Medical Device Registration in Thailand

Medical Device Registration in Thailand

Medical Device registration in Thailand: register your medical device products with License Holding without opening a local unit!

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

Medical Device registration in 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.

Siam Trade Development, with its own internal Regulatory Department, guarantee you a positive certifcation process (we have a 100% positive score in medical devices), 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.

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.

Business License

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  MEDICAL DEVICE REGISTRATION IN THAILAND

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; labels shall 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.

QUESTIONS AND ANSWERS

Medical Device Classification in Thailand is risk-based, as per ASEAN Directive received in 2018 and fully applied from 2021.

According to its function, use, time and risk, a medical device may be classified in 4 categories, numbered from 1 to 4, with a related risk class (16 different rules). According to the result of such assessment, certification process will have different requirements.

Medical Device Classification in Thailand

You can download here the FULL DOCUMENTATON explaining the risk-based Medical Device Classification in Thailand. Documents are our translation of the official rules issued by Thai FDA. They have mere descriptive purpose and are not aimed at professional use. Contact us for any official assessment about classification of your Medical Device.

Download the document Thai FDA Medical Device Classification

Download the document Medical Device Risk Classification in Thai FDA

Medical Devices risk classification are clearly stated in the official documentation issued in 2021, following the new regulations issued in 2021.

Since then, we receive from new customers always the same question: what is the risk classification of my medical device? We summarize here below the cornerstone of Medical Devices risk classification, so that every manufacturer/importer may be able to understand his own medical device.

Following documents have been elaborated by us from the official source (Thai FDA). PDF is available for download HERE and it’s available in Chinese language HERE.

WHICH CLASS IS MY MEDICAL DEVICE IN THAILAND?

Classification of Medical Devices in Thailand depends mainly on their risk factor. Other criteria are the medical device usage, if invasive, active, or other, and many other factors that we grouped in the PDF you can safely download here

DOWNLOAD FILE Medical Devices Risk Clasification in Thai FDA

Note: the file is not for professional use and is just for divulgative purpose. Only Thai FDA pre-assessment can give the garantee of a correct classification. Contact us for an official assessment.

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

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 drastically 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.

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

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

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
  2. Partial 2
  3. Complete

All applications are 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.

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!