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.
What we will cover
AUSTRALIA
CHINA
INDIA
SOUTH KOREA

3.
Medical device
registration in Australia

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.
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.
Overview of regulatory process, 1 of 2
Appoint
Sponsor
Prepare
technical file
Classify your
device

7.
Overview of regulatory process, 2 of 2
Submit
Manufacturer’s
Evidence
Submit
materials
Start
exporting!
Await review
completion

8.
Timeline to approval
Download this chart:
http://www.emergogroup.com/resources/australia-process-chart

9.
disc

10.
CHINA

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.
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.
Demographics of Spinal Disc Replacement

14.
Primary Spinal Disc Replacement

15.
China

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.
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.
Overview of regulatory process, 1 of 2
Appoint
agent
Complete
testing
Prepare
technical file
Classify your
device
Submit QMS
certification

19.
Overview of regulatory process, 2 of 2
Prepare
clinical
data
Submit
materials
Start
exporting!
Await review
completion

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.
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.
Timeline to approval
Download this chart:
http://www.emergogroup.com/resources/china-process-chart

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.
India

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.
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.
Overview of regulatory process, 1 of 2
Appoint
agent
Complete
testing
Compile
application
Does your
device
require
registration?

28.
Overview of regulatory process, 2 of 2
Submit
application
Wait for
approval
Start
exporting!
Receive
certificate

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

34.
South Korea

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.
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.
Overview of regulatory process, 1 of 2
Classify
your device
Appoint
license holder
Meet KGMP
requirements
Submit
testing data

38.
Overview of regulatory process, 2 of 2
Prepare
submission
Submit
dossier
Wait for
approval
Start
exporting!

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

41.
https://emed.mfds.go.kr/#!CECAB01F010

42.
Questions? Please contact:
Evangeline Loh, Ph.D., RAC
Vice President, Global Regulatory
Affairs
evangeline@emergogroup.com
Thank you for your attention