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:
Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines.
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 |
Labelling 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
To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at sales@freyrsolutions.com
Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe.
InLumon's highly configurable software system delivered using our proven implementation approach, supported by an agile team eager to please our customers and empowered by the latest technologies.
We Overcome the issues using a proven framework supporting secure regulatory operations including Document Management, Workflows, Online Services, Audit trails, Interfaces and much more.
Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.
