Thai Medical Device Regulation 2021

THAI MEDICAL DEVICE REGULATION 2021: NEW THAI FDA RULES ON THE CLASSIFICATION AND REGISTRATION OF MEDICAL DEVICES

As announced in November and anticipated in a recent article, Thai FDA has implemented the new procedures for the registration of Medical Devices in Thailand. The new regulation entered into force on February 15, 2021 (Class 2,3,4) and March 17, 2021 (Class 1).

Source of the following information is the Thai FDA headquarters in Nonthaburi, at the Ministry of Public Health; it is not our policy to report information taken from the web.

Thai Medical Device Regulation: Categories of medical devices

The new Thai Medical Device Regulation is based on the risk factor, dividing the classification into 4 categories: 1. Low – 2. Low to Moderate – 3. Moderate to High – 4. High.

Therefore, the categorization of the medical device in Thailand is divided into:

In vitro medical device (IVD)
Non in vitro medical device

The latter are further divided into:

Non-invasive medical device
Invasive medical device
Active Medical Device
Additional rules

The 4 risk categories are then applied to each of these 4 categories and the medical device category is obtained, with the consequent application requirements.

Medical Device Registration Process in Thailand

The Medical Device registration process for all categories of medical devices falls within the guidelines established by the AMDD – ASEAN Medical Device Directive.

Procedure is based on the so called CSDT (Common Submission Dossier Template) already in use in the period 2018-2021, but with a substantial difference regarding the timing of submission of the documentation according to the practice indicated below:

Pre-submission, during which the risk classification and the Group to which the medical device belongs is assessed. The process takes a maximum of 15 days.

E-submission: once the classification and grouping of risks have been confirmed, applicants can proceed with the actual presentation of the dossier in three different ways:

Partial 1
Partial 2
Complete

Update on process (2024): Effective from February 15th 2024, Partial 1 and Partial 2 process are not possible anymore. All the application will follow the FULL CSTD process. See article here: https://www.siamdevelopment.com/thai-fda-medical-device-understanding-the-impact-of-partial-2-submission-termination/

All applications are now submitted electronically, making the operator’s work more comfortable on the one hand, but on the other it requires a high level of preparation.

Thai FDA has prepared an e-consulting service reserved to accredited operators: in order to access it, each company must make a specific request to Thai FDA. A hot-line was also set up to follow the procedures via telephone.

Thai Medical Device Regulation: Required documents

During the first phase (partial 1 and partial 2) the following documents are requested in abbreviated form:

Specific application form
Power of Attorney Appointing Business Operator including: (1) A copy of identification card and house registration of the grantor and the attorney. (2) Copy of house registration relevant places (Office, production site, import site, storage location). (3) Copy of the juristic person registration certificate (DBD certificate)
Device Label
Medical device documentation
Medical Device Executive Summary including: description of the medical device; history of the commercial activities of the medical device in the various countries including free sale certificate); any revocation of permits; status of registrations in the countries where registration is in progress; list of adverse events and FSCA reports; declaration about the use of animal or human cells, tissues or their derivatives, microbial derivatives, ionizing components.
Details of the Medical Device according to CSDT template
Indications for disposal at the end of use
Quality certificate of the product dealer (ISO or GMP)
Declaration of Conformity
Authorization letter for the importer

These are the documents for submission in Partial 2 procedure; Further documentation will be requested by Thai FDA after the process and registration has taken place. In the meantime, the registrant will be able to import and use the medical devices.

Timeline for the registration of medical devices

There are misleading information on many sites about the timing for registering medical devices in the various classes. This is the table of maximum times for obtaining a medical device license provided by the Thai FDA headquarters in Nonthaburi:

DEVICE CLASS	PRE-SUBMISSION	E-SUBMISSION		TOTAL TIME
		Dossier check	Process
1. listing	15 days	20 days	110 days	130 days
2. notified	15 days	40 days	120 days	160 days
3. notified
4. licensed	15 days	50 days	150 days	200 days

Costs for the registration of medical devices

The costs of the various stages of registration of medical devices have significantly decreased compared to the past. These are the rates of Thai FDA for the various phases:

Pre-submission: free
Dossier check: 1,000 THB
License process: 10,000 THB

Who can register a medical device in Thai FDA?

No change with regard to the ownership of the license, which must necessarily be registered in the name of a Thai company holding a warehouse approved by Thai FDA.

When a manufacturer wishes to hold the licenses in his own hands he will have two options:

Use a license holding service
Open a company in Thailand

Siam Trade Development can follow you in both ways, being your license holder or providing you with consulting and services for the management of your Thai company: domiciliation, representative office, certified warehouse, logistics services, accounting and temporary management.

Conclusion: what has changed in the Thai Medical Device Regulation?

Documentary wise, little has changed, although the timelines for submitting the dossiers are different from the past. The legislation is certainly now more precise in its classification (it was already so since 2018, but now the System is harmonized globally).

With regard of certification timeline for medical devices, there has been an increase of the procedure for category 1 (formerly class III). In the higher risk classes, the times are significantly reduced and the preparation of the dossier, being in two stages, is faster.

Costs: apart from the evaluation of the dossier, which went from 100 THB to 1,000 THB, the total cost of certification remains unchanged for the former class III and drastically decreases for the higher classes (from 63,000 THB to 10,000 for the former class II, for example).

The experience of your regulatory consultant will now be fundamental in terms of timing and costs, as the fewer revisions will be made, the less time and cost of the certification process will be.

If after you received a license you need any amendment, this is what you can do: https://www.siamdevelopment.com/possible-changes-in-thai-fda-medical-device-license/

On IVD classification:

Thai FDA IVD Risk Classification – IVD registration in Thailand

product registration thailand, Regulatory and Compliance, technical information