On September 28, 2021, NMPA issued a notice of five technical guidelines including Technical Guidelines for Clinical Evaluation of Medical Devices. The guidelines are the guidance for the applicants and reviewers. It doesn’t involves the administrative matters as review and approval for registration. Applicants should determine whether the contents are applicable based on the specific characteristics of the product. If not applicable, the reasons and corresponding scientific basis should be described in detail. Other methods complying with requirements of laws and regulations can also be adopted, but detailed research and verification data shall be provided.
Guidelines for medical device registration can be divided into:
Guidelines for technical review on medical device software registration;
Technical guidelines for clinical evaluation on medical devices;
Guidelines for technical review on medical device registration.
The guidelines usually include:
Scope of application,
Requirements for registration application dossiers,
Key review points,
Division of registration units,
Requirements for clinical evaluation,
Requirements for instructions for use.
The following are the guidelines issued by NMPA as of September 29, 2021, including 10 effective guidelines and 10 guideline drafts for comments.
No.
Guidelines Issued
Effective Date
1
Guidelines for Technical Review on the Comparison for Clinical Evaluation of Intravascular Catheters
September 2, 2021
2
Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents
September 16, 2021
3
Technical Guidelines for Clinical Evaluation of the In-vitro Diagnostic Reagents Exempt from Clinical Trial
September 18, 2021
4
Guidelines for Registration Review of Medical Device Animal Trial Study-Part 1: Principles for Decision Making (2021 Revision)
September 18, 2021
5
Guidelines for the Registration Review of Medical Device Animal Trial Study-Part 2: Quality Assurance for Trial Design and Implementation
September 18, 2021
6
Technical Guidelines for Clinical Evaluation of Medical Devices
September 18, 2021
7
Technical Guidelines for the Implementation of Medical Device Clinical Trials
September 18, 2021
8
Technical Guidelines for Demonstration of Equivalence in Clinical Evaluation of Medical Devices
September 18, 2021
9
Technical Guidelines for Clinical Evaluation Report for Registration Application of Medical Devices
September 18, 2021
10
Technical Guidelines for the Description of Comparison of Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation
September 18, 2021
No.
Guidelines (Draft for comments)
Deadline for comments submission
1
Guidelines for the Registration Review of Quality Uniformity of Additive Manufacturing Metal Implants (Draft)
October 8, 2021
2
Guidelines for the Preparation of Medical Device Technical Requirements for Registration Review (2021 Revision) (Draft)
October 8, 2021
3
Guidelines for Registration Review of Medical Device Clinical Trial Data Submission Requirements (Draft)
October 10, 2021
4
Guidelines for the Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drug-Device Combination Medical Devices (Draft)
October 15, 2021
5
Guidelines for Registration Review of Funnel Chest Forming System (Draft)
October 14, 2021
6
Guidelines for Registration Review of Ossicular Prosthesis (Draft)
October 15, 2021
7
Guidelines for the Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Equipment (Draft)
October 20, 2021
8
Guidelines for the Registration Review of Neurosurgical and Cardiovascular Surgical Devices – Knife, Scissors and Needles (Draft)
October 18, 2021
9
Guidelines for the Special Registration Review of the Digital Technology of Positron Emission Tomography/X-ray Computed Tomography System (Draft)
October 8, 2021
10
Guidelines for the Registration Review of Biosafety Cabinets (Draft)
October 11, 2021
Once the new guidelines are issued, all related registration applicants shall obey them. Therefore, special attention should be paid to whether their products meet the above principles when applying for registration. Brady has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us (info@inspirativemed.com) for more information.
