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China: Medical Device Regulations

This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.

For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.

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China: Medical Device Regulations

  1. 1. China: Medical Device Regulations Pacific Bridge Medical 2013 White Paper www.pacificbridgemedical.com
  2. 2. China: Medical Device Regulations Pacific Bridge Medical 2013 White Paper Copyright © 2013 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.
  3. 3. Map of China Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 3
  4. 4. Medical Device Market ❖ China is the 7th largest medical device market in the world – soon to be the 4th largest ♦ It is valued at approximately USD $9.0 billion for 2011 Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 4
  5. 5. China: Medical Device Regulatory Authorities ❖ State Food & Drug Administration (SFDA) ♦ Founded in 1998. ♦ Equivalent to the U.S. FDA. ♦ Responsible for medical devices, drugs, and healthcare services. ♦ Headquarters is located in Beijing, with offices in each province also. ❖ General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) ♦ Conducts mandatory safety registration, certification, and inspection for certain devices. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 5
  6. 6. SFDA: Medical Device Department Department of Medical Device Supervision Division of General Affairs Direct Affiliation Division I of Registration Division II of Registration Division of Manufacturing & Distribution Supervision Division of Research & Reevaluation Center of Medical Device Evaluation (CMDE) Division of Medical Device Provincial FDA Indirect Affiliation Certified Test Centers in Key Provinces Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 6
  7. 7. Legal Agent ❖ Must be a registered entity in China ❖ Must provide the following services: ♦ Report adverse events in China to SFDA according to China’s regulations ♦ Act as the coordinator between the foreign company and the SFDA • This also requires reporting of adverse events that occur outside of China to SFDA according to China’s regulations ❖ Handle any recall issues in China (if any) Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 7
  8. 8. After Sales Agent ❖ Must be a registered entity in China ❖ Party that provides technical support after product is registered ❖ Business license must include this statement: ♦ “provides technical service and support for device products” Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 8
  9. 9. Registration Agent ❖ Must be a registered entity in China ❖ Submits registration/re-registration documents to SFDA ❖ Key individual/organization that SFDA will contact throughout registration process. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 9
  10. 10. Medical Device Classification ❖ Device Classification is the basis for determining regulatory requirements: ♦ Class I – Those which safety and effectiveness can be ensured through routine administration. ♦ Class II – Those which further control is required to ensure their safety and effectiveness. ♦ Class III – Those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 10
  11. 11. Official Medical Device Classification ❖ For innovative products and combination products, getting an official SFDA classification can be very helpful. ♦ Trying to go through product registration with certain products without an official classification can sometimes cause delays, more troubles. The SFDA would issue an official written classification that it CANNOT take back. ❖ The process can take from 3 to 6 months, but the SFDA in general has been very slow in this regard. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 11
  12. 12. China Product Registration: Key Points ❖ Third Party Review not allowed; need approval from the SFDA. ❖ Some classifications are different from the U.S. ❖ Class 1 Medical Devices also need SFDA approval. ❖ Need to submit Chinese Specification for SFDA review and approval. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 12
  13. 13. New Class II products that do NOT require clinical trials Product Registration Process Normal Timeline 1. Chinese Specification Drafting Dossier Preparation & Specification Drafting Depends on the Company and Product 4 - 5 Months Sample Testing 5 working days Filing to SFDA 3 months 3 - 5 months 2. Sample Testing 3. SFDA preliminary review & issues acceptance notice 4. CMDE review No 5. SFDA final approval CMDE Review Yes Approximate Total 10 - 13 months Copyright © 2013 Pacific Bridge Medical SFDA Final Approval | www.pacificbridgemedical.com 13
  14. 14. Product Standard ❖ The Product Standard is the most important part of the registration: ♦ Because the product standard is not reviewed by the CMDE before testing, sample testing is done on the company’s product standard. ♦ If the testing result is deemed unsatisfactory, the CMDE/SFDA may request the company to revise the product standard and re-test. ♦ Also, the SFDA will refer to the product standard to determine if different models can be registered under one import device license. ❖ Therefore, make sure to provide sufficient information to support the drafting of Chinese product standard by the registration agent Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 14
  15. 15. Product Standard (cont’d) ❖ The product standard should describe the product and include the appropriate Chinese standards it complies with. ❖ Many of the Chinese standards correspond to international standards. ❖ Standard Classifications ♦ National Standards (GB, GB/T) ♦ SFDA Standards or Industry Standards (YY, YY/T) ♦ Product Registration Standards (ZCB) ❖ Standard Categories ♦ Basic Standards ♦ Safety Standards ♦ Product Standards Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 15
  16. 16. Type Testing ❖ In almost all situations, the SFDA will request samples for type testing. ❖ The testing centers will use the Product Standard to determine what tests to conduct. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 16
  17. 17. Bundling Products ❖ Bundling accessories with products is possible for registration. ❖ Make sure to develop Product Standard accordingly. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 17
  18. 18. Renewing Your Registration ❖ Product registration is valid for 4 years. ❖ Renewal application must be submitted 6 months before import license expires. Start process 1 year in advance. ❖ Renewal process is similar to a new application. ❖ Sample testing should be repeated again. ❖ Post-market quality and safety surveillance report is required. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 18
  19. 19. Registration Requirements for Dossier ❖ Total 13 items of documents must be collected and submitted to the SFDA. ❖ Three parts of these 13 items: ♦ Legal Documents (9). ♦ Technical Documents (3). ♦ Testing report issued by SFDA certified testing center (if applicable). ❖ Documents must be in both Chinese and English. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 19
  20. 20. Testing Report ❖ Testing Report: ♦ Issued by SFDA certified testing center. ♦ Testing Center can be freely selected from the SFDA list. ♦ Must be valid (the testing report is only valid for 1 year). So if it expires, you need to start again. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 20
  21. 21. Adverse Event Reporting for MDs ❖ Strengthening Adverse Drug Reaction Monitoring ❖ Specifies which governmental agencies are responsible for which aspects of medical device adverse event monitoring and re-evaluation ❖ All medical device manufacturers, distributors, and medical institutions must establish internal supervision systems for medical device adverse event monitoring. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 21
  22. 22. Clinical Trials for Products Not Yet Registered in China ❖ The SFDA has been organizing expert review meetings with top doctors to determine if clinical trials are required for product registration. ❖ More and more, the SFDA has been getting stricter in requiring local clinical trials, even for some Class II products. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 22
  23. 23. Clinical Trials in China ❖ All clinical trials (if necessary) for medical devices must follow China’s Good Clinical Practices (GCP). ❖ Regulation on Medical Device Clinical Trial Requirements became effective April 2004. ❖ Can only draw on previous clinical trial experiences of similar products. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 23
  24. 24. Thank You! Pacific Bridge Medical Connect with us today. 7315 Wisconsin Avenue, Suite 609E Bethesda, MD 20814 www.pacificbridgemedical.com Click here to contact us for medical device regulatory assistance in China. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 24

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