s healthcare industry · registration renewal 0 5,000 10,000 15,000 20,000 top 10 provinces possess...
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Israel at a glance
CHINA’S HEALTHCARE INDUSTRY
Israel at a glance
CHINA’S HEALTHCARE INDUSTRY
Israel at a glance
15,698 registered manufacturers
181,809 distributors
135,762 products registered CFDA database
20% of the products undergo registration renewal
0
5,000
10,000
15,000
20,000
TOP 10 Provinces possess Domestic Medical Device Registration Certificate
JiangsuShanghai
Zhejiang
Guangdong
BeijingTianjin
ShandongHebei
Hubei
Henan
CHINA’S MEDICAL DEVICES SECTOR
28 33 40 48 57 70 86105
147
210237
275
354
413
472
567
0
100
200
300
400
500
600
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Sale Revenue Medical Device from 2001 to 2016 in China (Unit: 100 Million US Dollars)
Israel at a glance
CFDA – China Food and Drug Administration
CNCA -Certification & Accreditation
Administration
AQSIQ - General Administration of
Quality Supervision, Inspection and
Quarantine
SAIC - The State Administration Office for Industry and Commerce
SIPO - The State Intellectual Property Office
NHFPC - National Health & Family Planning
Commission
CMA – China Medical Association
DRC – Development & Reform Commission
KEY PLAYERS
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HOSPITALS IN CHINA
Public Private
Hospitals 13314 13000 51%-49%
Inpatients 123 Mil 16 Mil 90% - 10%
Outpatients 2.46 Bil 0.26 Bil 89%-11%
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Imported Medical Device Domestic Medical Device
License Holder Outside China In China
Actual
Manufacturing SiteOutside China
Except for innovative products, the license
holder must also perform the key
manufacturing processes, since CFDA does
not allow subcontract manufacturing for
domestic manufacturer.
Regulatory CFDA
Level
Class I: Central CFDA
Class II: Central CFDA
Class III: Central CFDA
Class I: City-level CFDA
Class II: Province-level CFDA
Class III: Central CFDA
Qualification needed
to sell the product in
China (Class II/III)
1. Registration and Quality management
system (QMS) certification in country of
origin
2. Have a China agent
3. Imported Product Registration
1.QMS Audit in compliance of Chinese good
manufacturing practice (GMP)
2. Domestic Product registration
3. Manufacturer License
Pros1. Good brand recognition
2. Higher margin as an imported device
1. Future reimbursement benefit
2. Lower manufacturing Cost
Con1. Stricter CFDA regulation
2. Higher cost for market entry
1. Higher in-country investment
2. Intercontinental management
IMPORTS VS DOMESTIC
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26% of registered products are
imported medical devices
REGISTRATION OF MEDICAL DEVICES
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THE NEW MEDICAL DEVICES CLASSIFICATION CATALOGUE
Revised
classification
criteria
Reduced the risk
level of 40
categories
Added more than
5,000 product
name examples
Adding clinical
indications and
product
description
Implemented: August 2018
• Before: Approved CFDA certificates will not be affected
• After: Extension process will be according to the new catalogue
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HEALTH INSURANCE IN CHINA
Basic Medical Insurance
Maternity Insurance
Critical Illnesses
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Certificate release1. 5 months
CFDA Second Review3 months
Reply to CFDA remarksOne year time and one chance only
CFDA First ReviewClass II at province-level, Class III at Central-level
Dossier submission and administration review5 working days
Clinical Evaluation Report / Clinical Trial in China
Registration test in a CFDA-qualified lab2-3 months excluding biocompatibility test
QMS Audit
Setup a WFOE or JV & OMS Establishment
Manufacturer License
Cheaper Fees
Local GMP
Cheaper Fees
Chinese entity
Cheaper manufacturing
DOMESTIC MANUFACTURING
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Innovative products Up to 50% shorter46 applied only 4
imported
Intellectual property
Pioneer in China
Premarket research and prototype
FAST TRACK
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Direct investment Government tender
DIRECT & GOVERNMENT PURCHASING
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Device Reimbursement
Distribution
Retail
PRE MARKET ISSUES
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Cancer
DISEASE TRENDS
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• In 2015 - 75.4 years
• In 2020 - 76.5 years (est)
Average life expectancy
•On January 1st 2016 the one child policy was formally abolished, allowing all couples to have 2 childrenOne child policy
2000 2050
DEMOGRAPHIC TRENDS
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THE CHINESE 5 YEARS PLAN
Series of social and economic development initiatives. In 2016 the government was released the 13th plan for the years 2016-2020.
Innovation
Balancing
Greening
Opening-up
Healthcare system
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THE CHINESE 5 YEARS PLAN
Chronic diseases Hygiene Education for health
Elders careSport facilities Women’s health
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Business Model under the “Two Vote System” for
Foreign Companies
Manufacturer
Agent
Distributor
Product licensing , Entrust
Dispatching Public
HospitalSale, Dispatching
Service
Provider
the First
Invoice
the Second
Invoice
the First
Invoice
①
②
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THE ISRAELI HEALTHCARE INITIATIVE
Israeli Know-How
Israeli Hospitals
Israeli Medical Experts
Israeli Technologies
Promoting selected programs which combine knowledge and devices.
Innovative IT Platform in Digital Health
Mobile Medical Training Simulations
Tele-Rehab Centers
Digital Health National Program
Emergency Properness
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CHINESE INVESTORS
Technology transfer
Money Transfer
Early Stage vs Mature
Companies
Manufacturers
Traded companies
Distributors
University Funds
Development base Economy
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Fast trackDirect &
government purchasing
Pre-market issues
Disease trendsDemographic
trendsThe 5 years
plan
The Israeli Healthcare Initiative
Domestic manufacturing
What investors look for?