FAQ

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.Clinical Evaluation

Medical device clinical evaluation refers to the process in which the applicant validates whether the products meet use requirements or scope of application through information such as clinical literature, clinical experience data and clinical trials.

All medical device need Clinical Evaluation, but requirements for clinical evaluation data may be different fueled by varied application scope of medical device leading to various risks throughout the use.

2.Types of Clinical Evaluation

For Products listed in Catalogue of Medical Devices Exempted from Clinical Trials (hereinafter referred to as new Exemption Catalogue), applicant/registrant should submitted two part of clinical evaluation data.

√ One part is contrast data of subject product-related information to the contents described in Exemption Catalogue.

√ The other part is Explanation on comparison of subject product to the medical devices approved for domestic registration in Exemption Catalogue

Though comparison with predicate medical device: Applicant/registrant should compare the subject product with one or m

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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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As per NMPA CMDE Department 4, the matching between metal powder and printing parameters involves the manufacturing process of powder and the key process parameters of printing equipment. For the manufacturing process, the key process principles and selection basis (such as electrode induction melting gas atomization, plasma inert gas atomization, vacuum induction melting gas atomization, plasma rotating electrode atomization, etc.) shall be submitted, and the key process parameters shall be submitted (such as gas pressure, flow rate and temperature, inner diameter and injection angle of atomization nozzle, pressure and oxygen content in atomization tower, current and speed of rotary electrode atomization process, etc.), and submit relevant research V&V data. For the matching with the key process parameters of printing equipment, it should consider the process parameters such as laser power, spot diameter, scanning speed, scanning spacing, powder laying thickness, printing direction, atmosphere protection, support structure, forming chamber temperature, and submit relevant research V&V data.

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As per NMPA CMDE Department 2, when using overseas clinical trial data for registration in China, the applicant should submit the EC opinions (such as EC approval letter) from overseas clinical trial institutions, clinical trial protocol and clinical trial report. The form, content, signature and seal of these documents shall meet the relevant requirements of clinical trial quality management in the country (region) where the overseas clinical trial is conducted. In addition, the applicant should also submit a gap analysis report on the factors related to domestic and overseas clinical trials, detailing the such gaps and the relevant treatment measures. If necessary, relevant laws, regulations, specifications or standards related to clinical trial quality management in the country (region) where the overseas clinical trial is conducted should also be submitted.

The applicant should provide complete overseas clinical trial data without screening. The overseas clinical trial report should include the analysis and conclusion of the complete clinical trial data.

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As per NMPA CMDE Department 1, for the patient monitor and other active medical devices containing more accessories in direct/indirect contact with human body, in the aspect of biocompatibility evaluation in the process of potential biological risk management, it is suggested that the biological evaluation of accessories should be divided into the following three cases:

1. In case of exemption from biocompatibility evaluation, it is recommended to issue a statement with reference to CFDA [2007] No. 345, describing no circumstances occurring specified in Article 4 (1):
   Article 4 (1) The manufacturer shall consider re-evaluation of biosafety under the following circumstances:
   a. Changes in the sources of materials or technical conditions used to manufacture products;
   b. Changes in product formula, process, primary packaging or sterilization;
   c. Changes in the final product during the storage period;
   d. Changes in the use of the product;
   e. When there are indications that the product will produce adverse reactions when used in human body.
2. In case of biocompatibility evaluation, it is recommended to select and evaluate the accessories according to the biological evaluation procedure in the risk management process shown in the systematic approach diagram in GB / T 16886.1-2011.
3. In case of biocompatibility test, it is recommended to identify the data or test

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