China NMPA Released the Draft Guidance for Tissue Engineered Medical Products for Public Comments

Your feedback counts!  China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers must follow.

To address the technical requirements during the application and further guide the registration review of tissue engineered medical products, NMPA’s Center for Medical Device Standardization Administration published the “quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method”, and “standard practice for evaluation of immune responses of substrate and scaffolds products: Lymphocyte proliferation test” for public comments. Any feedback needs to be submitted by October, 8, 2021.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.