China’s SFDA Cleans Up Medical Device Registration Requirements

In September 2008, China’s State Food and Drug Administration (SFDA) issued a notice that continues standardization of the registration process for imported medical devices.

Several previous notices were abolished and thus no longer apply. Medical device companies applying for product registration should make sure to stay up-to-date with current regulations. Abolished notices include the following:

  • Regarding regulating clinical trials for imported medical devices (1997, No. 280)
    This notice specified the requirements for clinical trials, including the persons conducting the clinical trials, the scope or size of the clinical trials, the clinical trials process, the clinical trials report, and circumstances for permissible exemptions.
  • Regarding the testing requirements for registration of imported medical devices (2001, No.130)
    This notice specified the requirements for the testing of imported medical devices that have market approval from their country of origin. Specifications include requirements for the testing agency, testing standards, the testing process (including cost, duration, and amount of product tested), the test report, and an appeals process.
  • Regarding the additional instructions for imported category III medical devices (2001, No. 478)
    This notice specified additional instructions for registering imported category III medical devices, including requirements for supporting documentation, reapplication process upon expiration of the application period, notification upon change in the technology of the product, clinical trials, name registration and changes, and import testing.
  • Regarding additional requirements for registration of imported medical devices (1) (2002, No. 259), and (2) (2003, No. 119)
    These notices specified additional requirements for registering imported medical devices, including requirements for registration of manufacturing relocation or change in process, registration of products with components manufactured in multiple countries, product classification, disposable products, products from Hong Kong or Taiwan, manufacturer’s approval form, and the product registration form.

Also, in accordance with domestic regulations, the notice clarifies that the following medical devices may delay additional testing until after import registration:

  • X-ray computerized tomography scanner (CT), positron emission tomography scanner (PET), single photon emission computed tomography scanner (SPECT), extracorporeal shock wave lithotripsy (ESWL), large-scale color ultrasound diagnostic equipment, large laser treatment equipment, large-scale X-ray diagnostic equipment, large-scale automatic biochemical analyzer, cobalt 60 therapy, Gamma Knife, the medical linear accelerator, simulation, and medical magnetic resonance imaging systems (MRI).