China CFDA Registration process

Qserve can help you obtain regulatory approval for your medical device or In Vitro Diagnostics (IVD) in China. Our experts work directly with the China Health Authority, coordinating the submission of regulatory files and answering the Health Authorities feedback.

In China, medical devices are divided into three risk level categories: class I, class II and class III. For the higher risk classifications, there is again a division in requirements. For this reason, it is important to have confirmation of the classification before starting the registration process.

"China is a challenging market, but our China team has the regulatory knowledge to help you succeed"
Stephanie Huang, General Manager China

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China services

Overseas inspection

China regulations changed rapidly in the last 3 years and the impacts are now to be seen. The impact on the inspection regulation has resulted in last year that China Health Authority has performed X overseas inspections. These are audits comparable to MDSAP or Notified Bodies. It is an additional burden for the manufacturer with potentially high risks if you are stopped selling to China. Preparations for these audits are becoming increasingly important. Mock-audits to prepare the organization for the China Health Authority inspection teams are a successful tool.

 

China Agent

The regulations on China Agents recently changed where the requirements but foremost the liabilities and responsibilities are increased. One of the new requirements is that ‘Full dossier could be available at China Agent’. This is a relatively easy requirement however with a major impact on your IP. Do you want all your technical details readily available at your China agent who is in most cases also your distributor? The safe haven is to separate China Agent services from distributor services. Qserve is qualified independent China Agent. More information


Clinical Situation China

For the registration file in China one of the required documents is Clinical Evaluations. Although you should have this document for your EU and US registrations, the requirements in China are slightly different. China positions the clinical safety in between the requirements of EU (Notified Bodies) and US (FDA). The new acceptance criteria on clinical data are published since early 2018, while the new requirement on clinical evaluation is to be released in 2019.

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