Registration of Medical Devices for Clinical Trials
Medical Devices under Clinical test and not for sale in Thailand can enjoy a preferential lane and being imported without FDA License
In some cases Medical Devices need to enter in Thailand with the sole scope of Clinical Trials or laboratory Teste. This may be done in a single batch or in multiple import, without the burden of getting a Medical Device license in Thai FDA.
The process is shorter and less expensive, although the documentation, in case of consumables and notified Medical Devices, is quite similar. Of Course, in case of class II and ! Medical Devices a Clinical Trial in Thailand will be beneficial for a subsequent Commercial License Registration and make the full process easier.
In any case only a Thai Licensed Company (with an import license for Medical Devices) is authorized to ask for this procedure. The same Company shall be responsible for any damage caused by the device and shall certify the disposal (or the re-export) of the tested equipment.
Siam Trade Development services
Need to process Clinical Trials in Thailand for your Medical Devices? We can import your products and manage the test locally!
File Preparation and MOU with a Scientific Institute
In order to process the Registration of Medical Devices for Clinical Trials in Thailand we will need first a Power of Attorney from the manufacturer and a proper MOU (Memorandum of Understanding) with an accredited institute for the performance of Clinical Trials. The Agreement must report in detail the scope of the research, the medical device used and many other details.
Submission to Thai FDA of your Medical Device files
After your MOU has been signed and you gave us your POA, we will collect all the documentation and prepare a file that can be used multiple times for different Temporary Import License for your Medical Device (but every time we must get a new authorization from Thai FDA!). After the submission, in a straightforward case the Import Authorization will be issued within 14 days. Further documentation may be asked by FDA.
Import and execution of Clinical Trial
Once the Medical Device Import Permit has been received, we will submit the shipping documents (packing list, commercial invoice, AWB or B/L, to Thai FDA in order to receive the License per Invoice (LPI), the final authorization to import the batch in subject into Thailand. After the medical device has been used for testing, it must be sent to the origin or disposed by an accredited company,
OUR STANDARD PROPOSAL FOR the Registration of Medical Devices for Clinical Trials
Siam Trade Development will be your Authorized Importer by Power of Attorney and will work in strict connection with your chosen institute for Trials. Your products will be registered under Siam Trade Development name, that will be de facto your marketing authorized holder (only for trials).
We will require a set of documents about the Medical Device you want to import; in this case Free Sale Certificate and other Standard Certifications are not required. For this reason, your product won;t be authorized for sale, but only imported for scientific purposes.
Siam Trade Development will take care of the application and relationship with Thai FDA and, after the Import Permit has been released, will take care of custom clearance and deliver to your insitute that will run the tests/trials.
After product has been used it will be our care to ship it back if resuable, or dispose it if consumable. We take care of everything on your behalf!
GENERAL GUIDELINES FOR TEMPORARY IMPORT
of Medical Devices for Clinical Trials in Thailand
The waiver for importing general medical devices Can be done by applying for a waiver at the Medical Device Control Division, or directly to a Custome Facility according to the cases below:
CASE 1, Submitting an application for an import waiver at the food and drug checkpoint at Custom during the import of equipment
This can be done by:
Physicians: a physician who does not need to be licensed under Section 12 and does not have to declare the details under Section 16 as follows:
- For personal use
- To illustrate the exhibition
- for example products
- For use in the teaching of educational institutions.
Agencies and Government agencies: For prevention, diagnosis, treatment, or rehabilitation Or the Thai Red Cross Society Which Government agencies Or the Thai Red Cross Society to certify quality, standards, efficiency and The safety of the medical devices brought into it.
Importing a medical device by a public or private medical facility With a certificate of introduction:
- Access to other medical devices approved by the Food and Drug Administration.
- Bringing into a new medical device After sending it for repair abroad
- Bringing medical devices to repair and send them back outside the Kingdom
- Repatriation For medical devices still in love with Customs Department
CASE 2, Submitting an application for import waiver at the Medical Device Control Division Office of the THAI FDA
For importing into a medical device In the following cases
- Medical devices that are components, fittings or parts in the machine manufacture Medical hand or used in the production of drugs. By a licensee to manufacture drugs in the country
- Import of Medical device for clinical research
- Medical devices for research, analysis or quality testing.
- Bringing into a donated medical device
- Import of a medical device for sale to a government agency in the duty of preventive examination.