The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval.
IVD Guidelines NMPA
- Guideline on Blood Glucose Monitoring System for Self-Testing
- Guideline on Tumor Marker Quantitative Detection Reagents
- Guideline on Influenza Virus Antigen Detection Reagents
- Guideline on Influenza Virus Nucleic Acid Detection Reagents
- Guideline on Pathogen-specific M-type Immunoglobulin Qualitative Detection Reagents
- Guideline on HBV DNA Quantitative Detection Reagents
- Guideline on Drug Abuse Detection Reagents
- Guideline on Gene Mutation Detection Reagents Related to Individualized Cancer Therapy
- Guideline on Toxoplasma, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus Antibody and G-type Immunoglobulin Antibody Affinity Detection Reagents
- Guideline on Instruction for Use of In Vitro Diagnostic Reagents
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
U.S. and European companies can be frustrated by China’s National Medical Products Administration (NMPA), a regulatory system that differs greatly from FDA, EU and other international markets. CMD focuses solely on China, so we can help companies overcome regulatory hurdles as well as significant language and cultural differences that can impact your business.
Our team has decades of clinical/technical experience, previously working for MedTech companies or in auditing roles with regulatory agencies. This deeper understanding of medical device development and how NMPA applies requirements in real life allows CMD to deliver clear guidance and practical solutions.