mHealth Israel presentation by Ofer Ben Zvi, Physio-Logic, about China MedTech and Digital Health Regulatory Issues.

1. "MedTech and Digital Health
Regulatory Environment in
China"
16.02.2016
Ofer Ben-Zvi

2. • CFDA Regulatory process Introduction
• Regulatory issues influencing the Digital health
application in china
• Physio-Logic’s solution and added value

3. Ofer Ben Zvi– Been There And Done That
 15 Years of Experience in the Chinese market
 8 years of experience in medical device industry
 Served as COO Syneron China
 Served as Head of Ischam china healthcare industry
committee
 Serve as CEO of Sinomedis Ltd.
 Practical experience in Medical Device registration
in China
Ofer Ben Zvi
Cell: 0523-159-769
ofer@physio-logic.co.il

4. China Medical Market Trends and Growth

5. Medical Device Regulatory Process
Introduction
1. Self Evaluation
2. Choosing a Local
Registration Agent
3. First Documents Batch
Preparation and writing the
Product standard
4. Type Testing
5. Initial Submission
6. Second Submission
7. Expert committee
8. Administrative Approval
Phase I &
II
Phase IV,
V & VII
Phase X
Phase III
Phase VIII
& IX
With Customer
representative led by Physio-
Logic

6. Regulatory Requirements for
Digital Medical Application
• All SW that are registered are classified as
the highest classification of the device the
are used with/for.
• Basically Health Apps in China don’t need
to go through registration.
• A Trend of an increasingly favorable
regulatory environment.

7. Recommendations for Digital
Medical Application registration
• If you are not sure it is always best to
have a dialogue with the CFDA.
• Best solution is to partner with the
big players as they have good
access to the regulator.

8. Full Service Solution for Medical Device Manufacturers
• Twenty five (25) Subject Matter Expert:
• Approved vendor of the top 5 International Medical Device
companies
• Vendor of choice for start-ups and serial entrepreneurs
• IVD team
• Digital Health team
 Usability
 FDA 513(g), 510(k), PMA
 CE Mark
 ISO13485, ISO9001, CMDCAS
 CLIA
 International registration
including Russia and China
 Compliance
 HW & SwQA
 Design Control
 Risk
Management
 Performance
evaluation
 Clinical
evaluation
 HIPPA
 Cybersecurity

9. Our Solution and Added
Value
Cutting Time To Market By:
 Eliminating delays and miscommunication with CFDA
and third parties resulting from cultural difference
 Relying on credible third party providers
 Constantly tracking the regulatory changes and
responding in a timely manner
 Reducing client overhead in managing the process

10. www.physio-logic.co.il
Ofer ben zvi- China Registration manager
ofer@physio-logic.co.il
Cell: 0523-159-769