SIAM TRADE DEVELOPMENT

Medical Device Registration in Thailand

Thai FDA registration for medical device products with or without License holding
No need 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 and stocking your products 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, has drastically changed.
Siam Trade Development guarantees a fast registration in Thai FDAfor all the class of products: 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!

Notified 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. Normally Medical Devices considered as Class 1 in EU and USA fall into this group, and are classified as class 3 or class 4.

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Class II Medical Devices

All medical devices with active function (like magnetotherapy, ultrasound, etc) are considered Active Medical Devices and goes in Class II. 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) similar in all ASEAN and divided into 19 sections. Documentation that must be presented in application is huge and must respond perfectly to Thai FDA requirements. Process time goes from 4 to 6 months.

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Consignment Procedure

In the last step of Medical Device Registration you can use the “consignment” procedure or submit your dossier to internal Thai FDA Commission. This is done to verify the respondence of manual, IFU, and labels to legal requirements. Internal Thai FDA Commission may take a couple of months to give you the green light. Consignment procedure is done through a specialist in the sector of Device under registration that endorse the device and guarantee its respondence to the requirements.

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 venue 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 1 month for a class 3 or 4, and above 4 months for a class 1 or 2.

GENERAL GUIDELINES 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.

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!