NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing and make guidelines more consistent with the international counterparts.
Importance of Device Guideline
The guidelines are prepared by the NMPA’s Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by the NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
Guidelines to Revise
The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. The revisions include but not limited to the following:
- Guiding Principles for Writing Registration Application Documents for Drug-Containing Medical Device Products
- Technical guidelines for clinical trials of in vitro diagnostic reagents
- Guidelines for the preparation of instructions for in vitro diagnostic reagents
- Guidelines for the preparation of technical requirements for medical device products
- Guidelines for Technical Review of Virus Inactivation Process Verification for Allogeneic Implantable Medical Devices
- Guidelines for technical review of in vitro diagnostic reagent analysis performance evaluation (accuracy-methodological comparison)
- In Vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy-Recovery Test) Technical Review Guidelines
- Guiding Principles for Registration and Application of Passive Implantable Medical Device Products
Guidelines by Devices
- Guideline for technical review of gastric tube product registration
- Guideline for technical review of endotracheal intubation product registration
- Guiding Principles for Registration and Application of Blood Glucose Monitoring System for Self-Test
- Guideline for the technical review of breast implant product registration
- Guideline for technical review of registration of contact lens care products
- Guideline for technical review of product registration for single-use infusion devices
- Guiding Principles for Registration and Application of Tumor Marker Quantitative Detection Reagents
- Guideline for writing instructions for rigid air-permeable contact lenses for orthokeratology
- Guideline for technical review of registration of disposable surgical gown products
- Guideline for the technical review of registration of natural rubber latex condoms
- Guideline for technical review of registration of single-use vacuum blood collection tube products
- Guiding Principles for Registration and Application of Influenza Virus Antigen Detection Reagents
- Guiding Principles for Registration and Application of Influenza Virus Nucleic Acid Detection Reagents
- Guideline for Technical Review of Surgical Power Equipment Product Registration
- Guideline for technical review of registration of breathing circuit products for anesthesia machines and ventilators
- … …
For the compete list of guidelines revisions, please email info@ChinaMedDevice.com.