Procedure Definition of Medical Devices

Procedure Definition of Medical Devices 1. Definition of Medical Devices Medical devices are equipment, products or articles required in medical usage...

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Procedure Definition of Medical Devices 1. Definition of Medical Devices Medical devices are equipment, products or articles required in medical usage, by clinical practitioners of medicine, in the diagnosis of diseases such equipment includes syringes, ultrasonic therapy products, X-ray scanners, blood pressure measurement equipment etc. There are also various kinds of medical devices that we use in daily life, such as absorbent cotton wool, eye glasses, adhesive plaster, condoms etc. At present, medical devices vary in kind and are more user friendly since medical technology has experienced substantial improvement in recent years. Consumers can buy and use medical device without doctors’ supervision. Medical devices are also widely used for beauty enhancement purposes. This brings problem of improper use of medical devices, harming the user, develops high competition in business, advertising without permission or false and/or deceptive adverting. Section 3 of the Medical Device Act (B.E. 2531) (which is now the fundamental law in protecting consumers of medical devices) defines the meaning of medical devices as follow: (1)Equipment, products or articles used in the medical profession; the profession of nursing and midwifery, of the clinical practice of medicine or of veterinary as prescribed by the legislation concerned; (2)Equipment, products or articles that have effects on the health, the structure or any functions of human or animal body; (3)Constituents, components, accessories or parts of the equipment, product or articles under (1) or (2);

(4)Other equipment, products or articles prescribed by the Minister as medical devices as published in the Government Gazette.

2. Control of Medical Devices Medical device in Thailand are classified into 3 groups according to the level of stringency of the law as follow: 1. Licensed Medical devices – this is the most stringently controlled group. There are 6 items in this group, which are 1. Condoms 2. Examination gloves 3. Surgical gloves 4. Hypodermic syringes 5. Insulin syringes 6. HIV test kits for diagnostic use All manufacturers and importers of these 6 items must have a licence issued by the Thai - Food and Drug Administration and must hold quality control accreditation as the Minister of Health requires. For the sixth item, the distributor and the seller must apply for a licence too. 2. Notified Medical devices -. The control of this group is less stringent in comparison to the first group. This group of medical devices composes 1. HIV test kits (for other purposes) 2. Physical therapy products 3. Implanted silicone breast prostheses 4. Alcohol detectors For all these 4 items, manufacturers and importers must notify their medical devices to the Thai - Food and Drug Administration.

And for the first item, the distributor must notify details of the devices too. 3. General Medical devices– This group of medical devices is excluded from group 1 and group 2. But Importers must submit a certificate of free sale which is issued by the Government or authorized private organization in the country of manufacture to get approval by Thai- Food and Drug Administration in order to pass the customs process in accordance with the Notice of The Ministry of Public Health No. 6 (B.E. 2532) on importing prohibited medical device.

Source : Food and Drug Administration Ministry of Public Health