On July 23, 2008, the State Food and Drug Administration (SFDA) issued the Interim Provisions for Further Strengthening and Standardizing the Registration of Medical Devices which went into effect on the same day.
Under the Interim Provisions, when applying for medical device registration, a manufacturer must submit electronic copies of the medical device’s specifications and instructions in addition to hard copies. This applies to initial registrations, re-registrations, and the alteration of specifications and instructions.
The Interim Provisions provide that, after examining the application materials, the department of technical evaluation should send the manufacturer a one-time notice requesting all the supplementary documents it deems necessary. The manufacturer must, within 60 working days, submit all the requested documents at once. For Class III (high risk devices regulated by the SFDA as opposed to the provincial governments) and imported devices, the department of technical evaluation must complete its technical examination of the device within 45 working days from the date it receives the supplementary documents from the manufacturer.
If the government issues any national standards or industry standards that apply to a medical device that has already been registered, then the manufacturer may, within six months prior to the expiration date of its medical device registration certificate, apply for re-registration. If the standards issued are mandatory, then the manufacturer must conform to them immediately. When it announces the issuance of new standards, the SFDA will state whether re-registration is required for safety reasons.
If the SFDA reclassifies already-registered medical devises to a lower class, which means that the government will ease its scrutiny on the devices, then the medical device registration certificates will remain valid until their original expiration date. However, if a device is reclassified to a higher class, which calls for stricter scrutiny, the manufacturer must apply for a modification to the original registration certificate and re-register the device.
A foreign medical device manufacturer that does not have an office in China must appoint a legal entity to act as its agent. A foreign manufacturer’s offices or agent in China must act as a liaison between the drug administration and the foreign manufacturer, reporting adverse incidents and recalling medical devices with potential safety problems. In addition, the manufacturer and the agent are jointly responsible for the quality guarantee of and after-sale services for imported medical devices.