中國NMPA註冊

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 team is composed of 80% Master and PhD. With high-qualified 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 with 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 clinical evaluation report (CER) complied with China regulation. Qualtech has PhD-led 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 help 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 which include official or accredited third-party laboratories with China GB/YY Standard or China Guidance. When the test report is obtained, the registrant shall evaluate whether the subject device is listed in Exemption from Clinical Evaluation Medical Devices. If yes, the registrant shall do the SE comparison regarding China Guidance of Comparison Description for Products in Exemption List. Otherwise, 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 approval. 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
 
 

 

 

TECHNICAL REQUIREMENTS
  CLASS I CLASS II CLASS III
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

Product  Technical Requirement

Yes

Yes

Yes

China Product Testing

Yes

Yes

Clinical Evidence

 

Yes

Yes

User Manual and Labeling

Yes

Yes

Yes

Note: Kindly see the No.47 Order issued in 2021 for more details. 

 

 

 
Workflow
 
 

NMPA Target Reviewing Evaluation 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 evaluation times for different types of transactions involving product registration/notification.

 

 

Validity
 
 
Types of Certificates: Listing, Certificate
Listing: Permanent
Certificate: 5 years
Tips
 
 
Should I Conduct Clinical Trial in China?

Many manufacturers have the question “Should I conduct clinical trial?” Actually NMPA offers two routes to prevent your product from clinical trial as below:

List of devices exempted from clinical evaluation: NMPA has updated this Notification No.33, 2023. If your product FULLY meet one item in the list, your product has opportunity to avoid submitting clinical evaluation report, but only submit SE comparison with NMPA approved similar product.

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 Published Decree No. 739 the Regulations for the Supervision and Administration of Medical Devices