strategies for device approval in china, india, south korea and australia
TRANSCRIPT
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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 [email protected]
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What we will cover
AUSTRALIA
CHINA
INDIA
SOUTH KOREA
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Medical device registration in Australia
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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.
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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.
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Overview of regulatory process, 1 of 2
Appoint Sponsor
Prepare technical file
Classify your device
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Overview of regulatory process, 2 of 2 Submit Manufacturers Evidence
Submit materials
Start exporting!
Await review completion
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Timeline to approval
Download this chart: http://www.emergogroup.com/resources/australia-process-chart
http://www.emergogroup.com/resources/australia-process-chart
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disc
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CHINA
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https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs%2FPublicHTML%2FpdfStore.nsf&docid=1EB8DD812E3197BACA2577DD00029D5F&agid=(PrintDetailsPublic)&actionid=1
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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
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Demographics of Spinal Disc Replacement
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Primary Spinal Disc Replacement
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China
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Chinese market appeal
Population of 1.4 billion. 2nd largest global economy. Device market totals $17.2 billion. Expected to grow 7.4% annually. Chinas 13th Five-Year Plan will inspire
growth in the healthcare industry. 4th largest medical device market in the
world.* * www.espicom.com
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Chinese regulatory process for medical devices
Regulated by the China Food and Drug Administration (CFDA), within the State Council of the Peoples 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.
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Overview of regulatory process, 1 of 2
Appoint agent
Complete testing
Prepare technical file
Classify your device
Submit QMS certification
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Overview of regulatory process, 2 of 2 Prepare clinical data
Submit materials
Start exporting!
Await review completion
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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.
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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
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Timeline to approval
Download this chart: http://www.emergogroup.com/resources/china-process-chart
http://www.emergogroup.com/resources/china-process-charthttp://www.emergogroup.com/resources/china-process-charthttp://www.emergogroup.com/resources/china-process-charthttp://www.emergogroup.com/resources/china-process-charthttp://www.emergogroup.com/resources/china-process-chart
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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
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India
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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.
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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.
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Overview of regulatory process, 1 of 2
Appoint agent
Complete testing
Compile application
Does your device require registration?
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Overview of regulatory process, 2 of 2 Submit application
Wait for approval
Start exporting!
Receive certificate
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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
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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
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SEC Orthopedic Meeting Outcomes
http://www.cdsco.nic.in/forms/list.aspx?lid=2002&Id=32
Synopsis recommendations from meeting 28 January 2015
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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)
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Timeline to approval
Download this chart: http://www.emergogroup.com/resources/india-process-chart
http://www.emergogroup.com/resources/india-process-chart
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South Korea
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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
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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.
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Overview of regulatory process, 1 of 2
Classify your device
Appoint license holder
Meet KGMP requirements
Submit testing data
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Overview of regulatory process, 2 of 2 Prepare submission
Submit dossier
Wait for approval
Start exporting!
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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
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Timeline to approval
Download this chart: http://www.emergogroup.com/resources/south-korea-process-chart
http://www.emergogroup.com/resources/south-korea-process-chart
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https://emed.mfds.go.kr/#!CECAB01F010
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Questions? Please contact: Evangeline Loh, Ph.D., RAC Vice President, Global Regulatory Affairs [email protected]
Thank you for your attention
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Strategies for Device Approval in China, India, South Korea, and AustraliaOMTEC-2016_Loh_Strategies-Device-Approval.pdfSlide Number 1What we will coverMedical deviceregistration in AustraliaAustralian market appealAustralian regulatory process for medical devicesSlide Number 6Slide Number 7Slide Number 8Slide Number 9CHINASlide Number 11Australian Orthopedic Association National Joint Replacement Registry (AOANJRR)Demographics of Spinal Disc ReplacementPrimary Spinal Disc ReplacementChinaChinese market appealChinese regulatory process for medical devicesSlide Number 18Slide Number 19Innovation productClinical Evaluation (CFDA Order No. 4)Slide Number 22Slide Number 23Slide Number 24IndiaIndian market appealIndian Regulatory Process for Medical DevicesSlide Number 28Slide Number 29Regulatory StrategySlide Number 31SEC Orthopedic Meeting OutcomesSlide Number 33Slide Number 34South KoreaSouth Korean market appealSouth Korean regulatory process for medical devicesSlide Number 38Slide Number 39Clinical Evaluation (MFDS Notification No. 2015-114, Article 12)Slide Number 41https://emed.mfds.go.kr/#!CECAB01F010Slide Number 43Slide Number 44Slide Number 45Slide Number 46
Online closing side OMTEC 2016 speaker presentations