Thailand’s domestic medical device manufacturers generally only make basic medical products such as syringes and gloves; thus, the country is dependent on foreign imports for complex or high-end medical devices. This provides significant importation opportunities for Western medical device manufacturers.
If you are looking to register your medical device product in Thailand, Pacific Bridge Medical is here to help. Our regulatory consultants can help you through the Thai registration and licensing processes and secure approval for your medical device in the shortest possible time frame.
Read more about Thailand medical device registration requirements and application process by clicking on the following questions.
Which regulatory bodies in the Thai government are responsible for medical device registration in Thailand?
- The Thai Food and Drug Administration (TFDA) is the government agency in charge of regulating medical devices in Thailand.
- The Medical Device Control Division is the office of the TFDA specifically tasked with oversight of medical device affairs.
In Thailand, are medical devices required to be registered before they can be sold?
Yes, medical devices are required to be registered in Thailand before they can be sold.
What are the different regulatory classifications for medical devices?
- Category 1 – General Medical Devices
- Category 2 – Notified Medical Devices – Prior to importation, manufacturers and importers of the following devices must obtain a product Notification by the TFDA:
- Physical therapy devices
- Alcohol detector
- Implanted Silicone Breast Prosthesis
- Breast enhancement devices
- HIV test kit (the intended use must be for research studies not application)
- Category 3 – Licensed Medical Devices – Currently there are 7 devices in this stringently controlled category and all require TFDA approval:
- Examination gloves
- Surgical gloves
- Sterile hypodermic disposable syringes
- Sterile insulin disposable syringes
- HIV test kits for diagnostic use
- Contact Lenses
All manufacturers and importers of Category 1 & 2 devices mentioned above must obtain a product notification.
What does the registration pathway look like for licensed medical devices?
- The applicant must prepare seven required documents (see the list of required documents below) and ensure the Certificate of Free Sale and/or the Certificate of Quality System meets all the required criteria.
- Applicants must submit the required documents to the Thai FDA service center.
- The submitted documents are reviewed and recorded by a regulator of the Medical Device Control Division.
- A staff member records the applicant’s files into a database system. Then, the applicant is provided with a reference number and receipt.
- A regulator verifies the documents, if the all the submissions are correct and fulfill the required criteria, a letter for importation of general medical devices will be printed out on the back of copies of the Certificate of Free Sale. Upon signing off on all the documents, the regulator then submits the documents to the head of the Medical Device Control Division for final approval (this is generally the director or deputy secretary).
- The applicant obtains the letter of approval for importation.
Timeline: The entire registration process can take 3-6 months for approval depending on compliance with regulations. During step 6, if the device is incomplete and does not comply with TFDA regulations, the regulator is authorized to request a revision or additional documents. The applicant must then revise and resubmit their application.
What are the document requirements for notified medical devices?
- Applicant letter
- Application form
- An index for documents #1 – 13 on this list
- Characteristics of the medical device
- Packaging information
- Type and quantity components
- Intended use, warning(s), precaution(s)
- Instruction for use
- Storage information
- Test report
- Certificate of Free Sale
- Photo copy of trade or commercial registration, copy of census, a copy of the applicant’s ID card
- Device user manual
Timeline: about 3-6 months
What are the document requirements for general medical devices?
- A letter from company requesting to verify the Certificate of Free Sale.
- Two copies of the Certificate of Free Sale and/or Certificate of Quality System for manufacturer(s).
- A copy of the company’s registration (establishment documents) issued by the Ministry of Commerce within the six months stating the objectives of the company.
- Letter of authorization and certified copies of the local agent’s ID card must be attached. A letter of authorization is required in all instances.
- Product catalog or details of the product specified in the Certificate of Free Sale.
- Copy of the establishment for importation license.
- Detail of products in the Certificate of Free Sale indicating the medical device’s code. (The Thai FDA Handbook indicates the various codes associated with types of medical devices).
Additional documentation regarding the safety or intended use of the medical device may be required.
Timeline: about 3-6 months
Is local testing (type testing/sample testing) required for registration Thailand?
No, local testing is usually not required for registration in Thailand.
Are clinical studies required for registration?
No, clinical studies are generally not required for registration in Thailand.
Is approval in the Country of Origin required for registration?
Yes, approval in the Country of Origin is a requirement for registration in Thailand.
Contact us today for a free consultation on your specific needs with an expert in Thai medical device regulations and registration.
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