Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.

Strategies for Device Approval in China, India, South Korea and Australia

This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.

  • Loggen Sie sich ein, um Kommentare anzuzeigen.

Strategies for Device Approval in China, India, South Korea and Australia

  1. 1. Strategies for getting your device approved in Australia, China, India and South Korea Presented by: Evangeline Loh, Ph.D. RAC (US, EU) Vice President, Global Regulatory Affairs Austin, Texas office evangeline@emergogroup.com
  2. 2. What we will cover AUSTRALIA CHINA INDIA SOUTH KOREA
  3. 3. Medical device registration in Australia
  4. 4. Australian market appeal • Population of 23 million. • 12th largest global economy, about the same as Canada. • Device market totals US$ 5-7 billion. • Expected to decrease 2.3% annually. • A weakening Australian dollar will slow market growth in coming years.
  5. 5. Australian regulatory process for medical devices • Regulated by the Australian Therapeutic Goods Administration (TGA), within the Australian Department of Health. • Legal framework for the regulatory system is based on the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulation 2002. • Medical devices must meet the requirements of the Act and Regulation before being sold in the country.
  6. 6. Overview of regulatory process, 1 of 2 Appoint Sponsor Prepare technical file Classify your device
  7. 7. Overview of regulatory process, 2 of 2 Submit Manufacturer’s Evidence Submit materials Start exporting! Await review completion
  8. 8. Timeline to approval Download this chart: http://www.emergogroup.com/resources/australia-process-chart
  9. 9. disc
  10. 10. CHINA
  11. 11. https://www.ebs.tga.gov.au/servlet/xml millr6?dbid=ebs%2FPublicHTML%2FpdfS tore.nsf&docid=1EB8DD812E3197BACA2 577DD00029D5F&agid=(PrintDetailsPubl ic)&actionid=1
  12. 12. Australian Orthopedic Association National Joint Replacement Registry (AOANJRR) • Funded Department of Health • Data collection commenced Sept 1999 • Expanded to include shoulder, elbow, wrist, ankle and spinal disc replacement 2007 • Objective “define, improve and maintain the quality of care of individuals receiving joint replacement surgery”
  13. 13. Demographics of Spinal Disc Replacement
  14. 14. Primary Spinal Disc Replacement
  15. 15. China
  16. 16. Chinese market appeal • Population of 1.4 billion. • 2nd largest global economy. • Device market totals $17.2 billion. • Expected to grow 7.4% annually. • China’s 13th Five-Year Plan will inspire growth in the healthcare industry. • 4th largest medical device market in the world.* * www.espicom.com
  17. 17. Chinese regulatory process for medical devices • Regulated by the China Food and Drug Administration (CFDA), within the State Council of the People’s Republic of China. • First established in 1950 as State Food and Drug Administration (SFDA), rebranded and restructured in 2013 as the CFDA. • Medical devices must meet the requirements of Regulations for the Supervision and Administration of Medical Devices (State Order No. 650) before being sold in the country.
  18. 18. Overview of regulatory process, 1 of 2 Appoint agent Complete testing Prepare technical file Classify your device Submit QMS certification
  19. 19. Overview of regulatory process, 2 of 2 Prepare clinical data Submit materials Start exporting! Await review completion
  20. 20. “Innovation product” • No similar products have been registered in CFDA. • Product is patented in China. • Product is significant in clinical application or economic aspects. • Manufacturer has country of origin/home country approval. • Applicant and CFDA appraiser will be permitted to meet and discuss the product and application. • CFDA regulatory review is expedited.
  21. 21. Clinical Evaluation (CFDA Order No. 4) • Clinical Evaluation of devices exempted from clinical trial – Clinical Trial Exemption Catalogs for Class II and Class III • Clinical Evaluation through comparison with “equivalent device” – Comparison table with equivalent device legally marketed in China • Clinical Trial Medical Device Registration Supervision, www.cfda.gov.cn/WS01/CL0053/103756.html
  22. 22. Timeline to approval Download this chart: http://www.emergogroup.com/resources/china-process-chart
  23. 23. http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=27&tableName=TABLE27&title=%BD%F8%BF% DA%C6%F7%D0%B5&bcId=118103063506935484150101953610 expedium
  24. 24. India
  25. 25. Indian market appeal • Population of 1.2 billion. • 9th largest global economy, about the same as Italy. • Device market totals $4 billion. • Expected to grow 7.3% annually. • Federal funding will bolster the healthcare industry, despite declines in exports.
  26. 26. Indian Regulatory Process for Medical Devices • Regulated by the Drug Controller General of India (DCGI), within the Central Drugs Standard Control Organization (CDSCO). • Legal framework for the regulatory system is based on the Drugs and Cosmetics Act of 1940, and Drugs and Cosmetics Rules of 1945. • A limited number of medical devices must meet the requirements of the organization before being sold in the country, including orthopedic implants.
  27. 27. Overview of regulatory process, 1 of 2 Appoint agent Complete testing Compile application Does your device require registration?
  28. 28. Overview of regulatory process, 2 of 2 Submit application Wait for approval Start exporting! Receive certificate
  29. 29. Regulatory Strategy • Legal and actual manufacturers need to be reported to CDSCO, both included on the Registration Certificate and labeling • Actual manufacturer is site of “final batch release”/QC of the medical device • If legal is not actual, consider legal performing final batch release/QC and issuing Certificate of Analysis http://www.cdsco.nic.in/writereaddata/FAQ-IMPORT-&- REGISTRATION-02022013_DONEE.pdf
  30. 30. Registration Certificates Issued for Medical Devices, 2015 Legal Manufacturer: Stryker Spine, USA Actual Manufacturer: Stryker SAS, France http://www.cdsco.nic.in/writereaddata/mdRC_2015.pdf http://www.cdsco.nic.in/Forms/list.aspx?lid=1758
  31. 31. SEC Orthopedic Meeting Outcomes http://www.cdsco.nic.in/forms/list.aspx?lid=20 02&Id=32 Synopsis recommendations from meeting 28 January 2015
  32. 32. http://www.cdsco.nic.in/writereaddata/MDAC -SEC%20Orthopedics%20Minutes%2028-01- 2015.pdf CDSCO will grant RC, need PMS data from India (every 0.5years, next 3years)
  33. 33. Timeline to approval Download this chart: http://www.emergogroup.com/resources/india-process-chart
  34. 34. South Korea
  35. 35. South Korean market appeal • Population of 50 million. • 13th largest global economy, about the same as Mexico. • Device market totals $5.4 billion. • Third largest medical device market in Asia Pacific region.* • Expected to grow 5.2% annually. • Aging population and economic growth will result in demands for better healthcare. * www.espicom.com
  36. 36. South Korean regulatory process for medical devices • Regulated by the Ministry of Food and Drug Safety (MFDS). • Legal framework for the regulatory system is based on the Medical Devices Act No. 13698. • Medical devices must meet the requirements of the Act before being sold in the country.
  37. 37. Overview of regulatory process, 1 of 2 Classify your device Appoint license holder Meet KGMP requirements Submit testing data
  38. 38. Overview of regulatory process, 2 of 2 Prepare submission Submit dossier Wait for approval Start exporting!
  39. 39. Clinical Evaluation (MFDS Notification No. 2015-114, Article 12) • Data from institution designated by MFDS • Foreign data performed according to KGCP and compliant to SKR legislation • Clinical trial data from OECD member country and reviewed and approved trusted regulatory authority • Data published journal academic society listed Science Citation Index • For Class I and Class II devices, acceptable to submit test reports for equivalent devices Approval, Notification and Review of Medical Devices, December 2015
  40. 40. Timeline to approval Download this chart: http://www.emergogroup.com/resources/south-korea-process-chart
  41. 41. https://emed.mfds.go.kr/#!CECAB01F010
  42. 42. Questions? Please contact: Evangeline Loh, Ph.D., RAC Vice President, Global Regulatory Affairs evangeline@emergogroup.com Thank you for your attention

×