China

The Regulatory Process for Medical Devices

Determine classification of your medical device in China using the National Medical Products Administration (NMPA) Order No. 15 and
NMPA’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 NMPA 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 an NMPA-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 Class I

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

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

NMPA issues Class I voucher and Following a successful review, NMPA issues registration certificate
publishes on website. Class I vouchers do and posts online. Certificates are valid for five (5) years. You must place your NMPA license
not expire. You are now approved to sell number on your device labeling, including IFU.
your device in China. You are now approved to sell in China.
5001-0119

* 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 NMPA 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 NMPA may choose to audit your submission and request more documents, which will add time to your approval.

© 2019 Emergo by UL - Have comments or suggestions about the content of this chart? Email us at EmergoMarketing@ul.com. Table updated 01/2019. EMERGObyUL.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 granted.1

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 advance.3

Complexity of the Simple Complex Simple Complex Simple Complex

registration process
for this classification. 2 5 5

Simple Complex Simple Complex Simple Complex

Overall cost of gaining
regulatory approval.4 2 5 5

Notes
1. The time frames shown above are typical for the majority of medical device submissions but assume your device does not contain animal tissue, medicinal
substances or employ entirely novel technology. Devices that are novel in the Chinese market may require an Expert Panel Meeting, which will add 3-6
months to the review process. The NMPA 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 NMPA 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.

5001-0119

* These review times presume the NMPA requests additional information and/or additional testing. Most manufacturers will receive such a request.
This is a simplified overview of the process. The NMPA may choose to audit your submission and request more documents, which will add time to your approval.

© 2019 Emergo by UL - Have comments or suggestions about the content of this chart? Email us at EmergoMarketing@ul.com. Table updated 01/2019. EMERGObyUL.com/China