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The Regulatory Approval Process for Medical Devices in China

Register your medical device with China’s Food and Drug Administration

The medical device market in China is one of the largest markets for medical devices in the world, making it an important strategic target market for medical devices manufacturers worldwide.

All medical devices marketed or sold for use in China must be registered with China’s Food and Drug Administration (CFDA, formerly known as the State Food and Drug Administration, or SFDA). While there are many similarities with registration requirements in the U.S. and the European Union, the classification of medical devices China follows the requirements of SFDA Order No. 15, and includes some important deviations from classification schemes in other countries.

The CFDA classifies Medical Devices into three categories according to their respective risk potential:

  • Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration.
  • Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness.
  • Class III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risks to the human body, and thus must be strictly controlled with respect to safety and effectiveness.

For importers, the registration process requires the submission of a registration standard along with device samples for testing. Manufacturers of Class II and Class III medical devices are also required to demonstrate that the device has been approved by the country of origin with documents like a CE certificate, 510(k) letter and PMA approval and compliance with ISO 13485, and may also be required to submit clinical data in support of their application. In addition to these requirements, all medical device manufacturers must also include product information in Chinese on all packaging and labelling, as detailed in SFDA Order No. 10. The term of validity for the registration certificate for Medical Devices is four years/five years for IVDD. The holder of the certificate shall apply for re-registration within six months before the certificate expires. The CFDA shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application.

Finally, manufacturers exporting medical devices to China must appoint several China-based agents to act on their behalf. These include a registration agent to coordinate the CFDA registration process, a legal agent to handle any adverse events reported with a registered device, including a product recall, and an after sales agent to provide technical service and maintenance support.

Why TÜV SÜD

TÜV SÜD has awarded CARAT (Certified after Recognition of Agent’s Testing) recognition status to the four largest medical test laboratories in China. These test laboratories recognise the results of prior testing conducted by TÜV SÜD Product Service, potentially expediting the registration process in China. TÜV SÜD Product Service also has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own clinical affairs department, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres

Services At a Glance

Direct access to medical test laboratories in China - TÜV SÜD Product Service has established effective working partnerships with the leading medical device test laboratories in China, which recognise the results of prior TÜV SÜD Product Service testing. These partnerships can expedite the registration process for imported medical devices. TÜV SÜD Product Service can also assist in the evaluation and direct submission of registration applications to the CFDA.

One stop shop solution - TÜV SÜD Product Service is able to offer a package of services including a tailored registration plan, regular updates and feedback, guidance on documents with samples, document pre-review, proactive liaison with CFDA, the drafting of technical documents, 360° arrangements for tests and the interpretation of technical documents.

Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.

Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.

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