China NMPA registration

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

Low Risk

Type of Certificate: Listing

On-counter submission

Class 2

Moderate Risk

Type of Certificate: Certificate

Online submission

Class 3

Follow CSDT Format

Type of Certificate: Certificate

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.

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