Products that make therapeutic, medical or dental claims are considered Medical Devices in Thailand including aesthetic devices and software as a medical device. Medical Devices with a drug component may be registered as a pharmaceutical. Medical devices will be required to undergo one of three registration routes to acquire an Import License depending on their classification.
Class 1 products will require a Listing, Class 2 and 3 will require a Notification and Class 4 highest risk will require a License. Conformity Assessments under the new regulations will require applications for Class products be submitted in the Common Submission Dossier Template CSDT format while Class 1 Listed products require less documentation.
Some products high risk IVDs, gloves, etc. Specific documentation requirements for each application route, as well as transition period exemptions are listed below. This information will be updated as more registrations are issued under the new guidance.
Government Fees are also still under review and may change. Please contact us for latest estimates. Once approved, all types of Registrations Licenses are valid for 5 years.
Before , medical devices were regulates as drugs. In May , the Medical Device Act effective date: 6 March was enforced and the Medical Device Control Division, Food and Drug Administration was officially established in June as regulatory authority to control manufacturing, importing, selling and advertising of medical devices in Thailand.
They include those for animal use, IVD products, software, accessories, components or parts of medical devices and any products announced by the Minister to be medical devices. Pre-Market Approval Control at port by Thai FDA inspectors with close relation with custom officers Advertisement control Post marketing surveillance and vigilance Communication of risk information to the public.
There are three categories of medical devices in Thailand: each with different regulatory requirements. Also it is compulsory to have the Certificate of Free Sale in the Country of origin. Products in this category include syringes, contact lens, surgical gloves and IVDs. However, they do not need to go through the license process. Asia Actual is committed to fair, efficient and transparent importing transactions.
Competitively bid third-party services e. A Shipment Report is generated per event to record fees and document receipts. Basic support from Asia Actual will involve taking title of the shipment through customs clearance and managing the following activities:. Optional support services are available such as long-term storage, break-bulk, labeling, and order fulfillment. Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent importations.
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