Medical device regulation between us and china


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medical devices regulation in APAC / China - SFDA - FDA, market entry, forecast,

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Medical device regulation between us and china

  1. 1. L/O/G/O Medical Device Regulation between China and US Tony Hussey & Mingzi Deng
  2. 2. 1. Background - Rapid Developing China In 2009, the sum of imports and exports 2347 billion USD 47% of GDP 2009 – 4984 billion USD 2010 – 5738 billion USD Source: World Bank
  3. 3. 2. Chinese Medical Device Industry Snapshot 2.1 The Current Medical Device Market • 6.2 billion USD in 2005; annual 16 percent expanding (Osec Business Network Switzerland) • 13.7 billion USD in 2006; 12.9% increasing (Espicom Business Intelligence) • 6.6 billion USD in 2004; 7.3 billion USD in 2005; annual 9 percent increasing (NDRC)
  4. 4. 2.2 Forecast and potential market (1) • annual growth rate of the market in the period 2006-2011 is predicted to be 11.1% (Espicom Business Intelligence) • Annual growth rate 9% (NDRC)
  5. 5. 2.2 Forecast and potential market (2) • Only meets approximately 60 percent of the demand (Osec Business Network Switzerland) • Manufacturers ——19.5 percent increasing, from 356 in 1985 to 10,447 in 2004 (Osec Business Network Switzerland).
  6. 6. 2.3 Where is the medical device industry located? Circum- Bohai-Sea Region Yangtze River Delta Pearl River Delta
  7. 7. 2.4 Where are the medical devices imported from?
  8. 8. 3. Medical Devices Regulatory Authority in China and US
  9. 9. Comparison
  10. 10. 4. The Comparison of Medical Device Definition 1. China - Medical used software US - “General Principles of Software Validation” - Center for Devices and Radiological Health (CDRH) 2. China - “Product Classification Catalog of Medical Devices” US - The U.S. Pharmacopoeia - database 3. China - Veterinary Department under the Ministry of Agriculture US- “the other animals” 4. China - control of conception US - none
  11. 11. 5. The Differences of Medical Devices Administration System in China and US “Federal Food, Drug, and Cosmetic Act (FD&CA)”, “Fair Packaging and Labeling Act”, “Medical Device Regulation Act”, “Food and Drug Administration Modernization Act”, “Medical Device User Fee and Modernization Act (MDUFMA).” • Provisions on Classification of Medical Devices (No.15) • Provisions on Medical Device Registration (No. 16) • Provisions on New Medical Device Approval (Interim) (No. 17) • Provisions on Medical Device Manufacturing Supervision & Administration (No. 12) • Provisions on Medical Device Distributor Licensure Administration (No. 15) • Provisions on Medical Device Manufacturing Enterprise Quality System Inspection (No. 22) • Provisions on Single Use Sterile Medical Device Supervision & Administration (Interim) (No. 24) • Provisions on Instruction for Use and Labeling of Medical Devices (No. 10) • Provisions on Medical Device Standardization (No.31) • Provisions on Clinical Trial of Medical Devices (No.5) Regulations on Supervision and Management to Medical Instruments (Decree of the State Council No. 276) 5.1 The Legal Status
  12. 12. 5.2 The Administration Status • National level - Provincial level - City and country levels
  13. 13. 5.3 The Way On Dealing With Adverse Events • FDA - Correction and Punishment Recalling & Sending a warning letter • SFDA - Punishment
  14. 14. L/O/G/O Chinese Medical Devices Industry Challenges and opportunities Jiafeng Tu, Mingzi Deng
  15. 15. Market Entry Requirement Click to add title in here Click t add title in here2 State Food and Drug Administration (SFDA) Registration China Compulsory Certification (CCC) -Product safety, electrical interference and operator’s safety
  16. 16. Market Entry Requirement Click to add title in here Click t add title in here2 NO means NO PERMISSION to market. NO means NO IMPORTATION into China.
  17. 17. About SFDA • State Food and Drug Administration (SFDA) founded in 2003, directly led by the State Council of P. R. China; • Local Agencies: 31 provincial-, 433 municipality-,1,936 county- level agencies (2,401 total); • Technical Organizations: 16 state-, 122 provincial-, 373 municipality-, 436 county- level organizations (947 total)
  18. 18. About • Seven categories of electro-medical device products require CCC certification • Electrocardiographs; • Hemodialysis equipment • Extracorporeal blood circuit for blood purification equipment; • Hollow fiber dialyzer; • Implantable cardiac pacemakers; • Medical x-ray diagnostic equipment; • Artificial heart-lung machine. CCC mark certification requires a factory inspection by Chinese official at the applicant’s expense, as well as follow-up inspections.
  19. 19. Regulatory agencies in China Three Chinese agencies have regulatory roles for imported medical devices. •State Food and Drug Administration (SFDA) Comprehensive system for medical device registration •Ministry of Health (MOH) •General Administration of Quality Supervision Inspection and Quarantine (AQSIQ) Maintains responsibility for certifying electrical safety for a wide variety of products • Involvement of other agencies is required for specific devices • i.e., Safety Quality Licensing Office for Import Boiler and Pressure Vessels (SQLO) certificates, China National Certification and Accreditation Admnistration (CNCA) *For more information about those agency , please see webpage or materials on blackboard.
  20. 20. Challenges in China Laws and regulations are constantly changing Limited official announcements Much more Complex Relationships4 1 2 3
  21. 21. SFDA web in Chinese version The SFDA website is using Chinese as official language. ENGLISH
  22. 22. English? • Updated monthly • Simple Announcements • Some translations of regulations provided (in “Chingling”)
  23. 23. Frustrated Industry
  24. 24. Which version of the standard? • 二、对于产品标准采用或引用的国 家标准或行业标准发生变化的,除 因标准变化的内容对产品安全性、 有效性有实质影响,国家食品药品 监督管理局在发布、实施国家标准 或行业标准的文件中另有规定外, 在新标准实施之日前受理注册检测 的产品,仍按照原标进行检测、审 评和审批,但企业应当在取得医疗 器械注册证后,自新标准实施之日 起,按照新标准组织生产,在产品 说明书、标准、标签、包装标识中 仍标注批准注册时核准的产品标准 编号。 • 2. Should changes occur to the national standards or industry standards for which the product standards are adopted from or referenced from, those medical devices which had received registration approval before the issuance of new standards shall be examined, reviewed and approved according to the original standards, except in situations whereby the safety and efficacy of the medical device would be substantially affected by the changed standards, and when other requirements already exist in regulations within SFDA- released and implemented national or industry standards. • However, after the company has acquired the registration certificate and upon the validation of the new standards, the medical device should be manufactured according to the new version, and the product standard code of approval must be included in the product industries, labels and packaging of the product.
  25. 25. Laws and Regulations • the fundamental law governing China’s health sector. • The regulations have been amended on several occasions by RED LETTERS enacted in April 1, 2000 Amended Order 276 Sep. 6, 2010 •Regulation on Supervision and Administration Medical Devices (Amendment Bill) •Consolidation of -Red Letters -Clinical Trail, Manufacturing, Recall, and other regulations •6 chapters, 48 articles 9 chapters, 88 articles Order 276 --The Regulations for the Supervision and administration of Medical Devices
  26. 26. RED LETTER
  27. 27. Opportunity in China Medical System Reform Drives RMB 16B Medical Device Investment The new medical and health system reform scheme was announced on April 6, 2009. According to this scheme, China will invest RMB 850 billion to promote medical and health system reform during 2009~2011. This big cake of new medical and health system reform has triggered competition between domestic and international medical device and medical software manufacturers. Industrial income and profits of China medical device industry (unit: RMB100 million) Source: State Statistic Bureau Development Opportunity During 2003~2007, the annual growth rate of industrial sales revenues reached 27.08% and the annual growth rate of profit went up to 33.73%. In 2007, China had in total 298 private medical device enterprises, 240 foreign and Hong Kong, Macao and Taiwan invested enterprises, only 36 state-owned enterprises and 25 collective enterprises.
  28. 28. General situation of the Medical Device Export Market in China By January 2010, China has exported medical devices to 186 countries and regions, with the exports amounting to US$ 1.0199751 billion. There were 19 countries and regions to which more than US $10 million was exported. The top ten export countries and regions accounted for 66% of the exports. Source: State Statistic Bureau
  29. 29. China Medical Regulatory Opportunities • SFDA and CCC are recognized by the public. • Competitive advantages • Product classification • Duty rates: MD vs. IT Stay Informed, Compliant, Competitive …Stay Informed, Compliant, Competitive …
  30. 30. References • Ministry of Labor and Social Security: The Ministry of Labor and Social Security is in charge of making BHIS formulary. • About the Center for Devices and Radiological Health. FDA. Accessed by Nov 23, 2010. • China Medical Devices Research Report. 2007. Access by Nov 23, 2010. • Espicom Business Intelligence (EBI). The Chinese medical device market: Facts and figures. China: Accessing Medical Device Market. July 2007 • National Development and Reform Commission (NDRC). The Research Proposal of Chinese Medical Device M and Price evaluation. 2005. • Osec Business Network Switzerland (OBNS). Market Report: Medical Device Market in China 2007. File.File.pdf/BB_Marktstudie_Medical_Device_Market_in_China_070215.pdf. Access by Nov 23, 2010. • Part 860. Code of Federal Regulations Title 21 (21CFR). FDA. • Accessed by Nov 23 • Regulations for the Supervision and Administration of Medical Devices. State Food and Drug Administration (S P.R.China. Jan 4, 2000. • Access by Nov 23, 2010. • Report on China's medical device market and investment. The Medical News. Sep 8, 2009 • Access by Nov 23, 2010. • State Food and Drug Administration (SFDA). 医疗器械监督司 . • . Accessed by Nov 23, 2010. • The World Bank. 2009. Accessed by Nov 23, 2010.
  31. 31. L/O/G/O Thank You! Mingzi Deng