Overview

China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports. National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III). Class II and III devices require clinical data from NMPA accredited labs whose approval can take up to 2 years.

While aiming at Chinese market entry, applicants should ensure that the key documents are duly attached to get approvals within the review timelines. Some of the documents and review timelines include:

Get complete document list for China Get Timelines for approval in China

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines. With clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA. 

Freyr Expertise

Premarket Registration Support

  • Regulatory Strategy
    • Device Classification as per NMPA
    • Assess Clinical Trial Requirements and Exemptions or CER
    • In case of CER, Evaluation of Technical Clinical Information of a Predictive/Prototype CFDA Approved Device or Review of Existing Clinical Trial Tata Standards
    • Technical Document Preparation and Gap Analysis
    • Safety, Quality and Efficacy Assessment
  • Regulatory Submission and Approval
    • Compilation of Technical Documents and Registration Application
    • Dossier Translation
    • Clinical Testing Support and Management
    • Risk assessment, QMS Audit and Compliance
    • Self-assurance Statement Preparation
    • IFU and Draft Label Preparation and Translation
    • Labeling and Artwork Compliance
    • Local Agent Support, Attend Review Meetings
    • Liaison with HA until Approval
    • Import Permit and Custom Support

Clinical Trial Support and Management

  • Quality Maintenance
    • NMPA Audit Preparation
    • QMS Implementation and Monitoring Compliance
    • Standard Operating Procedure (SOP) Writing and Implementation
    • Quality Manual Writing
    • Ethics Standard Implementation and Monitoring
    • Ethical Review of Clinical Protocol
    • GxP Compliance
  • Clinical Trial Support
    • CRO Oversight and Management
    • Clinical Trial Application (CTA)
    • Pre-clinical Investigation of Medical Devices
    • Clinical Trial Protocol Design and Writing
    • Clinical Trial Auditing and Quality Assurance
    • Data Management and Statistical Analysis
    • Clinical Studies Report Writing

Post-Approval Regulatory Support

  • Post-Market Compliance
    • Monitoring and Reporting Adverse Events
    • Product Recall
    • HA Query Responses to Regulatory and Audits
    • Quality Management System (GMP and GSP compliance)
    • Review of Extrapolating Studies
    • Advertisement and Promotional Material Regulatory Compliance and Approval
    • License Renewals and Updates- Technical Document Review and Filing

Summary

S. No

Regulatory Parameter

China

1

Regulatory Authority

CFDA

2

Regulation

State Council Order No.650

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

Class I

Notification

Class II & III

Registration

5

Authorized Representative

China Agent required

6

Fee payable

Class I

No Fee

Class II

~ $34,000*

Class III

~ $ 48,000*

7

QMS Requirement

YY/T0287-2017

ISO 13485

8

Assessment of Technical Data

Center for Medical Device Evaluation (CMDE)

9

Validity of License

Class I

Unlimited

 

 

Class II & III

5 Years

10

Labeling Requirements

Decree No.6 of CFDA

11

Submission format

Paper

12

Final Outcome

Class I

Notification

 

 

Class II & III

Registration Certificate

13

Timelines

Class I

3 -6 months

 

 

Class II

1 - 2 years

 

 

Class III

More than 2 years

14

Language

English & Chinese

*The price is as per records at the time of documentation and is subject to change.

Process Flow

China Market Entry Strategy - Medical Devices Registration

To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at sales@freyrsolutions.com

 

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