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China Regulatory Process and Approval Timeline

The document outlines China's medical device regulatory approval process. It discusses classifying devices, appointing legal and after sales agents in China, demonstrating proof of approval in the home country, submitting devices for testing to an authorized laboratory, potential clinical trials requirements, preparing and submitting a registration dossier for approval, and obtaining an import medical device registration certificate to sell devices in China. Approval times typically range from 19-24 months for Class I devices, 25-30 months for Class II, and 31-36 months or more for Class III.

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540 views2 pages

China Regulatory Process and Approval Timeline

The document outlines China's medical device regulatory approval process. It discusses classifying devices, appointing legal and after sales agents in China, demonstrating proof of approval in the home country, submitting devices for testing to an authorized laboratory, potential clinical trials requirements, preparing and submitting a registration dossier for approval, and obtaining an import medical device registration certificate to sell devices in China. Approval times typically range from 19-24 months for Class I devices, 25-30 months for Class II, and 31-36 months or more for Class III.

Uploaded by

psp710
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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CHINA

Class I

The medical device regulatory approval process

Determine classification of your medical device in China using the China Food and Drug Administration (CFDA) Order No. 15 and other CFDA documents.

Class II

Class III

Appoint a Legal Agent and After Sales Agent located in China who will coordinate and control your CFDA device registration.

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

Foreign manufacturers must submit a notarized quality system certificate such as ISO 13485 or proof of US FDA QSR compliance.

Submit your device to the CFDA for testing. Testing is carried out by a CFDA authorized laboratory.

Clinical trials conducted in China may be required for some devices, including high-risk and implantable devices.

Prepare Chinese Registration Standard dossier, including testing results, and submit to CFDA for approval.

Prepare application for an Import Medical Device Registration Certificate (IMDRC) and submit to CFDA for approval. Class II and III submissions will also include the Registration Standard dossier.

CFDA issues IMDRC following application review. Your IMDRC certificate is valid for 4 years. Place CFDA registration number on your device label, packaging material and user manual. You are now approved to sell your device in China.

5001-1113

2013 Emergo Group You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 11/2013.

Learn more about China:

EmergoGroup.com/china
2013 Emergo Group Inc. All Rights Reserved

19-24 months

25-30 months

31-36 months

  Average time from submission of required registration documents until approval is officially granted by the CFDA.

CLASS I CLASS II CLASS III


= Period during which approval may occur.

NOTE: The time frames shown above are typical for the majority of medical device submissions prepared by Emergo Group but assume that your device does not contain animal tissue or medicinal substances. However, review times DO assume that your device already has home country approval outside China. Your length of approval will depend on the quality and completeness of technical documentation used in the submission, time needed for product testing, additional requirements/questions from Chinas State Food and Drug Administration (CFDA) after submission, and how much time you take to address additional information requests. Also, while many Ministries of Health publish goals for registration review time frames, those should generally be viewed as best case scenarios and often reflect working days, not calendar days. YOUR SUBMISSION(S) MAY TAKE MORE THAN WHAT IS SHOWN ABOVE. 2013 Emergo Group You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 11/2013.

Learn more about China:

EmergoGroup.com/china
2013 Emergo Group Inc.

36+ months

10 months

11 months

12 months

13 months

14 months

15 months

16 months

17 months

18 months

CHINA
1 month

Typical approval time frames for medical devices

2 months

3 months

4 months

5 months

6 months

7 months

8 months

9 months

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