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mHealth Israel_MedTech and Digital Health China Regulatory_Physio Logic_Feb 2016
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
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
----- Meeting Notes (14/02/16 12:37) -----
As both health care industry and the digital envirenment in china are growign and evolving it is crucial to understand the rules
----- Meeting Notes (14/02/16 12:37) -----
China is No. 2 biggest medical device market in the world
As well as the first in internet and mobile use and addoption
----- Meeting Notes (14/02/16 12:34) -----
The process