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2013

China To Streamline Re-Registration Medical Device Regulations

Published:2013-05-13

Re-registration of a medical device in the Chinese market should become easier in the near future, thanks to efforts being made by the China Food and Drug Administration to simplify the current re-registration process. Currently, medical device manufacturers must re-register within six months of the expiration of a product’s original registration certificate. The move is expected to significantly reduce the number of product reviews and amount of documentation required for each re-registration submission.

Under the current system, a re-registration requires the submission of a substantial amount of documentation, much of which duplicates information that was provided during the initial approval process. In order to reduce the burden on medical device companies seeking to re-register, the new draft proposal from the CFDA does not require the submission of technical information if there have been no changes which impact the safety or efficacy of the product in question.

Furthermore, if changes have been made to a medical device, only technical documentation related to those specific alterations is required to be submitted, along with a device vigilance report addressing adverse events associated with the product. Major changes, however, would require that the medical device be treated as a new product, which would in turn force it to go through a new product registration.

One of the primary motivations behind the streamlining of its medical device re-registration process is the desire by China to improve the speed at which innovative products reach the market. The CFDA is in the midst of pondering the establishment of a dedicated office that would exclusively handle innovative medical device submissions, with an eye towards creating a ‘fast-track’ approval channel for products which meet very specific requirements. In order to be eligible for this program the CFDA would require that a medical device make its global debut in China, be registered in China under an invention patent, demonstrate a ‘significant improvement’ over similar medical devices, and offer a full research and development history establishing its pioneering status in its field.

@AptivSolution