IVD——China and Global Registration Services

Reflected in policies and regulations, different countries have different risk classifications and review requirements for IVDs. The reform of the review and approval system for IVDs is deepening constantly in China. With the industry development, global promotion of products speeds up, and the need of global distribution of products increases continuously. As a global CRO, Tigermed-Jyton can provide regulatory support for China NMPA and global registration for the IVD products. Services related to product registration, covering various risk levels, including initial registration, changes, and certificate extensions: 1. Preparation of product technical requirements 2. Product registration testing / third-party testing 3. Preparation of product registration dossiers and pre-evaluation / third-party pre-evaluation 4. Evaluation process tracking, coordination and communication 5. Preparation and feedback of supplementary information