage condition
- Shelf life
- Potential adverse Effects
- Alternative Therapy
- Other Relevant specifications
- Other descriptive Information
- Device Labelling
- 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
- Risk Analysis
- 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||Purpose||Link|
|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||Thai|
|Ministerial Regulation: Notification Manufacture or Import Medical Device 2020||Outline requirements for Class 2 and 3 medical devices under the Notification Approval process||Thai|
|Ministerial Regulations, Medical Device Products required Listing Approval||Outline requirements for Class 1 medical devices under the Listing Approval process||Thai|
|Ministerial Regulations, Exemptions of document for New classification required Licensed Medical Device approval||Outline document exemptions during 3-year grace period for Class 4, Licensed applications.||Thai|
|Ministerial Regulations, Exemptions of document for New classification required Notification Medical Device approval||Outline document exemptions during 3-year grace period for Class 2 and 3, Notification applications.||Thai|
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.
|Risk Classification||Registration Type||Submission Fee||Initial Review Fee (Opt.)||Approval Fee||Total Fee||Est. Review Time|
|Class 1||Listing||500 Baht
|27,500 Baht (US$ 917)||200 days|
|Class 2||Notification||1,000 Baht
|49,000 Baht (US$ 1,633)||250 days|
|Class 3||Notification||1,000 Baht
|74,000 Baht (US$ 2,466)||250 days|
|Class 4||Licensing||1,000 Baht
|109,000 Baht (US$ 3,705)||300 days|
|Specialist Review Fees for License Adjustment|
|Class 1||19,000 Baht
|Class 2||32,000 Baht
|Class 3||44,000 Baht
|Class 4||63,000 Baht
|Other Specialist Review Fees|
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.
Thailand Regulatory Support
US: +1 512 898-9222