Verification Process for Certificate of Free Sale of the General Medical Device
- 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.
Steps to be taken
- 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.
(1) A “medical device” shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article :
(a) intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific purpose(s) of :-
- used by medical health processions for human or animals
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury
- investigation, replacement, modification, or support of the anatomy or of a physiological process.
- supporting or sustaining life,
- aids for disabled / handicapped of human beings and animals
- providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human or animal body
- disinfection of medical devices
- (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
(2) apparatus or spare part of instrument, machine or products as (1)
(3) apparatus, machine, products or other thing which is specified as medical devices by the ministry of Public Health.
- Cover only importing General Medical Device which are not the following medical devices
- Examination Gloves
- Surgical Gloves
- Sterile Disposable Syringes
- Sterile Disposable Insulin Syringes
- HIV Test Kits
- Contact Lens
- Physical Therapy Products
- Alcohol Detectors
- Silicone Breast Prostheses Implant
- Equipment or instrument topical used for breast enhancer
- Importer might be a private individual, person, government agency or public enterprise and willing to import the medical device progressively not temporarily
- The importers of medical devices for human use which might be at risk or any consumer reasons’ risk as the following items :
- Implant products
- Devices which derived from tissues or tissue by – product
- Sterile products
- Radiological instruments both for diagnosis and therapy (5) Invitro-Diagnostic products for
- Blood Group test : ABO system, Rhesus (C,c,D,E,e) anti-kell
- Diagnostic Agents for Diagnostic Agents for : HIV infection (HIV I and II), Hepatitis infection (A,B,C, and D), HTLV infection (HTLV I and II), Antihumanglobolin (Coombs’ reagent), Anti-CMV (Cytomegalovirus), HPV,HLA typing, Biochemical test : Glucose, lipid profile,liver function test, Uric acid,BUN, Creatinine, Pregnancy test, Drug abuse, Hormones (Thyroid,Fertile), Tumor markers (AFP,CEA and PSA) and Cardiac markers (CK, CK-MB and Troponin)
- Disinfectant Solution for medical device.
- Restorative Material and Orthodontic Products
They must prepare the Certificate of Free Sale and / or the Certificate of Quality System for manufactures(s) as indicated in the Food and Drug Administration Guidance.
Regulation and Guidance :
- Medical Device Act (2008) 2551 B.E. / Medical Device Act 2531 B.E.
- Public Health Announcement (No.34) 2549 B.E. on Medical Device Prohibited in Import or Sale (under Medical Device Act 2531 BE)
- Food and Drug Administration Ordinance 2550 B.E. on Guidance of the Certificate Document using for Importation and Guidance for the exemption at the Thai-FDA Custom office, Important Export Inspection Division (under Medical Device Act 2531 B.E.)
- One item : 1 working day
- Not more than 100 items : 4 working days
- More than 100 items : 5 working days
4. Forms to be Filled
- Certificate of Free Sale Check Form
- Detail of CFS Form
-None- (It will be changed in this near future)
Section 82 Any person who violates the announcement in section 6 (11) shall be liable for imprisonment not over five years or fined not over five hundred thousand baht or both.
7. Contact Address
General Medical Device Section, Medical Device Control Division, Food & Drug Administration of Thailand Ministry of Public Health, Royal Thai Government Tiwanont Road Tambon Talatkhwan Amphur Muang, Nonthaburi , Tel: 0-2590-7243, 0-2590-7248 Fax. 0-2591-8480 Email : firstname.lastname@example.org