Common FAQ

1. Expert consultation meeting

Expert consultation meeting refers to the process in which the Center for Medical Device Evaluation of NMPA will invite consultancy experts (hereinafter referred to as “Experts”) to discuss the technical problems to be consulted and offer opinions during its evaluation work for medical device registration.

2. Circumstances in which an expert consultation meeting may be convened

The medical devices that have passed innovation approval.

The medical devices that have passed priority approval.

The medical devices that have passed expedited approval.

The medical devices that are firstly registered among the predicate products.

Technical subcommittees shall respectively resolve the technical problems of other products identified during evaluation. Disputes may be submitted to the Center's Technical Committee for discussion. When it is necessary to consult experts, the technical subcommittee may apply for convening an expert consultation meeting upon the approval of the Center's Technical Committee.

3. Relevant

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1. The Scope of Consultation after Supplementary

This consultation is mainly for medical device registration items that are in the state of being supplemented. Before the submission of supplementary documents, applicant/registrant can communicate with reviewer about questions of "Deficiency Letter".

2. Way of consultation

On-site consultation (every Thursday).

Online consultation (online Q&A in 20 working days).

Common questions on CMDE website.

Pre-evaluate for supplementary documents.

3. Reservation for consultation after supplementary

Log in the Technical Review Consulting Platform and click "Ordinary Product Consultation”.

Reserve "On-site Consultation” or "Online Consultation".

4. The process of Consultation after Supplementary

(1). On-site consultation

The on-site consultation shall be in principle scheduled at 9:00am

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1. Definitions

In case of any change to the Registration Certificate for Class II and III Medical Devices and its attachments, the applicant/registrant shall apply with the original registration authority for the change, and submit the registration dossiers.

2. Types of change

(1). Changes of permission items:

Changes in name and domicile of the applicant/registrant or agent in the registration certificate.

Production address change of domestic medical devices.

(2). Changes of registry items:

Change in the product name, model and specification indicated in the Registration Certificate and its attachments.

Change in the structure and components, scope of application and product technical requirements.

Production address change of imported medical devices.

Changes of corresponding content in the column "Other Content".

3. Handling process of registration changes

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1. Routes of Submission

Online: Applicants/registrant may submit  the electronic dossiers that meet the requirements of CMDE (Note: the filing of Class I Imported Medical Devices, Application for Re-issuance, Error Correction, Initiative Cancellation,Initiative Revocation of Registration Application and Medical Device Registration Designated Tests are not included in the business scope of eRPS system for the time being).

Offline: The paper dossiers can be submitted to the Administrative Service Hall either by post or on site.

2. When and Where

(1). Online

Upload and submit can be done anytime and anywhere through eRPS system.

(2). Offline

When: Working day(9:00am-11:30am;13:00pm-16:00pm).

Service Hall closed on Wednesday and Friday afternoons.

Where: Administrative Service Hall (1/F, Unit 3, Dacheng Plaza, No.28 Xuanwumen West Street, Xicheng District, Beijing).

3. Preparation

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1.The propose of Comparison with Predicate Medical Device

• Applicant/registrant can compare the subject product with one or more predicate medical devices to demonstrate that they are substantial equivalent (SE), according to the clinical trials or clinical application data of predicate medical device.

2.The significance and principle of Comparison with Predicate Medical Device

• The applicant/registrant shall prove that the subject product are SE to the products approved for domestic registered device in aspects such as basic principles, structure compositions, manufacturing materials, production process, performance requirements, safety evaluation, coincident national/industrial standards and intended use.
• At the same time, the applicant/registrant should prove the difference existing exerts no adverse effect on safety and effectiveness of products.

3.Content of Comparison with Predicate Medical Device

• Comparison Process
  1. Judgement: Comparison of subject product with predicate medical devices proves that they are SE.
  2. Data Collection
  3. Statistical Analysis of Data and Data Evaluation
  4. Clinical Evaluation Report: Following the completion of clinical evaluati

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1.Definition of Catalogue of Medical Devices Exempted from Clinical Trials

• For products listed in Catalogue of Medical Devices Exempted from Clinical Trials may be exempted from clinical trials. The Catalogue hereof covers Classes II and III products (including IVD reagents)

2.clinical evaluation data shall be prepared For the products listed in Catalogue

• Contrast data of subject product-related information to the contents described in Catalogue
• Comparison of subject product to the medical devices approved for domestic registration in Catalogue

Notes! Products, in case for the following conditions, cannot be exempted even when their names is in Catalogue

• Products that use new materials, new techniques, new active ingredients, new design or have new mechanism of action and new function
• Products with enlarged or changed scope of application
• Products whose performance indicators fail to meet standards listed in Catalogue
• Other situations that fail to meet clinical exemptions clearly listed in Catalogue

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1. Testing Object

The Classes II and III medical devices should do registered testing, but ClassⅠdo not need.

2. Preparation before Testing

Samples manufactured in compliant with the GMP.

Product technical requirements.

Products-related technical materials.

3. Select testing center

Principle: Registration testing shall be conducted in the testing center with medical device test qualification and capable of providing items for the product to be tested.

Choice Testing Center:

Visit CMDE's website and click the active bar at the bottom right which says“Test Directory of Test Center”. Enter the name of product or facility, and click “Search”.

Communicate with the testing facilities directly.

4. The Processes of Testing

The applicant/registrant signs a contract with the testing center.

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1. Introduction to Medical Device Classification

In China, medical devices are categorized into three regulatory classes based on the degree of risk level.

Class Ⅰ includes medical devices with the lowest risk, where safety and effectiveness can be ensured through routine administration. Only filing is required.

Class Ⅱ includes medical devices with moderate risk, where strict control and administration are required to ensure their safety and effectiveness. Registration is required.

Class Ⅲ includes medical devices with the highest risk and must be strictly controlled and administered through special measures in respect to safety and effectiveness. Registration is required.

2. Methods for Determining the Classification

1. Search Online

Visit the NMPA's website and go to the “医疗器械分类目录 (Classification Catalogue of Medical Devices)” search page.

2. Query Classification Rules/Catalogue

Directly query Rules for the Classification of Medical Devices or download Classification Catalogue of

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1.Scope of Pre-submission Consultation

“Full name” of pre-submission consultation is technical consultation about medical devices registration before application acceptance.

The scope of pre-submission consultation is primarily oriented toward technical issues before application for medical devices registration, excluding associated technical issues throughout the technical evaluation.

2.Application of Pre-submission Consultation

Time: Every Friday from 1:00 pm to 4:00 pm Address: Administrative Service Hall, Dacheng Square, Xuanwumen West Street, Xicheng District, Beijing

Domestic manufacturing enterprises should take the letter of authorization from the registration applicant that specifies the relevant matters entrusted, the valid personnel ID and Registration Form for Consultation of CMDE.

Overseas manufacturing enterprises should take the letter of authorization in which the overseas manufacturing enterprises designate the domestic enterprise legal person as agent, as well as one in which relevant entrusted contents are covered issued by the domestic agent, the valid personnel ID and Registration Form for Consultation of CMDE.

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The submission structure of registration application

Regional Administrative

• Submission Table of Contents
• List of Terms/Acronyms
• Application Form
• Listing of Device(s)
• Quality Management System, Full Quality System or Other Certificates
• Pre-Submission Correspondence and Previous Regulator Interactions
• Statements/Certifications/Declarations of Conformity
• Letters of Reference for Master Files
• Other Regional Administrative Information

Submission Context

• Chapter Table of Contents
• General Summary of Submission
• Device Description
• Indications for Use and/or Intended Use and Contraindications
• Global Market History
• Other Submission Context Information

Non-Clinical Evidence

• Chapter Table of Contents
• Risk Management
• Essential Principles (EP) Checklist
• Standards
• Non-clinical Studies
• Non-clinical Bibliography
• Expiration Period and Package Validation
• Other non-clinical Evidence

Clinical Evidence

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Laboratory comparison data for unauthorized predicates can be included as part of the CER. The success of CER pathway also depends on the adequacy of other data, such as previous clinical research data, literature data, etc.

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