In Thailand, the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA) oversees the medical device registration process. This regulatory framework is guided by the Medical Device Act B.E. 2551 (2008) and further updated by the Medical Device Act/ Ordinance B.E. 2562 (2019) (Issue 2). Recent regulatory revisions, effective February 15, 2021, align more closely with the ASEAN Medical Device Directive (AMDD).
Thailand’s medical device registration process requires adherence to stringent standards set forth by the MDCD. Manufacturers seeking market approval must meticulously prepare documentation and ensure compliance with regulatory requirements. The MDCD conducts thorough evaluations to assess the safety, quality, and efficacy of medical devices before granting registration.
Upon successful completion of the registration process, manufacturers receive approval from the MDCD to market and distribute their medical devices in Thailand. It is essential for companies exporting products to Thailand to understand and comply with these regulations to facilitate seamless entry into the Thai market.
Continuous monitoring and compliance with post-registration requirements are imperative to maintain market authorization and ensure the ongoing safety and efficacy of medical devices in Thailand. By navigating the medical device registration process in Thailand effectively, manufacturers can access a thriving market and contribute to improving healthcare standards in the region.
In Thailand, medical devices are categorized into four classes (1 through 4) based on the level of risk, closely aligned with ASEAN MDD guidance. While Annex 2 of the ASEAN MDD provides general classification criteria, additional Thai-specific rules are available. Below are key guidance documents outlining classification criteria for each category:
| Guidance Document Name | Purpose | Link |
|---|---|---|
| Ministerial approval needed for listing medical devices. | Defines criteria for Class 1, Listing. | Thai |
| Ministerial Regulations mandate Notification Approval for Medical Devices. | Specifies criteria for Class 2 or 3, Notification category. | Thai |
| Ministerial Regulations mandate License Approval for Medical Device Products. | Defines criteria for Class 4, Licensing category. | Thai |
These guidance documents provide essential information for companies seeking medical devices registration in Thailand, ensuring compliance with local regulatory standards.
Requirements for registering medical devices in Thailand entail various documentation submissions, all to be prepared in English. Essential documents include a detailed device description, pre-clinical study data, labeling, usage instructions, risk analysis, and evidence of compliance with ISO 13485 standards.
It’s worth noting that specific medical devices may necessitate additional permits from the Thai FDA or other government bodies. This is especially true for devices involving radiation or wireless connectivity. Additionally, certain products may require testing in accredited Thai laboratories to ensure compliance with local regulations.
Ensuring compliance with Thailand’s medical device registration process is vital for companies seeking market access in the country. By meticulously preparing and submitting the required documentation, manufacturers can navigate the registration process smoothly and efficiently.
| Risk Classification | Class 1 | Class 2 / Class 3 | Class 4 |
|---|---|---|---|
| Registration type | Listing | Notification | Licensing |
| Submission Fee | 500 Baht (US$ 17) |
1,000 Baht (US$ 33) |
1,000 Baht (US$33) |
| Specialist Review Fee (Novel Devices) | N/A | 38,000 Baht (US$ 1,267) |
53,000 Baht (US$ 1,767) |
| Approval Fee | 2,600 Baht (US$ 87) |
10,000 Baht (US$ 333) |
20,000 Baht (US$ 667) |
| Total Fee (with Specialist Review) | 3,100 Baht (US$ 104) |
49,000 Baht (US$ 1,633) |
74,000 Baht (US$ 2,539) |
| Max Review Time | 1 – 8 days | 250 days | 300 days |
Each medical device registration in Thailand incurs a fee, which is classified as non-tax. The following outlines the updated fees effective March 2021, along with the corresponding turnaround times for e-submissions.
Following approval, all types of Registration Licenses remain valid for a duration of 5 years in Thailand. Renewal procedures are available for Class 1 Listings, offering a more cost-effective option compared to the initial registration applications. However, for Class 2-4 listings, renewal fees are currently aligned with those of initial registrations, with the potential for changes in the future. Products registered under previous regulations are granted one renewal opportunity through a partial application before necessitating a full registration upon expiration of the renewed license, five years later. Specific documentation requirements for partial applications are contingent upon the renewal date.
Trust Maven for your medical devices registration needs in Thailand. Our comprehensive services ensure a smooth and efficient registration process, allowing your products to enter the Thai market seamlessly. With our expertise, you can navigate the complexities of medical device registration in Thailand with confidence. Let Maven be your partner in achieving compliance and success in the Thai market.
