China CFDA Regulatory Approval Process for Medical Devices

Download the Chart on the Medical Device Approval Process in ChinaTo see their products to the Chinese market, medical device and IVD manufacturers will need to obtain China Food and Drug Administration (CFDA) (formerly State Food & Drug Administration or SFDA) approval. Find out more about the CFDA approval process in China by reading or downloading the chart below.

The China (CFDA) medical device approval process explained

The chart shown illustrates the CFDA approval process in China and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

Step 1
Determine classification of your medical device in China using the China Food and Drug Administration (CFDA) Order No. 15 and CFDA's classification database. Class II and III device manufacturers should also identify predicates, as well as determine the clinical data requirements and how to satisfy them.

Step 2
Appoint an Agent located in China who will coordinate your CFDA device registrations.

Step 3
Demonstrate proof of home country approval using a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).

Step 4
Manufacturers must submit a notarized "proof of qualification of the manufacturer." Common ways to satisfy this requirement include: ISO 13485 certificate; Establishment Registration from the FDA for US companies; or Manufacturing License for Japanese or Korean companies.

Step 5
Prepare Technical Requirement document. For Class II and III devices, include details of additional testing to be conducted in China.*

Step 6
For Classes II and III, send devices to China for testing to be carried out by a CFDA authorized laboratory. Pay testing fees.

Step 7
For devices which are classified in Classes II and III and are not on a clinical trial exemption list, prepare China Clinical Evaluation.** Data from clinical trials conducted may be required for many devices.

Step 8
For Class I devices, prepare technical documentation for Class I submission. Submit to CFDA (no submission fees). All documents must be in Simplified Chinese. For Class II and III devices, prepare Registration Dossier. Submit to the CFDA and pay fees. Dossier includes the Technical Requirement document, application for the Import Medical Device Registration Certificate (IMDRC, i.e. registration), notarized proof of qualification of the manufacturer, CFS/CFG, Agent authorization letter, test reports, China Clinical Evaluation (if required), and other documents. All documents must be in Simplified Chinese.

Step 9
Class I submissions undergo an administrative review. Class II and III submissions will have a full application review conducted. This will include a technical and administrative review. Novel and high-risk products may also be subject to an Expert Panel Meeting. CFDA may conduct an onsite QMS audit of manufacturing facilities..

Step 10
Class I devices which pass CFDA review will receive a voucher. Vouchers are published on the CFDA's website and do not expire. For Class II and III devices, CFDA issues IMDRC following successful review. Your IMDRC certificate is valid for 5 years. Place CFDA registration number on your device labeling, including on your IFU/user manual.

Step 11
You are now approved to sell your device in China.

* Foreign test reports are generally accepted for Class I devices; Class II and III devices require a combination of foreign and local test reports.
** The CFDA requires a Clinical Evaluation for all Class II and III devices, unless exempted. The China Clinical Evaluation is unique and significantly more robust than a CER submitted in the EU or US. CER data supplied for these markets will generally not be sufficient for China. Ask us for details.

This is a simplified overview of the process. The CFDA may choose to audit your submission and request more documents, which will add time to your approval.

 

Chart updated: 31/03/2016