On April 9, the TC94 (National Technical Committee for Standardization of Surgical Instruments) has announced the completion of its draft for the general requirements and test method for surgical instruments – non-cutting, articulated instruments. The TC94 is currently soliciting public comments until June 10, 2021.
On April 12, the NMPA (National Medical Products Administration) issued (No.25.2-2021) a report for conducting sampling inspection on 9 product categories covering electric wheelchairs, soft contact lenses, and disposable nasal oxygen cannula.
The following 55 products did not meet the standard requirements:
- 15 electric wheelchairs
- 7 soft contact lenses
- 1 electrical nerve and muscle stimulation machine
- 6 infusion pumps
- 1 optometry examination equipment
- 5 disposable nasal oxygen cannulas
- 7 medical electronic thermometers
- 8 medical oxygen concentrators
- 5 medium frequency electrotherapy equipment
On April 15, the NMPA issued (No. 24 – 2021) the technical guidelines for the registration of 5 medical devices:
- Technical Guidelines for the Registration of Tumor Companion Diagnostic Reagents Based on Similar Therapeutic Drugs
- Technical Guidelines for the Registration of Real-time Fluorescent PCR Analyzer
- Technical Guidelines for the Registration of Rotavirus Antigen Detection Reagents
- Technical Guidelines for the Registration of Group B Streptococcus Nucleic Acid Detection Reagents, and
- Technical Guidelines for the Registration of Human Parvovirus B19 IgM/IgG Antibody Detection Reagents
The CMDE (Centre for Medical Device Evaluation) of the NMPA announced their plans to formulate the following technical guidelines for:
- The clinical evaluation of gene sequencers (Announced on April 12, 2021)
- The survival of motor neurons Gene 1 (SMN1 gene) testing reagent (Announced on April 12, 2021)
- The design of clinical reproducibility studies of PD-L1 detection reagents (Announced on April 12, 2021)
- The microsatellite instability (MSI) detection reagents for clinical trials (Announced on April 12, 2021)
- The registration application materials for quality control test reagents (Announced on April 14, 2021)
- The performance evaluation of Human Immunodeficiency Virus Antigen and Antibody Detection Reagents (Announced on April 15, 2021)
The CMDE is also asking for the public input from manufacturers and related companies to support the writing of the above-mentioned technical guidelines.
By Jacky Li. Contact Cisema if you would like to learn more.
