After a medical device manufacturer finds a distributor in China market, the manufacturer must register the product to SFDA so that the product can enter Chinese market legally.
The manufacturer shall authorize a registration agent in China to handle all the registration processes, and nominate after-sales service party before hand. The after sales service agent can be the same as the authorized distributor (please go to our featured article 'How to find distributors in China'), or can be a third party. The manufacturer shall also issue 'Letter of Guarantee to Authenticity' to guarantee the authenticity of the documents provided to SFDA through the registration agent.
Then the manufacturer and the registration agent can work on legal documents requested by SFDA.
The application form should also be filled in and submitted together with the requested documents.
The whole registration process may cost some time, which may also involve establishment of standards and testing depending on the classification of the devices to be registered.
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