Thai Regulations on Medical Devices
Medical Device Control in ThailandMedical Device Control Division , Thai – Food and Drug Administration, is an organization which regulates and monitors Quality, Standard, Efficiency and Safety of medical devices manufactured, imported and sold in Thailand abide by Medical Device Act B.E. 2551 ( A.D. 2008 ), Ministerial Regulation and Notice of The Ministry of Public Health.
Importing of General Medical Devices
Required documents for importing of general medical devices are
- A letter from company requesting to verify the Certificate of Free Sale.
- Original document of the Certificate of Free Sale and / or Certificate of Quality System for manufacturer(s) with two photocopies.
- Copy of the company’s registration issued by the Ministry of Commerce within the six months stating the objectives of the company.
- Letter of authorization with 10 baht in revenue stamps for one-off contact or 30 baht for one year multiple re-contacts. Certified copies of authorizer’s and attorney’s ID card must be attached. A letter of authorization is required in all instances.
- Product catalogue 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 medical devices’ code. The code is stated in the 2545 Thai FDA Handbook of codes and types of medical devices.
Note : When necessary, additional documents to support the intended use or safety data may be submitted for verifying process.
The following process are required when importing of general medical devices.
- Importers prepare all seven required documents above and check whether the Certificate of Free Sale and / or the Certificate of Quality System. For manufacturer (s) is in accordance with the criteria or not.
- Importers must submit documents at the one stop service centre, Thai FDA.
- The submitted documents are checked by regulator of the Medical Device Control Division and the results are recorded.
- A staff records initial information in computer system then gives the applicant a reference number and a receipt.
- A regulator verifies documents if all is correct, a letter for importation of general medical devices will be printed out on the back of copies of the Certificate of Free Sale, stamps and signs on each page of each copies, then submits for approval to head of section, division director and deputy-secretary general, respectively. If any item does not comply to regulation or incomplete, regulator are authorized to cross out that item. Additional submissions for these items can be done later.
- Importers can get the letter for importation within the time table as set for each procedure.
Licenses Medical Devices
Devices those require premarket approval. They are the most stringently controlled class. At present ,7 items are classified into this class as follow ;
- Examination gloves
- Surgical gloves
- Sterile Hypodermic Disposable Syringes
- Sterile Insulin Disposable Syringes
- HIV Test Kits for Diagnostic use
- Contact Lens
All manufacturers and importers of devices mentioned above must obtain a product licence or licences issued by the Thai Food and Drug Administration before manufacturing or importation. The manufacturers and importers of HIV Test Kits for Diagnostic use must hold a quality control accreditation. Besides, the distributor and the seller of it must obtain a premise of HIV Test Kits for Diagnostic use licence .
Notification Medical Devices
This group of medical device composes of
- Physical therapy products
- Alcohol Detector
- Implanted Silicone Breast Prosthesis
- Breast enhancement
- HIV test kit (for researching and studying) which not for registration
All manufacturers and importers of devices mentioned above must obtain a product Notification by the Thai food and Drug administration before manufacturing or importation.
Request for Establishment License
The Medical Device Act A.D. 2008 requires that any person who wishes to manufacture or import medical devices into the Kingdom must obtain a establish licence from the General Secretary of Food and Drug Administration
“Import” means importing or ordering into the Kingdom.
“Manufacture” means make, assemble, invent, repackage separately or collectively, improve, modify or sterilize
Applications and approvals for establishment licences are to be conducted in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulations.
The purpose of Post-Marketing Control is to ensure that medical devices distributed to consumers are wholesome and have quality that complies with the medical device standards. As a result, this measure deals primarily with the activities of enforcement. Inspection of all medical device factories and premises throughout the country is conducted regularly, together with the sampling of products for analysis and assaying to ensure compliance with legal requirements. Market surveillance is performed in an all-year-round manner, including the investigation of product labeling and the collection of marketed product samples at the inspecting place. All claims imprinted on the labels of medical device products must have the support evidence kept in a ready-to-be-delivered manner when inquired by the medical device control officer.
FDA is in charge of 6 main responsibilities which are 1) Division Action Plan Making, 2) Division Budget Formulation, 3) Legislative Process Involvement, 4) Medical Device Categorization, 5) Human Resource Development, and 6) Research and Development Involvement.
Action Plan Making
The staff makes an annual action plan in consistence with the National Public Health Policy. Responsibilities includes
- reviews, analyzes, edits, consolidates and justifies the action plan
- tracks and monitors performance of each group in a maner consistent with the FDA intent and the division action plan, and
- analyzes and presents annual division performance to the FDA.