SIAM TRADE DEVELOPMENT

Medical Device Registration in Thailand

Thai FDA registration for medical device products with License Holding or opening a local unit

Medical Device Registration in Thailand

Register Medical Device in Thailand and let us hold your license!
You only have to care your sales!

Thanks to its internal Regulatory Department, Siam Trade Development provides your Medical Device registration in Thai FDA, with the added value of being your license holder, your Importer of Records  and stocking your products in a FDA approved warehouse if you don’t have your Thai Company registered yet or if this is not in your plan.
Medical Device products registration in Thai FDA has different procedures according to the classification of the device that, after the new Medical Device Act issued in 2019 and the enforcement of AMDD in 2021, has drastically changed. Furthermore, from February 15th 2021, the transition period to ASEAN Medical Device Directive started, and new procedures have been imposed in the process.
Siam Trade Development guarantees a fast registration in Thai FDA for all the 4 classes of Medical Devices, Dietary Supplements, Hazardous Substances, Cosmetics, Food and Drugs.

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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 so-called “registered business place”, known also as “import license”. Then, lower risk class devices have a preferential lane for the registration through e-submission. The latest Medical Device Act changed the way FDA considers Medical devices: not anymore according to their function but according to their class of Risk. The higher the class is, the harder the job. Listing Medical Devices are now subject to CSDT like other classes and take around 4 months to be registered.

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Notified Medical Devices

All medical devices with active function (like magnetotherapy, ultrasound, etc) are considered Active Medical Devices and goes in Class 2 and 3. In the same class are grouped all the class 2 risk A nd 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) same in all ASEAN and divided into 19 sections. Documentation ism from february 2021, submitted according AMD Directive explained in this article: READ HERE

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Licensed Medical Device

For IVD (In Vitro Diagnostic) and normal Medical Devices the new AMD Directive set up new rules for submission, that are summarized here: READ THE ARTICLE.

This category includes the highest risk Medical Devices; the procedure for submission includes a pre-check performed by 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 on commercial point of view.

OUR STANDARD PROPOSAL FOR REGISTRATION OF MEDICAL DEVICE PRODUCTS

Siam Trade Development register your Medical Device Products in Thailand being 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 recorder as registered business place in Thai FDA for the Import License issuance.
After these steps has been achieved, Medical Devices shall be registered and label created and sent electronically to the manufacturer; They’ll be applied to the external packaging before shipment.
After Medical Device registration process has been finished we’ll be allowed to import your products simply receiving a LPI (License per Invoice) from Thai FDA at every import procedure). After product has been stored in our warehouseit can be  handled directly by Siam Trade Development according to your indications.
A full process of Medical Device Registration takes around 4 months for a class 1 device, 5 months for class 2 and 3 devices, and 7 months for class 4 devices.

GENERAL GUIDELINES FOR MEDICAL DEVICE REGISTRATION IN THAILAND

For your convenience we leave the old directive listed below and add the latest updated (dated march 2021) at this linke here: READ THE 2021 REGULATORY UPDATE FOR MEDICAL DEVICES

OLD rules for 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.

Medical Device Registration Thailand Classification drasticall changed, and now every Medical Device is considered according to risk factor and not by a mere division in classes. The new division in Active Medical Device, non Active Medical Devices, Invasive and non-invasive, etc makes the classification completely different than before.

Basically, after CSDT has been imposed, classe 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. We will deepen this topic in a successive New you will be able to read in our blog section very soon.

Generally speaking a class I in Europe/USA shall be considered class III in Thailand, and vice-versa a class III shall be class I in Thailand. We suggest a regulatory pre-check before any decision in pre-market assessment.

Consequently, the required documentation changes according to classification. Class III is generally easier and more a matter of communication and explaination of the device, while a class II (generally active and invasive devices) require a strong and complete documentation, including clinical studies and reports.

Time frame also vary from 3 weeks for Generic Medical Devices to 4/6 months for a class II

Medical Device registration procedure

In thai FDA you have two options for the registration of class I and II Medical Devices: submission or consignment. This means that the registrant has to decide if using Thai FDA commission for evaluating the Medical Device or if he prefers the self-assessment by using his own specialist; in this case must be a Thai Doctor Specialist in the sector of the Device under registration.

Following the obtained certification for the device, an advertisement license shall be required in order to promote the device on the market (media, Internet, and also brochures).

A Medical Device license shall be valid until Free Sales Certificate expiration in Class III and for three years for Class I and II.

Siam Trade Development can cover all the necessary step for market entry: pre-market, license holding, import, warehouse, delivery (3PL), and compliance.

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

MEDICAL DEVICE REGISTRATION THAILAND

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Summary
Medical Device Registration Thailand
Service Type
Medical Device Registration Thailand
Provider Name
Siam Trade Development,
Two Pacific Place, 142 Sukhumvit Road, 14th floor, Suite 1406,Bangkok,Thailand-10110,
Telephone No.+66830314030
Area
Thailand
Description
Medical Device Registration in Thailand - Thai FDA registration for medical device products with or without License holding - No need a local unit!