The document provides an overview of medical device registration in China. It discusses the Chinese regulatory environment and key organizations like the China Food and Drug Administration (CFDA). The CFDA classifies medical devices and oversees the registration process, which involves choosing an agent, submitting documentation, conducting tests, making two submissions for review, and final administrative approval. Attention to small details and unpredictability are characteristics of the Chinese process.

1. AN INTRODUCTION TO
MEDICAL DEVICE
REGISTRATION IN
CHINA
Ofer Ben Zvi
Sinomedis LTd
oferb@sinomedis.com
www.sino-medis.com
12/12/2016

2. AGENDA
• China Medical device market –Brief introduction
• Characteristics of the Chinese regulatory environment
• CFDA –China Food and Drug Administrtion
• Classification of Medical device by CFDA
• Regulatory process introduction
• The do's and don't of china Registration
Ofer Ben Zvi
12/12/2016

3. CHINA MEDICAL DEVICE MARKET –BRIEF INTRODUCTION
• Global Medical Device market
• China Medical Market Size and Indices
• China Medical Market Composition
• China Medical Market Trends and Growth
Ofer Ben Zvi
12/12/2016

9. CHARACTERISTICS OF THE CHINESE REGULATORY ENVIRONMENT
Five main points characterize the Chinese Regulatory environment:
• The absent of transparency in regulations, guidelines and process
• The unofficial dimension of the process
• Constent change in the process and rules
• Importance and attention to small details
• Unpredictability regarding Length of the process and High Cost
Ofer Ben Zvi
12/12/2016

10. CFDA –CHINA FOOD AND DRUG ADMINISTRTION
Main Responsibility :
 Draft Laws, Regulation, Rules and Policy (regarding safety and
supervision of Food, Drug, Cosmetics and Medical Device).
 Formulation of Investigation and Enforcement of the Rules and
Regulations.
 Formulate the regulations on administrative licensing and
supervise their implementation.
 Organize the formulation and publication of medical device
standards and classification system; develop good practices on
research, production, distribution and use of medical devices;
undertake medical device registration, supervision and inspection;
establish monitoring system for adverse drug reactions, adverse
events of medical devices
Ofer Ben Zvi
12/12/2016

11. GeneralOfice
Comprehensive
Department
(OficeofPolicy
Research)
Departmentof
LegalAffairs Departmentof
MedicalDevice
Registration
DepartmentofFood
SafetySupervisionI Departmentof
Drugand
Cosmetics
Registration
(Departmentof
TCMsand
Ethno-
Medicines
Supervision)
DepartmentofFood
SafetySupervisionII
Departmentof
MedicalDevice
Supervision
Departmentof
Drugand
Cosmetics
Supervision
Departmentof
FoodSafety
SupervisionIII
Bureauof
Investigationand
Enforcement
Departmentof
Emergency
Management
Departmentof
Science,
Technologyand
Standards
Departmentof
Mediaand
Publicity
Departmentof
InternationalCooperation
(OficeofHongKong,
MacaoandTaiwan
Affairs)
Departmentof
Planningand
Finance
Departmentof
Human
Resources
Internal Structure & Organization Chart

12. DEPARTMENT OF MEDICAL DEVICE REGISTRATION
Department of
Medical Device
Registration
(Beijing)
Division of
General Affairs
Division of
Registration I
Division of
Registration II
Division of
Research
Supervision

13. CLASSIFICATION OF MEDICAL DEVICE BY CFDA
Finding out what class is your medical device according to the CFDA is
an important task, It will define the regulatory path as well as clear
some core issues such as :
• Registration cost
• Registration time
• Registration requirements
There are several sources to decide the right classification:
• CFDA Data Base (it is a public domain but currently available only
in Chinese)
• Comparison with similar deices that are already registered in china
• Consultation with your registration agent
• Open Consultation with CFDA technical review officer
Ofer Ben Zvi
12/12/2016
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14. REGISTRATION TYPES ACCORDING TO CFDA
CLASSIFICATION
• Initial registration for overseas medical devices that are approved for marketing at
abroad
• Initial registration for overseas Class I medical devices that are not approved for
marketing at abroad
• Initial registration for overseas Class II and III medical devices that are certified for
marketing at abroad
Class II and III that are in the Clinical Trial Exemption list
Class II and III that are not in the Clinical Trial Exemption list – but have a substantial
equivalent already registered in china
Class II and III that are not in the Clinical Trial Exemption list – and don’t have a
substantial equivalent already registered in china
• Renewal of registration for overseas medical devices
• Examination and approval for changes of overseas medical device registration
certificate

15. REGULATORY PROCESS INTRODUCTION
Ofer Ben Zvi
12/12/2016
Self Evaluation
Choosing a Local
Registrration Agent
First Documents
Batch Preperation
Writing the
"Product Standard"
Type Testing
Initial Submission
Second
Submission
Approval
Self Evaluation
consult and check the available resources to clear out the basic issue:
• Are there any limitations for registration in china of your device?
• What class is your Medical devices?
• What are the requirements for registration of your device in china?
• Do you have all necessary documentation?

16. Choosing Local Registration Agent
In order to register a device you need to have a local registration agent.
There are many registration agent in china, some great and some terrible,
better work with an agent that have good referance and experoance with
the same device registration.

17. First Documents Batch Preparation & Writing the
“Product Standard”
The Local registration agent will ask you to prepare and send the first batch of
documents :
• User Manual
• ISO13485
• CFS or Other marketing approval certificate
• IEC 60601-1, EMC report, Biocompatability report and any other standard
testing reports (as required from the nature of your device)
• Device picture, labels, packaging
• Device Spec
After receving the documents the Local agent will write a “Product standard” in
Chinese
This Phase takes usuually between 2 weeks – 1.5 month

18. Type Testing
Testing of your Device in a Local Chinese Testing Center:
• This Phase takes between 3-9 months (depends on the required testing)
• You will need to provide at list one device for testing (and sometimes also
samples of material)
• Usually all the standards need to be repeated for the registraion in china
• The testing must be done in a CFDA approved testing center
• The Testing must be done according to the Chinese Standard (GB)

19. Initial submission, Second submission & Administrative
approval
After completing the testing, receiving the test report and completing all required
document preparation you can try to submit to CFDA technical evaluation center:
• The CFDA Technical evaluation center reception officer will decide if your file is
complete and will accept the application.
• The relevant review officer will check and reply within 90 working days (Deny,
accept or ask for additional info).
• You will need to provide additional info within 1 year from the CFDA notice for
additional info.
• Second submission of additional info – will be processed within 60 working
days.
• In case the review office cannot decide he may ask to have an “expert comity”
appointed.
• Administrtive review and approval – within 60 working days from the technical
approval.

20. THE DO'S AND DON'T OF CHINA REGISTRATION
• Listen to your local agent
• Be prepared to the unexpected
• Importance of small detail
• Importnace of Harmony
• Don't argue with the regulator (or the testing center engineers)
• Don't try to save money in understanding the requirments
Ofer Ben Zvi
12/12/2016

21. Thank
You
谢谢
Ofer Ben Zvi
12/12/2016
Head of CFDA Yili,
ITGI CEO Aviv Lotan,
Sinomedis CEO Ofer Ben zvi
At the Israel Export Institute