Initial Registration of Imported Medical Devices in China

The regulatory authority that oversees the medical devices in China is the State Food and Drug Administration (SFDA).

To introduce the main steps of an initial introduction of products to the Chinese market, one shall apply the official regulations, such as:

• Regulations for the Supervision and Administration of Medical Devices<.li>
• Initial Registration of Imported Products (Medical Devices) - see Device Registration in Europe (Italy, Portugal, Greece, France & Latvia) for equivalent references;

Regarding the first imports of foreign medical devices and their registration on the Chinese market, Article 11 of the Regulations for the Supervision and Administration of Medical Devices states:

“When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issued by the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.”

Therefore, to be able to sell in China one needs to acquire the so-called Import Medical Device Registration Certificate (IMDRC). This certificate can be obtained through submitting product information together with Chinese Registration Standard document and samples submitted for testing. Producers of IVDs and higher risk devices might be asked to provide data from clinical trials performed in China.

Here, it has to be highlighted that for the following Medical Devices, it is necessary to carry out after-registration testing as well:

1. X-Ray Computerized Topography (C T)
2. Positron Emission Computerized Topography (PET)
3. Single Photon Emission Computerized Topography (SPECT)
4. Extraneous Shock Wave Crusher
5. Color Ultrasonic Diagnostic Scanner
6. Large Laser Therapy Apparatus
7. Large X-Ray Diagnostic Equipment
8. Automatic Biochemical Analyzer
9. Cobalt 60 Therapy Unit
10. Gamma Knife
11. Medico-electronic Linear Accelerator
12. Simulated Positioner
13. Magnetic Resonance Imaging System

Moreover, companies must appoint a Legal Agent (LA) and an After Sales Agent. The Regulation in China allows the distributor to fulfill the role of the Legal Agent but it prevents the manufacturer from subsequent switching of distributors since the appointed LA controls the company’s device approval. Hiring an independent LA provides more control over distribution.

AccuService, Obelis’ international office for China, can help you with the entire process of registration of your Medical Devices and support you in placing your products on the market.

For more information on Chinese regulation or to contact Obelis International Office in China, please visit our Obelis International Offices (O.I.O.) page.

Last updated Mar 12, 2012

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