Your Feedback Counts! Contribute Your Wisdom To Guideline For Neurosurgical And Cardiovascular Surgical Devices
2021-09-23
On September 2, 2021, Guideline for Registration Review of Neurosurgical and Cardiovascular Surgical Devices – Knife, Scissors and Needles (Draft) drafted by CMDE of NMPA was released to solicit comments, which aims to help and guide the registration applicants to prepare the application dossiers to meet the standards of technical review. Any feedback needs to be submitted by October 18, 2021.
Contents of the Guideline (Draft)
Scope of Application
The Guideline is applicable to the scalpels, scissors and needles of non-active neurosurgical and cardiovascular surgical devices in Class II.
Division of Registration Units
According to the scope of application of such surgical devices, it is recommended that neurosurgical devices and cardiovascular surgical devices should be classified into different registration units. Similar surgical devices with the same scope of application can be classified into the same registration unit.
Requirements for Registration Application Dossiers
(I) Summary data 1. Overview (management category; product name) 2. Product description 3. Model and specification 4. Packaging instructions 5. Scope of application and contraindications 6. The situation of the predicates or predecessors referred to
(II) Study data 1. Product performance study (1) Hardness (2) Surface roughness (3) Corrosion resistance (4) Connection firmness (needle body and needle handle, blade and handle, etc.) (5) Service performance (such as blade edge sharpness, blade and handle insertion/disassembly ease test, blade elasticity, shearing performance of surgical scissors, toughness of surgical needle tube, etc.) (6) Chemical composition of materials (7) Ethylene oxide residue (applicable to the products sterilized by ethylene oxide) (8) Sterile (applicable to the product delivered in sterile state) (9) Bacterial endotoxin (applicable to the product delivered in sterile state) 2. Bio-compatibility evaluation study 3. Sterilization process study 4. Product shelf life and packaging research
(III) Product technical requirements 1. Description of product model/specification and classification 2. Performance indicators 3. Test methods 4. Others
(IV) Type testing report
(V) Instruction for use and label
It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.
