Question 1

What is Thai FDA and why is it important for medical device companies?

Accepted Answer

Thai FDA (Thai Food and Drug Administration) is Thailand's national regulatory authority for food, drugs, and medical devices under the Ministry of Public Health (MOPH). The Medical Device Control Division (MDCD) regulates medical devices under the Medical Device Act B.E. 2551 (2008) and its 2019 amendment (B.E. 2562). All medical device companies must obtain Thai FDA approval and maintain compliance to sell products in Thailand's growing medical device market.

Question 2

What is the auto-approval process for Class 1 devices?

Accepted Answer

Starting January 15, 2025, Thai FDA implemented an auto-approval process for Class 1 medical devices. Once manufacturers submit required data and fees, a registration number is issued automatically without manual review. Thai FDA maintains a "Positive List" of Class 1 devices qualifying for this fast-track process, significantly shortening registration timelines for low-risk products while maintaining safety standards.

Question 3

How are medical devices classified in Thailand?

Accepted Answer

Thailand classifies medical devices into 4 categories (Class 1-4) based on risk, closely following ASEAN MDD (Medical Device Directive) guidance. Registration routes vary by class: Class 1 (lowest risk) requires Listing (with auto-approval option), Class 2-3 require Notification, and Class 4 (highest risk) requires full License approval with extensive technical documentation.

Question 4

What are the latest labeling regulation changes?

Accepted Answer

On March 18, 2025, MOPH released draft amendments to 2020 labeling regulations (B.E. 2563) to align with the Medical Device Act B.E. 2551 and 2019 amendments. The updates clarify criteria, methods, and conditions for labeling and Instructions for Use (IFU) documentation, strengthening consumer protection and harmonization with international standards. Additionally, new advertising regulations effective January 4, 2025 introduced stricter oversight and prohibition of misleading claims.

Question 5

What is a Local Authorized Representative and do foreign manufacturers need one?

Accepted Answer

A Local Authorized Representative (LAR) is a Thailand-based legal entity required for foreign medical device manufacturers. The LAR acts on behalf of the manufacturer in all regulatory interactions with Thai FDA, including device registration, import licensing, post-market surveillance, and compliance activities. All foreign companies must appoint an LAR to register and sell medical devices in Thailand.

Question 6

How can I stay updated on Thai FDA regulatory changes?

Accepted Answer

This page automatically aggregates Thai FDA and Thailand medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, Asia Actual, and others. Pure Global provides comprehensive regulatory support for Thailand market access.

Question 7

What sources does this Thai FDA news page aggregate from?

Accepted Answer

We aggregate Thailand and Thai FDA news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Pacific Bridge Medical, Emergo by UL, Asia Actual, Citeline MedTech Insight, Pure Global's proprietary Thailand research team, and Qualtechs. All sources are filtered to show only Thailand-related regulatory updates using advanced keyword matching including Thai FDA, MOPH, Medical Device Act, and Thailand-specific terminology.

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