strategies for device approval in china, india, south korea and australia

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]

What we will cover

AUSTRALIA

CHINA

INDIA

SOUTH KOREA

Medical device registration in Australia

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.

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.

Overview of regulatory process, 1 of 2

Appoint Sponsor

Prepare technical file

Classify your device

Overview of regulatory process, 2 of 2 Submit Manufacturers Evidence

Submit materials

Start exporting!

Await review completion

Timeline to approval

Download this chart: http://www.emergogroup.com/resources/australia-process-chart

http://www.emergogroup.com/resources/australia-process-chart

https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs%2FPublicHTML%2FpdfStore.nsf&docid=1EB8DD812E3197BACA2577DD00029D5F&agid=(PrintDetailsPublic)&actionid=1

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

Demographics of Spinal Disc Replacement

Primary Spinal Disc Replacement

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

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.


Appoint agent

Complete testing

Prepare technical file


Submit QMS certification

Overview of regulatory process, 2 of 2 Prepare clinical data

Submit materials

Start exporting!

Await review completion

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.

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


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

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

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.

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.


Appoint agent

Complete testing

Compile application

Does your device require registration?

Overview of regulatory process, 2 of 2 Submit application

Wait for approval

Start exporting!

Receive certificate

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

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

SEC Orthopedic Meeting Outcomes

http://www.cdsco.nic.in/forms/list.aspx?lid=2002&Id=32

Synopsis recommendations from meeting 28 January 2015

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)


Download this chart: http://www.emergogroup.com/resources/india-process-chart

http://www.emergogroup.com/resources/india-process-chart

South Korea

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

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.



Appoint license holder

Meet KGMP requirements

Submit testing data

Overview of regulatory process, 2 of 2 Prepare submission

Submit dossier

Wait for approval

Start exporting!

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


Download this chart: http://www.emergogroup.com/resources/south-korea-process-chart

http://www.emergogroup.com/resources/south-korea-process-chart

https://emed.mfds.go.kr/#!CECAB01F010

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

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strategies for device approval in china, india, south korea and australia

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