China

The Regulatory Process for Medical Devices

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,
and determine the clinical data requirements for their device and how to satisfy them.

Class I Class II Class III

Appoint an Agent located in China who will coordinate your CFDA device registration.

Demonstrate proof of home country approval using documentation such as

a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).

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.

Prepare “Product Technical Requirement” document. Look for applicable Technical Review Guidelines on Chinese Medical Device
Evaluation Center websites. Include details of testing to be conducted in China.* Compile application dossier.

Send devices to China for testing to be carried out by a CFDA authorized Medical
Device Evaluation Center. For devices not on a clinical trial exemption list, prepare
China Clinical Evaluation.** Data from clinical trials may be required.

Prepare technical documentation for

Prepare registration dossier including testing reports, Agent authorization letter,
Class I submission. Submit to CFDA
CFS/CFG, clinical evaluation** (if applicable), and other technical documents.
(no submission fees). All documents
All documents must be in Simplified Chinese then submitted to CFDA for review. Pay fees.
must be in Simplified Chinese.

Full application review conducted, including a technical and administrative review. Novel
Administrative review only. and high-risk products may also be subject to an Expert Panel Meeting.
CFDA has the option to conduct on-site QMS audit of foreign manufacturers.

CFDA issues Class I voucher and Following a successful review, CFDA issues registration certificate
publishes on website. Class I vouchers do and posts online. Certificates are valid for 5 years. You must place your
not expire. You are now approved to sell CFDA license number on your device labeling, including IFU.
5001-0717

your device in China. You are now approved to sell 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 requires comprehensive comparison to an equivalent product already approved
in China, where available. It differs significantly from a CER submitted for European CE Marking. 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.

© 2017 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2017. EmergoGroup.com/china
 China
Time, Cost, and Complexity of Registration

Device classification
Class I Class II Class III
in China

How long you should

expect to wait after
submission until < 1 week 12-20 months* 12-22 months*
approval is granted1

Validity period for

device registrations 2 Does not expire 5 years 5 years

Registration renewal
should be started this Not applicable 18-24 months 18-24 months
far in advance3

Complexity of the Simple Complex Simple Complex Simple Complex

registration process
for this classification4 2 5 5

Low High Low High High

Overall cost of gaining
Low
regulatory approval5 2 5 5

Notes
1. The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue,
medicinal substances or employ entirely novel technology. Devices which are novel in the Chinese market may require an Expert Panel Meeting, which will
add 3-6 months to the review process. The CFDA also reserves the right to audit the manufacturing facility. Your length of approval will depend on the
quality and completeness of your technical documentation and how much time you take to address additional information requests from authorities after
submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.

2. Registrations remain valid for the time specified as long as you do not make changes to the information on the CFDA certificate, its attachment, or the
technical requirement.

3. We recommend starting the re-registration process no later than the time period specified above. However, please consult with your distributor or
regulatory expert well before this suggested time to avoid any lapse in your registration.

4. Prices in US Dollars for a single device. 1 = Less than $5,000; 2 = $10,000 - $15,000; 3 = $15,000 - $30,000; 4 = $30,000 - $50,000; 5 = $50,000 or more.
Estimated cost includes registration application fees, in-country representation, submission preparation consulting, and translation of documents, if
required. Costs assume you already have approval for your device in the United States, Europe, Canada, Australia or Japan. Costs do NOT include product
testing, clinical trials or QMS implementation, if applicable.

5001-0717

* These review times presume the CFDA requests additional information and/or additional testing. Most manufacturers will receive such a requst.
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.

© 2017 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 07/2017. EmergoGroup.com/china