The NMPA IVD guidelines included five updates on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval.
For IVD Products
- Technical Review Guidelines for Genetic Deafness Related Mutation Detection Reagent
- Technical Review Guidelines for Cryptococcus Capsular Polysaccharide Antigen Detection Reagent
- Technical Review Guidelines for IgM/IgG Antibody Detection Reagent for Mycoplasma Pneumoniae
For Medical Devices
- Technical Review Guidelines for Predicate Clinical Evaluation of X-ray Computed Tomography Devices
- Technical Review Guidelines for Predicate Clinical Evaluation of Imaging Ultrasonic Diagnostic Devices
China Med Device suggest manufactures to follow the new requirements to do relevant registration. Surveillance for IVD products is becoming more and more stringent in China so CMD can help you evaluate the gap between China’s NMPA IVD guidelines or standards and those of your products.
About China Med Device
China Med Device, LLC, provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.