China\'s Medical Device Regulatory Process

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This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.

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China\'s Medical Device Regulatory Process

  1. 1. for the USA, EU and China Ibim Tariah   John Beasley   Kevin Morningstar Presenters
  2. 2. John Beasley CHINA MEDICAL DEVICE REGULATORY PROCESS
  3. 3. Please Note The information contained in this presentation is intended for general regulatory planning. China’s regulatory system is currently under change. Companies are strongly encouraged to work with professional organizations familiar with the most current regulatory environment for their specific needs. Translations of laws and regulations are unofficial.
  4. 4. Topics •  Regulatory Agencies in China •  Summary of Laws and Regulations •  Labeling Requirements •  Important Documentation and Procedures Presented in relation to Summary Technical Document (STED) of GHTF
  5. 5. connections 关 Guanxi relationships a state of general understanding between two individuals: “he is aware of my needs and will take them into account when deciding the course of future actions which concern or could concern me without any specific discussion or request”. 关 is the basic dynamic in personalized networks of influence
  6. 6. Regulatory Agencies in China •  Three Chinese agencies have regulatory roles for imported medical devices. –  State Food and Drug Administration (SFDA) –  Ministry of Health (MOH) –  General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) 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 Administration (CNCA)
  7. 7. Websites Agency   Website   SFDA   h'p://www.sfda.gov.cn   AQSIQ   h'p://www.aqsiq.gov.cn   MOH   www.moh.gov.cn    
  8. 8. English  
  9. 9. English? Updated monthly PR Announcements Some translations of regulations provided (in “Chinglish”)
  10. 10. Which version of the standard? •  •  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 the 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 instructions, labels and packaging of the product.
  11. 11. Frustrated Industry
  12. 12. State Food and Drug Administration •  Regulation of medical devices •  Roughly equivalent to the U.S. Food and Drug Administration •  All imported medical devices must get a registration certificate from SFDA •  The SFDA has a comprehensive system for medical device registration and inspection, which includes product type testing and factory audits.
  13. 13. Ministry of Health •  The Ministry of Health (MOH) is in charge of –  drafting laws, regulations, and policies related to public health, –  overseeing the administration of Traditional Chinese Medicine, and –  for administering China’s rural health insurance system.
  14. 14. General Administration of Quality Supervision, Inspection and Quarantine •  AQSIQ is tasked with overseeing inspection, quarantine, and establishing the technical standards of goods for import and export. •  AQSIQ maintains responsibility for certifying electrical safety for a wide variety of products, including some electro-medical devices
  15. 15. Laws and Regulations •  The Regulations for the Supervision and Administration of Medical Devices, Order 276, enacted in April 1, 2000, is the fundamental law governing China’s health sector. –  The regulations have been amended on several occasions by RED LETTERS
  16. 16. Amendments
  17. 17. Amended Order 276 •  September 6, 2010 •  Regulation on Supervision and Administration of Medical Devices (Amendment Bill) –  (Draft for Public Comment) •  Consolidation of –  Red Letters –  Clinical Trail, Manufacturing, Recall, and other regulations Increases from Six Chapters, Forty-eight Articles to Nine Chapters, Eighty-eight Articles
  18. 18. Labeling Requirements •  On July 8, 2004, SFDA issued a regulation titled “Provisions for the Instructions, Labels and Package of Medical Devices” which lays out requirements for labeling. –  must be labeled in Chinese –  include the registration certificate number –  product features –  the scope of usage for the product These labels should be affixed to products before going through customs.
  19. 19. Labeling Prohibitions •  “Best effect of treatment", •  "Full recovery guarantee", •  "Immediate effect", •  "Without toxicity and side-effect”, •  "Money back if not effective”, •  “Highest technology", •  “Most scientific", •  “Most advanced”, and •  “The best”.
  20. 20. In addition … •  Specifications, labels and marks of medial devices can not state –  cure rate or efficacy rates, –  comparisons to the efficacy and safety of one manufacturer’s products with another’s. –  any firm’s or individual’s name or image for the purpose of approval or recommendation –  expressions which make people feel that they have attracted certain disease, or –  expression which mislead people into feeling that they would contract a certain disease, or their disease could get worse by not using this medical device.
  21. 21. Who Submits the Registration Application •  China issues registration certificates and licenses in the name of the device manufacturer –  not to the agent or distributor. Companies should arrange for their agent or distributor to hand over the registration certificates (licenses).
  22. 22. What Medical Devices Need to be Registered •  Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration; •  Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness •  Class III Medical Devices are 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. Class I devices are RECORDED; Class II and Class III devices are REGISTERED
  23. 23. What Risk Category is the Device?
  24. 24. What Risk Category is the Device? •  Three characteristics described in guidelines –  (1) The structural characteristics of medical devices •  Active or Passive –  (2) The forms of operation of medical devices •  Passive devices are used for transportation and storage of pharmaceutical liquid; devices for alteration of blood or body fluids; medical dressings; reusable or disposable surgical instruments; disposable aseptic devices; implantable devices; devices for contraception and birth control; devices for sterilization and cleaning; patient care devices; in vitro diagnostic reagents as well as other passive contacting devices or passive supplementary devices
  25. 25. What Risk Category is the Device? –  (2) The forms of operation of medical devices (continued) •  Active devices are devices for treatment through energy, diagnostic monitoring, body fluid transportation and ionized radiation, laboratory instruments and medical sterilizer; as well as other active contacting devices or active supplementary devices.
  26. 26. What Risk Category is the Device? –  (3) The conditions for use of medical devices •  Contacting or inserted devices –  Term of use: temporary use, short - term use, long-term use; –  Particular parts of the human body being contacted: skin, cavity and tract; trauma or body tissue; blood circulation system or central nervous system; –  The degree of injuries caused by malfunction of active devices: minor injuries, injuries, serious injuries. •  Non-contacting Devices SFDA also has a classification catalogue for medical devices (in Chinese) which provides more information regarding which classification a device falls under.
  27. 27. How to Demonstrate Conformance with Chinese Standards •  Chinese law requires each industrial product to have a Chinese national standard. –  The Chinese national standard is usually the same as the relevant international standard, although sometimes with minor modifications. –  Medical devices type testing must be based upon the Chinese national standard.
  28. 28. How to Demonstrate Conformance with Chinese Standards •  However, if a national standard does not exist, an industry standard, or a company-specified standard may be used. •  Chinese testing laboratories work with companies to ensure that their company-specific standard are in-line with relevant national standards.
  29. 29. •  The medical device standards are classified as –  national standards (GB), –  industry standards (YY) and –  registration product standards (YZB).
  30. 30. Standards •  China medical devices standards are separated into compulsory standards and recommended standards, which differ from international standards. –  The difference in the standard code between compulsory standards and recommended standards is whether “/T” follows GB or YY. •  GB and YY are compulsory standards •  GB/T and YY/T are recommended standards Compulsory standards have the attribute of law and must be implemented.
  31. 31. Example: Infusion Pump
  32. 32. Example: Infusion Pump
  33. 33. Compulsory Identical to ISO; Otherwise would read MOD
  34. 34. Standards •  National standards are established and applied for regulating technology requirements nationwide. •  Industry standards are established for certain industries which has no national standards but need standard technology requirements within the industry. •  Registration product standard is a document developed from technical documents/standards, presented when applying for medical device product registration, which states the quality and technical requirements for declared products.
  35. 35. Internet Resources •  National medical devices standards can be found at National Standardisation Technical Committees' website –  www.sac.gov.cn •  Industry standards can be found at State food and Drug Administration website –  www.sfda.gov.cn •  and Centre for Medical Device Evaluation –  www.cmde.org.cn
  36. 36. Testing Labs •  For first-time registration with SFDA, a company is required to provide a testing report for the product by a Chinese lab and clinical trial report (for certain high risk products) with clinical data based on the clinical trials from two medical institutions. The company is also required to submit a product standard according to China’s “Product Regulation Standard”, for SFDA’s record. •  If a laboratory cannot test a device (due to the lack of a Chinese National Standard, or because the company- specific standard is beyond the lab’s testing capability), SFDA will accept tests conducted in the product’s country of origin.
  37. 37. Testing Labs •  However, U.S. companies have noted that in the past these laboratories have required that the company-specific product standard (product specifications, testing methods and specifications) be submitted for review and approval prior to testing being done by the lab. •  In some cases, labs have insisted that the company-specific product standard did not meet their format, and have tried to get companies to pay a fee to have the standard re-written in a manner that makes it possible for the lab to do the test itself. •  In the past, laboratories often attempted to perform the required testing without the proper facilities or knowledge, which were not always accepted by SFDA. In many cases, SFDA found those tests to be insufficient and requires new tests. Although labs are required to complete their testing within one month, this often takes between 4 to 5 months to complete.
  38. 38. Testing Labs •  SFDA has certified ten testing laboratories as technologically competent to perform the required tests in an effort to alleviate these problems.
  39. 39. Testing Labs •  Beijing Center for Medical Device Quality Supervision and Testing •  Medical Device Quality Supervision and Testing Center of Peking University ( Beijing) •  Center for Medical Devices - National Institute for the Control of Pharmaceutical -- Biological Products ( Beijing) •  Shanghai Center for Medical Equipment Quality Supervision and Testing •  Tianjin Medical Instrumentation Inspection Center •  Wuhan Quality Supervision and Testing Center for Medical Devices •  Jinan Quality Supervision and Inspection Center for Medical Devices •  Shenyang Center for Medical Equipment Quality Supervision and Testing •  Guangzhou Quality Supervision and Inspection Center for Medical Instruments •  Hangzhou Center for Medical Equipment Quality Supervision and Testing
  40. 40. Test Labs •  With the medical device industry’s rapid growth, however, the centers have been hard-pressed to keep up with increasing demand. •  As SFDA has tightened regulations and raised medical device registration standards, the centers have had to perform significantly more tests more thoroughly. •  Current testing facilities have insufficient resources to meet these requirements efficiently, prompting industry complaints about the slow registration process.
  41. 41. "China Compulsory Certification” •  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 officials at the applicant’s expense, as well as follow-up inspections.
  42. 42. The Regulations for the Supervision and Administration of Medical Devices, Order 276 Article 8 The State shall implement a product registration system for the manufacturing of medical devices.
  43. 43. Making use of the STED Borrowing from the Pharmaceutical CTD Triangle
  44. 44. Making use of the STED 1.  Application form 2.  Business license of manufacturer 3.  Letter of authorization for registration agent Module  1:   4.  Letter of authorization for after-sales agent Geographic   5.  Letter of promise from after-sales agent 6.  Quality Guarantee Letter Specific   7.  Truthful and Accuracy of Submission Statement DocumentaGon   8.  Fees Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  45. 45. Making use of the STED 1.  Outline of device 2.  Origin/history of discovery and development history Module  1:   3.  Use in foreign counties (complaint information) 4.  Manufacturing authorization document in the country of origin Geographic   Specific   DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  46. 46. Making use of the STED 1.  List of referenced standards (GB, YY, GB/T, etc.) 2.  Check list of conformity Module  1:   3.  Description of conformity Geographic   Specific   DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  47. 47. Making use of the STED 1.  General information/materials 2.  Specifications and rationale Module  1:   3.  UBD and storage condition Geographic   4.  Comparison to predicate device Specific   DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  48. 48. Making use of the STED 1.  Conformity declaration to standards and QS regulations 2.  Design verification related to safety 3.  Performance data Module  1:   4.  Clinical data Geographic   5.  YZB Report from Type Test Lab Specific   DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  49. 49. Making use of the STED 1.  Final Draft IFU Module  1:   2.  Rationale of indication 3.  Rationale of operation method Geographic   4.  Rationale of precautions Specific   5.  China regulatory labeling specifics DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  50. 50. Making use of the STED Module  1:   1.  Organization of risk management Geographic   2.  Conduct of risk analysis Specific   3.  Critical hazard and correction actions DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  51. 51. Making use of the STED Module  1:   1.  Manufacturing process flowchart Geographic   2.  Sterilization method Specific   3.  Information on quality control DocumentaGon   Section 1: Summary of Device and Approvals Section 2: Section 3: Device Section 4: Essential Description Design V&V Principles Documents Section 5: Labeling, Section 7: Section 6: Risk Instructions, Manufacturing Analysis Advertisement Information
  52. 52. GROUP EXERCISE IBIM TARIAH

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