1. The document outlines the regulatory process for medical devices in China, including classification of devices and the approval process for Class I, II, and III devices. 2. Class I devices have the simplest approval process, requiring only an administrative review with no submission fees. Class II and III devices require more extensive technical documentation, testing in China, and clinical evaluations. 3. The approval process can take 12-22 months for Class II and III devices and involves appointing a Chinese agent, submitting documentation and application materials in Chinese, testing, and a review by the China Food and Drug Administration before a registration certificate is issued.

1. China
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 12/2016. EmergoGroup.com/china
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.
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.
Prepare technical documentation for
Class I submission. Submit to CFDA
(no submission fees). All documents
must be in Simplified Chinese.
Administrative review only.
CFDA issues Class I voucher and
publishes on website. Class I vouchers do
not expire. You are now approved to sell
your device in China.
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 registration dossier including testing reports, Agent authorization letter,
CFS/CFG, clinical evaluation** (if applicable), and other technical documents.
All documents must be in Simplified Chinese then submitted to CFDA for review. Pay fees.
Full application review conducted, including a technical and administrative review. Novel
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.
Following a successful review, CFDA issues registration certificate
and posts online. Certificates are valid for 5 years. You must place your
CFDA license number on your device labeling, including IFU.
You are now approved to sell in China.
Class I Class II Class III
5001-1216
The Regulatory Process for Medical Devices
* 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.

2. China
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.
EmergoGroup.com/china
Device classification
in China
Class I Class II Class III
How long you should
expect to wait after
submission until
approval is granted1
< 1 week 12-20 months* 12-22 months*
Validity period for
device registrations 2 Does not expire 5 years 5 years
Registration renewal
should be started this
far in advance3
Not applicable 18-24 months 18-24 months
Complexity of the
registration process
for this classification4
Overall cost of gaining
regulatory approval5
5001-1216
Low High
Simple Complex
Low High
Simple Complex
Low
High
Simple Complex
© 2016 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 12/2016.
Time, Cost, and Complexity of Registration
* 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.
5 5
5 5
2
2