Medical Device Administration In China

2,589 views

Published on

Sept.18, 2006
Excel PharmaStudies Inc.

Published in: Economy & Finance, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
2,589
On SlideShare
0
From Embeds
0
Number of Embeds
25
Actions
Shares
0
Downloads
77
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Medical Device Administration In China

  1. 1. Medical Device Administration in China Sept.18, 2006 Excel PharmaStudies Inc.
  2. 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. 3. Administration Scope of SFDA Administration activities by the SFDA: 1, Medical device registration, 2,Production, 3,Sales, and 4,Post-marketing surveillance
  4. 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. 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. 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. 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. 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. 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. 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 ? ?
  11. 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. 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. 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

×