Medical Device Registration Thailand

Medical Device Registration in Thailand

register your medical device products through License Holding without opening a local unit!

Register Medical Devices in Thailand and let us hold your license!
Protect your Intellectual Property and focus only on sales!

Medical Device registration at the Thai FDA is regulated by the new Medical Device Act issued in 2019, followed by the new Medical Device classification issued in 2021. The new medical device classification is risk-based instead of policy-based and makes the full process more accurate and strict.

Wiselink Group, with its internal Regulatory Department, guarantees a positive certification process (with a 100% positive score in medical devices), offering services as your license holder, Importer of Record, and product storage in an FDA-approved warehouse if you haven't registered your Thai Company yet or if this isn't in your plans.

Medical device registration at the Thai FDA follows different procedures based on device classification, which has drastically changed after the new Medical Device Act issued in 2019 and the enforcement of AMDD in 2021. Furthermore, since February 15th 2021, the transition period to ASEAN Medical Device Directive has begun, introducing new procedural requirements.

Wiselink Group guarantees fast registration at the Thai FDA for Medical Devices, Dietary Supplements, Hazardous Substances, Cosmetics, Food, Drugs."

Medical Device Registration in Thai FDA depends on many factors.
Let us plan them for you!

Listing Medical Devices

First step for the Medical Device Registration in Thai FDA is the establishment of a registered business place (import license). Then, lower risk class devices have a preferential lane for registration through e-submission. The latest Medical Device Act changed how FDA considers Medical Devices: now based on their risk class rather than function. The more complex the registration process becomes as the class level increases. Listing Medical Devices are now subject to CSDT like other classes and require approximately 4 months for registration.

Notified Medical Devices

All medical devices with active function (like magnetotherapy, ultrasound, etc) are considered Active Medical Devices and fall under Class 2 and 3. In the same class are grouped all the Class 2 risk A and B according to EU and USA regulation. A class II medical Device Registration in Thai FDA is done according to CSDT (Common Submission Dossier Template), standard across ASEAN and divided into 19 sections. Documentation is from February 2021, submitted according to AMD Directive explained in this article: Read more here.

Licensed Medical Device

For IVD (In Vitro Diagnostic) and normal Medical Devices, the new AMD Directive set up new rules for submission, summarized here: Read more here.

This category includes the highest risk Medical Devices; the procedure for submission includes a pre-check performed by the FDA to confirm the class, and the real assessment that normally lasts 200 days. Documentation can be submitted in two different phases, making the process smoother from a commercial perspective."

OUR STANDARD PROPOSAL FOR MEDICAL DEVICE REGISTRATION IN THAILAND

Wiselink Group registers your Medical Device Products in Thailand as your License Holder. Your company will be registered as Manufacturer upon presentation of relevant documents (normally ISO 9001, ISO 13485); Siam Trade shall be registered as Importer and will use its warehouse to be recorded as registered business place in Thai FDA for the Import License issuance.

After these steps have been achieved, Medical Devices shall be registered and labels created and sent electronically to the manufacturer; labels shall be applied to the external packaging before shipment.

After Medical Device registration process has been completed, we'll be allowed to import your products by obtaining an LPI (License per Invoice) from Thai FDA for each import procedure. After products have been stored in our warehouse, they can be handled directly by Wiselink Group according to your instructions.

A full process of Medical Device Registration takes approximately:
20 days for non-measurement class 1 devices,
4 months for measurement class 1 devices,
5 months for class 2 and 3 devices,
7 months for class 4 devices.

GENERAL GUIDELINES FOR MEDICAL DEVICE REGISTRATION IN THAILAND

For your convenience, we have listed the old directive below and added the latest update (dated March 2021) at this link here: THE READ 2021 REGULATORY UPDATE FOR MEDICAL DEVICES

Medical Device Registration in Thailand

Medical Device Registration in Thai FDA follows the guidelines given by the latest Medical Device Act 2019, enforced in November 2019.

The new law harmonized the Medical Device classification and registration process with international community and ASEAN CSDT (Common Submission Dossier Template).

Medical Device Registration Thailand Classification has drastically changed, and now every Medical Device is considered according to risk factor rather than by a mere division in classes. The new division into Active Medical Devices, non-Active Medical Devices, Invasive and non-invasive devices, etc. makes the classification completely different from before.

Basically, after CSDT has been imposed, classes are now 4, with subclasses depending on risk. On February 15th 2021, Thai FDA changed again the process of application in observance of AMDD (ASEAN Medical Device Directive).

According to your Medical Device risk classification (see article HERE), you will be addressed to different procedures.

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), 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:

1. Partial 1 Submission (Initial Documentation)
2. Partial 2 Submission (Supplementary Documentation)
3. Full Submission (Complete Documentation)

Update: From February 28th, 2024, the submission in Partial 2 won't be allowed anymore. Submission shall be possible only in Full process. See article HERE.

All applications are submitted electronically, which streamlines the operator's workflow and efficiency while requiring a high level of preparation.

From March 2024, the Concise evaluation and Reliance program 2024 provides shortcuts for your registration. Details at:
https://www.siamdevelopment.com/thai-fda-concise-program-for-medical-device-registration/

Thai FDA has prepared an e-consulting service reserved for accredited operators. To access it, each company must make a specific request to Thai FDA. A hotline has also been established to follow the procedures via telephone.

Wiselink Group can cover all the necessary steps for market entry: pre-market, license holding, import, warehouse, delivery (3PL) and compliance.

If, after obtaining a Medical Device License, you need to modify it, please refer to this article: https://www.siamdevelopment.com/possible-changes-in-thai-fda-medical-device-license/

Should you need an approved warehouse for Medical Device Import License purposes, please refer to this article for our warehouse units: https://www.siamdevelopment.com/warehouse-for-thai-fda-license/

News on GMP (updated June 2024):

Essential Licenses and Quality Certifications for Establishing a Medical Device Factory

TFDA Medical Device GDP: Thailand issues new regulation for Good Distribution Practices

Contact us now to request a quotation for your medical device registration.