Thailand medical device registration
Southeast Asia product certification introduction
In order to handle imported medical devices in Thailand, business registration, medical device import license (Thai FDA), and certification procedures according to the classification of medical devices are required.
The conformity assessment of medical devices is regulated by the Medical Device Act 2008 and is under the jurisdiction of the Food and Drug Administration (FDA) under the Ministry of Public Health.
Regarding product certification, the Thai Food and Drug Administration categorizes medical devices into three categories: General Medical Device, Notified Medical Device, and Licensed Medical Device. Is 5 years, and an extension is required after 5 years.
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1. General Medical Devices Certification_Class l
Producers, importers, or distributors of products in this category do not need to obtain a separate license. However, they are required to submit a Certificate of Free Sale issued by the government of the country of origin. As an exception, for the following medical devices that are used directly on the human body among general medical devices, ISO 13485 or GMP certificates must be submitted.
✡ Tissue origin medical device
✡ Radiation equipment for diagnosis and treatment In vitro diagnostic equipment (In Vitro Diagnostic Products)
✡ Medical equipment disinfection supplies
✡ Tooth filling, prosthetic-related devices
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2. Notified Medical Devices Certification_Class ll
In addition to the certificate of free sale issued by the government of the country in which the product is produced, producers, importers or distributors of products falling under this category must submit product technical documentation together with a declaration form (Jor Nor 1), which must include:
✪ Product technical documentation: product instructions, instructions, specifications, labels, names of producers and distributors
✪ Target medical device
⁖ Rehabilitation treatment medical equipment
⁖ Blood alcohol diagnostic tool
⁖ Medical silicone
⁖ Other diagnostic tools
⁖ Silicone breast implants
⁖ Ophthalmic Viscosurgical Devices; OVD
⁖ Metamphetamine screening test in urine
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3. Licensed Medical Device Class III
Producers, importers, or distributors of products falling under this category must obtain a license to produce, import and sell products. The Thai Food and Drug Administration requires the licensee to submit information on the production process, import, sale, and side effects of the product. Also, the Thai Food and Drug Administration requires a Certificate of Free Sale and an application for permission (Khor Por 1) issued by the government of the product producing country. ) Must be submitted.
There are 8 types of medical devices in this category:
⁖ HIV diagnostic tool
⁖ Lab gloves
⁖ surgical gloves
⁖ Medical blood bag
⁖ Contact lens
⁖ Disposable hypodermic syringe
⁖ Disposable insulin syringe
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Related Services from IGC
01System Certification (ISO 13485, ISO 15378, ISO 14155)
02Product certification (European CE certification, clinical evaluation, medical device registration [Eurasia, China, USA, Thailand, Taiwan])
03Certification of screening qualifications
04Professional manpower training education