China NMPA

China Medical Device Registration

Medical device sector is one of the fastest growing market sectors in China with the industry maintaining double-digit growth for over a decade.  Hence, it presents excellent opportunities for foreign exporters of medical equipment and supplies. Qualtech is your ideal partner to for your foray into the China medical device market for an easy and smooth registration process.

Qualtech in China

Pass Several GCP Inspections
China implements Good Clinical Practice from 2015. Qualtech has assisted many clinical sites to pass GCP inspection to ensure clinical performance.

Get Over 500 Approvals
Qualtech Beijing team is composed of 80% Master and PhD. With high-qualitied and experienced team, we assists clients to get China approval in efficiency!

QT Services
 
 

Medical Device Registration
With more than a decade’s experience in compiling successful NMPA (formerly CFDA) submission dossiers, our in-house experts are able to provide you excellent professional service in preparing customized dossier and complying with evaluators’ queries for medical device registration in China.

Clinical Trial and CER Writing
There are two options for clinical evidence to NMPA: Conducting clinical trial or submitting CER complied with China regulation. Qualtech has PhD leaded medical writing group, and an independent clinical trial team. Our experienced registration in medical device can ensure your clinical evidence meet NMPA’s requirement.

Local Agent
With changing and strict environment in China, it’s important to find a stable and professional local agent to assist you manage China market. Qualtech owns an excellent license holder system to support you easily manage the post-market surveillance, health insurance, regulation compliance, license renewal and other license-related works.

Product Testing
The NMPA requires in-country testing the Class II & III medical devices regarding China standards. Qualtech can provide a detailed assessment of the NMPA requirements for testing for your device and assist with registration.

Overview of Registration in China

The registration of medical device in China is a laborious process. The process is highly regulated by the China National Medical Product Administration (NMPA). In the process, firstly, the product technical requirement must be prepared. Following that, the product must be tested at any one of the NMPA - Accredited test centers with China GB/YY Standard or China Guidance. When the test report is obtained, the registrant shall do the clinical evaluation regarding China CER Guidance, if necessary, the registrant should conduct clinical trial in China. Once the clinical evaluation report (or clinical trial report) is presented, the product can be submitted for NMPA’s product registration.

The Center for Medical Device Evaluation (CMDE) is responsible for the technology review of every medical device. Once the device passes this stage, it moves on to the administrative review. Only when the NMPA reviewer is satisfied with the product’s submission and technical files, NMPA grants approval to the device’s official registration.

Classification
 
 

Class 1

 

Class 2

 

Class 3

Low Risk

 

Moderate Risk

 

High Risk

Type of Certificate: Listing 

  Type of Certificate: Certificate    Type of Certificate: Certificate

On-counter submission

 

Online submission

 

Online submission

 

 

TECHNICAL REQUIREMENTS
  CLASS 1 CLASS 2 CLASS 3
Device Summary

Yes

Yes

Essential Principles of Safety and Effectiveness

Yes

Yes

Predicate Product

Yes

Yes

Product Performance Report

Yes

Yes

Yes

Manufacturing information

Yes

Yes

Yes

Risk Assessment Report

Yes

Yes

Yes

Product  Technical Requirement

Yes

Yes

Yes

China Product Testing

Yes

Yes

Clinical Evidence

Yes

Yes

Yes

User Manual and Labeling

Yes

Yes

Yes

Note: Kindly see the No.4 Order issued in 2014 for more details. 

 

 

 
Workflow
 
 

NMPA Target Reviewing Turn-around Time
After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the NMPA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

Class 1 Listing
NMPA offers on-counter service for Class 1 listing, usually it takes 1 day to get Listing as long as you prepare sufficient files.

Class 2 and 3 Registration – Technical reviewing
NMPA divides into two stage: Technical reviewing and Administrative reviewing. The official turn around time of technical reviewing is 60 WDs and 90 WDs for Class 2 and Class 3, respectively. CMDE would give the deficiency letter to the registrant and go to compliance stage.

Class 2 and 3 Registration – Compliance
NMPA only gives the registrant one-time compliance with 1-year period. The registrant shall prepare all documents complied with NMPA’s requirement and submit on time.

Class 2 and 3 Registration – Administrative reviewing
CMDE would take 60 WDs to review the supplementary document from the registrants. If CMDE doesn’t have further question, the application would go to stage of Administrative reviewing in NMPA side, usually taking 20 WDs.

 

Validity
 
 
Types of Certificates: Listing, Certificate
Listing: Permanent
Certificate: 5 years

 

Tips
 
 

Should I Conduct Clinical Trial in China?
Many manufacturers have question on “Should I conduct clinical trial?” Actually NMPA offers two routes to prevent your product from clinical trial as below:

List of device exempted from clinical trial: NMPA would update this List in regular. If your product FULLY meet one item in the list, your product has opportunity to avoid clinical trial.

Clinical Evaluation Report: You can compare with predicate product based on China CER regulation and provide sufficient evidence. It’s important that the evidence shall be public or authorized by the manufacturer of predicate device.

NMPA can accept the oversea clinical trial report in degree. The registrant shall comprehensively explain the difference of China GCP and the GCP that oversea clinical trial complying with.

For more information, please refer to the NMPA’s official website at NMPA Website or you may contact us for a free consultation.  

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Official Website
 
 

NMPA Website Homepage
NMPA Product Database
NMPA Regulatory Announcement Board

CMDE Product Guidance Database

Recommendation
 
 
★ [ANALYSIS] CHINA Medical Device Market Overview and Importation Process
NMPA Published the Update Guidance of Adverse Event Monitoring for Medical Device
NMPA Publishes Draft Amendment of the Regulations for the Supervision and Administration of Medical Devices