AN INTRODUCTION TO MEDICAL DEVICE REGISTRATION IN CHINA

Ofer Ben ZviSinomedis LTd

oferb@sinomedis.comwww.sino-medis.com

12/12/2016

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

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

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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

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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

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Internal Structure & Organization Chart

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

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

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 listClass II and III that are not in the Clinical Trial Exemption list – but have a

substantial equivalent already registered in chinaClass 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

REGULATORY PROCESS INTRODUCTION

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Self Evaluation

Choosing a Local

Registrration Agent First

Documents Batch

PreperationWriting 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?

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.

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

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)

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.

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

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