Thailand

Medical Device Registration in Thailand

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).

Guidance Document Name	Purpose	Link
Ministerial Regulations, Medical Device Products required Listing Approval	Outlines classification criteria for a Class 1, Listing category.	Thai
Ministerial Regulations, Medical Device Products required Notification Approval	Outlines classification criteria for a Class 2 or 3, Notification category.	Thai
Ministerial Regulations, Medical Device Products required License Approval	Outlines classification criteria for a Class 4, Licensing category.	Thai

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
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
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, 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	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 for Registering a Medical Device in Thailand

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. For more info on the Specialist Review process for medical devices, check out our blog here.

Risk Classification	Registration Type	Submission Fee	Specialist Review Fee (Novel Devices)	Approval Fee	Total Fee (with Specialist Review)	Max Review Time*
Class 1	Listing	500 Baht (US$ 17)	N/A	2,000 Baht (US$ 67)	2,500 Baht (US$ 84)	Auto-Approved
Class 2	Notification	1,000 Baht (US$ 33)	38,000 Baht (US$ 1,267)	10,000 Baht (US$ 333)	49,000 Baht (US$ 1,633)	250 days
Class 3	Notification	1,000 Baht (US$ 33)	38,000 Baht (US$ 1,267)	10,000 Baht (US$ 333)	49,000 Baht (US$ 1,633)	250 days
Class 4	Licensing	1,000 Baht (US$105)	53,000 Baht (US$ 1,767)	20,000 Baht (US$ 667)	74,000 Baht (US$ 2,539)	300 days

*Asia Actual’s experience is that actual review times are much shorter than the Max Review Time stipulated in the regulations. Please contact us for latest estimates.

Specialist Review Fees for License Adjustment
Classification	Non-IVD	IVD
Class 1	N/A	N/A
Class 2	24,000 Baht (US$ 800)	24,000 Baht (US$ 800)
Class 3	24,000 Baht (US$ 800)	24,000 Baht (US$ 800)
Class 4	30,000 Baht (US$ 1,000)	30,000 Baht (US$ 1,000)

Other Specialist Review Fees

Advertising

20,000 Baht

(US$ 667)

Justification

38,000 Baht

(US$ 1,267)

Expedited Market Access and Specialist Review Exemption Option

“Reliance Route”

In late 2021, the TFDA implemented the Reliance Route program allowing manufacturers to leverage their approvals by the Health Science Authority (HSA) in Singapore. Originally, only Class D applications qualified for this expedited review process but with a June 1st, 2022 announcement, the TFDA expanded the program to include all Class B, C, and D products approved by the HSA.

Qualifying applications must meet the following criteria:

CSDT documentation must be identical to those submitted in Singapore.
Applications will not be selected for an Expert Review (THB53,000 and extends review time by 1-3 months)
Review times will decrease from at least 150 days to a maximum of 60 days.

This process will require coordination with the Singapore Registrant as they will need to sign a Consent form allowing the HSA to share documentation with the TFDA. For more information on the Regulatory Reliance Route, please see our blog on the topic here.

“Concise Review”

The Concise Review is appealing to manufacturers of fairly novel devices that want to ensure they avoid the additional time and costs of a Specialist Review. The Concise route requires full CSDT and products must meet one of the following conditions.

1 approval in the Big 5 countries (USA, Canada, EU, Australia, Japan) and marketed for at least 3 years, or
2 approvals and above in the Big 5 countries and marketed for at least 1 year.

Products meeting these requiremetns won’t necessarily see a quick review of their application but it will ensure the application isn’t sent t a Specialist.

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 NBTC. 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 Using Asia Actual as Your 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.

Contact Us

US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Thailand@asiaactual.com

Frequently Asked Questions

Do I need to register my medical device in Thailand?

Yes, all medical devices must register before importing and marketing in Thailand. 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.

Who can submit submit applications in Thailand?

A local entity must submit applications, hold the license, and correspond with the TFDA. License Holders will then need to be part of the importing process. Using an independent license holder allows manufacturers to work with one company for importations and labeling.

How are products classified in Thailand?

How long does it take to register my medical device in Thailand?

The TFDA recently implemented new regulations in 2021 and therefore, the timelines are still new and haven’t been verified. However, official timelines are as follows:

Class A: 200 days
Class B and C: 250 days
Class D: 300 days

How much does it cost to register my device in Thailand?

Registration fees will consist of an Application fee, an Approval fee and a Specialist Review fee is selected by the review. These fees will vary from ~US$84 for Class A to US$2,500 for Class D if a Specialist Review is required. Please see our registration page for more information.

How long are medical device licenses valid in Thailand?

Does the license holder need to be a part of the importing process?

Yes, license holders will need to be a part of the importing process. License Holders will then need to be part of the importing process. Using an independent license holder allows manufacturers to work with one company for importations and labeling. To learn more about the license holder’s responsibilities, please see our page on the topic.

Is there an expedited review pathway?

Yes, there is currently an expedited review pathway for products registered in Singapore. Currently, this route is limited to Class D/4 devices but is expected to expand to other classes in the future. To learn more about this process, please see our blog on the topic.

Is ISO 13485 required for medical devices in Thailand?

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

Is Home Country approval required?

No, there are no requirements for home country or reference country approval though it is expected to help the expedite the review.

Do documents need to be translated to Thai as part of the application process?

Yes, some application documents will need to be translated including the Instructions for Use (IFU) and the labeling, especially for home use products. To learn more information about labeling requirements, please see our page on the topic.

Do advertisements need to be approved in Thailand?

Advertisements directed to, or available to, the general public, such as Direct to Consumer products, or ads to healthcare professionals available on social media will need prior approval before using. To learn more about these requirements, please see our page on the topic here.