The NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards revisions are to provide manufacturers on NMPA new regulatory thinking of type testing and registration submission.
These are recommended standards which are not legally binding but recommended by regulatory authorities.
- Cardiovascular implants: Vascular prostheses – Tubular vascular grafts and vascular patches
- Passive surgical implants: Specific requirements for breast implants
- Calibrator for blood analyzer
- Carcinoembryonic Antigen (CEA) Assay Kit
- Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic method)
- Human Leukocyte Antigen (HLA) Genotyping Test Kit
- Kit for determination of total bile acid
- Neurovascular implants Intracranial artery stents
- Blood gas analyzer
- In Vitro Diagnostic Test System Performance Evaluation Method Part 2: Accuracy
- Hepatitis B virus e antibody detection kit (luminescence immunoassay)
- Fetal chromosome aneuploidy trisomy 21, trisomy 18 and trisomy 13 detection kit (high-throughput sequencing method)
- Specific antinuclear antibody IgG detection kit (Western blotting)
- EB virus nucleic acid detection kit (fluorescence PCR method)
- Red blood cell and white blood cell count reference measurement procedure fixed value result measurement uncertainty evaluation guide
- Group B Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR Method)
- Anti-Mullerian hormone determination kit (chemiluminescence immunoassay)
- Treponema pallidum antibody detection kit (immunochromatographic method)
- Respiratory virus multiple nucleic acid detection kit
Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time. Contact us at info@ChinaMedDevice.com