Product Registration The requirements for registration of imported medical devices in Thailand de

Product Registration

The requirements for registration of imported medical devices in Thailand depend on the classification of the device. For example, to sell Class III medical devices in Thailand, the Thai FDA requires a local entity, a general import license, and a product specific import license.

A local entity with its business registered with the Thai government can be a foreign device manufacturer’s subsidiary, a distributor, or an independent third party.

The general import license is a government issued license that allows a local entity to import all kinds of general medical devices into Thailand. Many companies, consultants and distributors in Thailand already have a general import license, so foreign medical device companies (those without an office in Thailand) most likely will not have to obtain this license themselves.

The product-specific import license allows an importer to bring a specific product into Thailand. For applications to the product-specific import license, the Thai FDA requires documents such as the

Certificate of Free Sale, a company’s commercial registration, a Certificate ofIncorporation or Partnership stating the company’s objectives, etc. Implanted Class III medical devices also will need to include a GMP (good manufacturing practices) certificate or an ISO 13485 certification in their product-specific import license application.

A Certificate of Free Sale/Certificate to Foreign Governments submitted to the Thai FDA for the product specific import license should indicate the product is allowed to be sold in the manufacturing country, include the name of the manufacturer, and list the name of the medical device with information such as its model, type or product code.

If all the documents discussed above can be submitted in perfect condition, the product-specific import license can be received in only one day. However, the Thai FDA often will place a request for missing or supplementary documents if it finds that required documents are faulty or not included in the application.Thus, it normally takes the Thai FDA approximately three to five months to issue the product-specific import license.

Once a manufacturer or the legal agent has obtained the product-specific import license from the Thai FDA, the department will notify the Thai Customs Department to permit clearance of the Class III “General” medical device when it arrives in Thailand.