This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.

1. Medical Device Administration in China
Sept.18, 2006
Excel PharmaStudies Inc.

2. Competent/Administrative Authority
Competent authorities concerned:
1, SFDA
2, Center for Medical Device Evaluation
3, Testing Authorities designated by the SFDA
4, SFDA’s affiliates

3. Administration Scope of SFDA
Administration activities by the SFDA:
1, Medical device registration,
2,Production,
3,Sales, and
4,Post-marketing surveillance

4. Legislation
Laws, regulations and provisions in medical device:
1, Regulations for Supervision and Administration of Medical
Device
2, Provisions for Supervision and Administration of Medical
Device Production
3, Provisions for Administration of License for Medical Device
Dealer
4, Provisions for Administration of Medical Device Registration
5, Provisions for Clinical Trial of Medical Device
6, Provisions for Administration of leaflet/insert sheet, Labeling
for Medical Device
7, Provisions for Administration of Medical Device
Specifications/Standards
8, Provisions for Medical Device Classification

5. Classification of Medical Device
For the purpose of medical device administration,
medical device can be divided in three categories as below:
Class I medical device, it is with low risk and considered as safety
and also only requires general control
Class II medical device, it has middle risk with relative safety and
needs special control
Class III medical device, this kind of device is with high risk and
requests highly special control
Note: Different categories of medical devices have different
registration requirements and administrative treatment

6. Administration of Production of Medical Device
Medical device manufacturer must be with the followings:
Medical Device Production Permit issued by SFDA’s provincial affiliates
Business License issued by Bureau of Business
License for Each Medical Device issued by the SFDA or its affilicates
Certificate for Quality Management System
Note: Medical Device Production Permit is valid for 5
years and should be renewed at the time of expiry date

7. Administration of sales of Medical Device
In China, Medical Device dealer must be with the followings:
License for Medical Device Dealer issued by SFDA or its
affiliates
Business License issued by Bureau of Business
Note:
1,The License for Medical Device Dealer is valid for 5 years and
should be renewed at the time of expiry date.
2, In the near future, the SFDA will enforce the Good
Distribution Practice for Medical Device distribution

8. Administration of Medical Device Registration
-General
All medical devices must get pre-market approval
called medical device license in China from
the SFDA or its affiliates for the purpose of market in
China
Medical Device License will be valid for 4 years and
should be renewed six months before expiry date

9. Administration of Medical Device Registration
-timeline
Class I: 85 workdays
Class II: 120 workdays plus time window of clinical trial
Class III: 150 workdays plus time window of clinical trial

10. Administration of Medical Device Registration
-Cost for Import Medical Device
Application cost
Testing fee charged by testing Application fee charged by
authority the SFDA
USD362-3,620 USD362
Excel’s professional service fee for Regulatory
Affairs: USD5,000-25,000
Clinical Trial cost
Excel’s service fee Investigator fee
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11. Administration of Medical Device Registration
-Procedure
Step I: based on product standard/specifications provided by sponsor
Excel Compile product specifications in accordance with the
requirements and format of SFDA
Step II: Get verification and approval on the product
standard/specifications from testing authority
Step III: provide sample to testing authority for testing and get the testing
report
Step IV: Conduct clinical trial if required and get clinical trial report
Step V: compile all the application dossier and submit the SFDA for
review
Step VI: SFDA internally go the review procedure and issue the medical
device license

12. Administration of Medical Device Registration
-Dossier Requirements for Import Medical Device
Application form
Qualification certificate of medical device manufacturer
Letter of authorization to applicant agent
PMA or 510K
Product Specifications following Chinese format and requirements
Use instruction or insert sheet
Testing report issued by testing authorities qualified by the SFDA
Clinical trial report
Guarantee letter for the quality of product
Letter of Authorization for sales agency in China and letter of promise and
business license
Letter of authorization for designated after-sales services agency in
China and letter of promise and business license of the authorized
agency
Self-declaration by the enterprise to guarantee the truthfulness of the
documentation submitted

13. Excel’s Contribution
Translation
Compile product standard/specifications
following Chinese format and requirements
Handling affairs associated with testing
Prepare and submit application dossier
Follow up and monitor review progress
Deal with problems occurring during review
Get license