Common FAQ

As per Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events, NMPA has regulatory requirements for Periodic Risk Evaluation Report (PRER) to enhance post-market surveillance.

The license holder shall:

• conduct continuous research on the safety of certified medical devices
• summarize and analyze the adverse event reports
• monitoring data and domestic and foreign risk information of the product
• evaluate the risks and benefits of the product
• record the risk control measures taken
• write the post-market Periodic Risk Evaluation Report (PRER)

PRER Report Contents:

1. Product information

• Name
• Certificate number
• License holder information
• Product model numbers
• Product composition
• Intended use
• Validity period

2.Global market approval information, for each country where the product is approved

• Listing status
• Date of market approval, first time to market, date of market withdrawal (if applicable)
• Model number approved in each country
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Initial registration submission dossier, Chapter 3 is for the Non-Clinical Research Material. In this chapter, the test report we submitted does not have to be performed or generated by the manufacturer itself. The manufacturer can engage an external lab to complete the test. There is no specific requirements for the qualification of the external lab. 

Examples of test: virological test, immunological test.

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The renewal submission must be submitted 6 month prior to the certificate expiration date. 

If the submission dossier is incomplete or the submission is not acceptable because of unapproved compulsory standard upgrade, the registrant will receive a pre-submission supplemental notice. Even though the submission is not officially accepted, the 6-month renewal deadline has been made.

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1. Re-issuance of registration certificate

(1). A registrant may, free of charge, apply for re-issuance of the registration certificate and/or its attachments and registration documents of the modifications within the valid period of the Medical Device/IVD Reagent Registration Certificate/registration documents of the modifications.

(2). Handling process

The registrant shall submit relevant application to the Administrative Service Hall of the National Medical Products Administration.

Application dossiers that meet the formal examination requirements will be accepted and then transferred to the Department of Medical Device Registration.

The staff of the Department of Medical Device Registration shall offer the examination opinions within 10 working days upon receiving the application dossiers, and the person-in-charge of the division will give his/her review opinions within 4 working days and feedback to the Administrative Service Hall.

The Administrative Service Hall will produce documents according to corresponding opinions within 10 working days, and perform service procedures as required.

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1. Definition of Supplementary

When the registration information can not meet relevant requirement or need additional information during evaluation, reviewers will issue a "Deficiency Letter" to the applicant collectively requesting the information needed at one time.

2. Way of Supplementary

(1). Online Mode

Issue the "Deficiency Letter" to the applicant/registrant through the eRPS system, mail the print edition of the "Deficiency Letter" at the same time.

(2). Offline Mode

Mail the printed "Deficiency Letter" to the applicant/registrant.

3. Requirement of Supplementary

Applicant/Registrant should complete the submission of the supplementary information within one year, according to the "Deficiency Letter" strictly.

4. Delivery

(1). Online Mode

Applicant/Registrant can submit the supplementary documents through “supplementary” module in eRPS system.

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1. Functions of the CMDE

Evaluation of domestic Class III and imported medical devices.

Administrative approval for change of licensing matters and registration renewal of domestic Class III and imported medical devices.

Approval decisions on clinical trials on Class III medical devices with high risks.

2. Registration Application Flowchart

3. Evaluation timeframe

90 working days for Class III medical devices.

60 working days for Class II medical devices.

One year for deficiency submission (excluded from evaluation timeframe).

60 working days for evaluation after response.

4. Query for evaluation and approval The progress of evaluation and approval can be queried via t

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1. A medical device registration certificate is valid for 5 years. According to national regulations, applicants/registrants shall apply for registration renewal no later than 6 months prior to the certificate expiry date. However, the registration renewal shall not be granted under any of the following circumstances:

(1). The applicants/registrant fails to submit the application within the prescribed time limit.

(2). The mandatory standards for medical devices have been revised, and the product fails to meet the new requirements.

(3). For medical devices required for the treatment of rare diseases or urgently needed to respond to public health emergencies, the items specified in the Medical Device Registration Certificate have not been completed within the prescribed time limit.

2. Handling process

(1). The certificate issuing authority is in charge of processing the applications for registration renewal.

(2). The Administrative Service Hall will transfer the application dossiers that pass formal examination to the Center for Medical Device Evaluation.

(3). The Center for Medical Device

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1.Rejected registration

(1). Interpretation on "Rejected Registration"

After the technical evaluation and/or administrative approval, the devices shall not be allowed for registration, if the application for registration of medical devices is deemed as unable to prove the safety, effectiveness or non-compliance with the requirements of laws and regulations.

(2). Common circumstances of rejected registration

Application dossiers for registration are false.

The contents of application dossiers for registration are disordered or confusing.

The contents of application dossiers for registration are obviously inconsistent with the application matters.

The project for registration application does not involve a medical device.

The applicant does not apply in accordance with the prescribed registration form.

The registration quality management system inspection result is that the medical device fails to pass verification after inspection or rectification.

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1. The benefits of priority review and approval

Getting priority for quality management system inspection.

Getting priority on the waiting list for evaluation and approval.

Getting special channel for communication.

2. Conditions for application

The National Medical Products Administration implements the priority evaluation and approval policy for registration of domestic medical devices of Class III and imported medical devices of Classes II and III which meet one of the following conditions:

(1). The medical devices which satisfy one of the following conditions:

The medical devices for diagnosis or treatment of rare diseases and with obvious clinical advantages.

The medical devices for diagnosis or treatment of malignant tumors and with obvious clinical advantages.

The medical devices for diagnosis or treatment of diseases which are endemic to and prevalent in the elderly and against which the existent diagnosis or treatment approaches have been ineffective.

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1. Notification on IFU Changes

For approved medical devices, Notification of IFU Changes refers to the process that the registration authority will, after the IFU is modified upon approval, notify the Department of Medical Device Registration, NMPA or provincial Medical Administration Department that the changes, excluding the content in the Medical Device Registration Certificate and its attachments are approved.

2. Three review results

Approve

Partially approve

Disapprove

3. Application procedures

Online(eRPS system):The applicant/registrant submits the application dossiers through eRPS system.

Offline: An applicant/registrant shall make an application to the National Medical Products Administration according to the requirements for application dossiers of Notification on IFU Changes.

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After the National Medical Products Administration makes a decision on approval, applicant/registrant shall receive their registration certificates for medical devices according to relevant regulations.

1. Query the progress of certificate production

Log in the website of National Medical Products Administration.

Click "Query for Comprehensive Administrative Licensing Matters".

Click "Query for The Schedule of Medical devices Registration".

The applicant/registrant can acquisition the certificate if the system displays "Completed - to be received”.

2. Ways of certificate claiming

(1). Way 1: On-site claiming

applicant/registrant can get their certificates at the  Administrative Service Hall of NMPA within 3 working days after the production of certificates is completed.

To claim the certificate, the agent shall provide his/her letter of authorization and the original and photocopy of his/her identity certificate.

Address：1 / f

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