Product Registration

In order for a medical device to be legally sold in China, it must receive approval from China’s regulatory body, the SFDA (State Food and Drug Administration).   Depending on the class of product as defined by the SFDA, the requirements and timelines can vary considerably.

Contrary to what many others might claim, there is no “fast track” to approval in China anymore and “special” relationships will not expedite the process.  The process has become much more methodical and transparent.  However, problems in communication and/or lack of understanding in the process can cause significant delays and costs.

Medical Technology in ORThrough our team’s successful management of over 50 product registrations in China, as well as other projects directly involving the SFDA, we have gained deep understanding of the registration process as well strategies on effective communication with the SFDA.

Due to our holistic approach, our business goals are directly aligned with the manufacturer to obtain the approval as expediently as possible.  In the case where a local clinical trial is required, we help companies develop clinical protocols for the best clinical and market outcomes.

Based on the product and a number of other factors, we work with the manufacturer to choose the appropriate strategy for product approval and set the appropriate timeline expectations.    We professionally manage the entire process to avoid delay and ensure the product is approved as quickly as possible.