Analysis of the entire process of medical device registration agency and common problem answers

1、 The core steps of medical device registration agency

1. Product classification and regulatory confirmation

Firstly, it is necessary to clarify the classification level of medical devices (Class I, II, or III), and different levels correspond to different registration requirements. The agency will assist clients in confirming the applicable regulatory standards for the product, including relevant regulations of the National Medical Products Administration (NMPA).


2. Technical document preparation

This is the most crucial step in the registration process, including:

Product Technical Requirements Document

Risk Management Document

Clinical evaluation report (or clinical trial data)

Product manual and label

Production process documents

Quality Management System Documents




3. Sample testing

Send the product to a testing institution recognized by NMPA for testing and obtain a testing report that meets national standard requirements.




4. Submit registration application

Organize the complete registration application materials and submit them to the provincial or national drug regulatory authorities through the electronic application system for medical device registration.




5. Technical review and supplementary materials

The drug regulatory department conducts technical review on the submitted materials, and may require additional information or explanations during the process. The agency needs to respond to these requirements in a timely manner.




6. On site verification

For Class II and III medical devices, drug regulatory authorities usually conduct quality system inspections at the production site.




7. Approval and issuance of certificates

After passing all review processes, the drug regulatory department will issue a medical device registration certificate and the product will obtain marketing authorization.




2、 Frequently Asked Questions and Answers

Q1: How long does it usually take for medical device registration?

A1: The registration period varies depending on the product category:

Class I medical devices: usually 1-3 months

Class II medical devices: 6-12 months

Class III medical devices: 12-24 months

The actual time also depends on the preparation of materials, the progress of review, and the response speed of supplementary materials.




Q2: What are the differences between the registration of imported medical devices and domestic ones?

A2: The main difference lies in:

Imported products require a certificate of listing from the country of origin

Need an agent within China

Some documents require notarization and authentication

Instructions and labels need to be in both Chinese and English




Q3: How long is the validity period of the registration certificate? How to continue?

A3: The validity period of the medical device registration certificate is 5 years. Extension registration should be applied for 6 months before the expiration of the validity period, and materials such as extension registration application, product no change statement, and quality management system operation status should be submitted.




Q4: What is the most common reason for rejection during the registration process?

A4: Common reasons for rejection include:

Incomplete or non-standard technical documents

Insufficient clinical evaluation data

Inadequate risk management

The test report does not meet the requirements

Defects exist in the production quality management system




Q5: How to choose a reliable registration agency?

A5: It is recommended to investigate the following aspects:

Do you have relevant qualifications for medical device registration

Number and types of successful cases

Professional team's experience and background

Communication channels with regulatory authorities

Is the service content and charging standards transparent




Q6: What else should be noted after product registration?

A6: After registration, please note:

Regularly submit adverse event monitoring reports

Significant changes require change registration

Accept daily supervision and inspection by the drug regulatory department

Maintain the effective operation of the quality management system

Pay attention to regulatory updates to ensure continuous compliance




Through professional registration agency services, enterprises can complete the medical device registration process more efficiently, avoid common errors, and accelerate the product launch process. Choosing an experienced agency can significantly improve registration success rates and reduce compliance risks.