Service & Tech

IVD Reagents
Domestic and Foreign Registration and Filing

Reflected in laws and regulations, different countries have different risk classifications and review requirements for medical devices. The reform of the review and approval system for medical devices 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 can provide regulatory support for domestic and foreign launching of products.

•  The domestic agent of imported products

•  Foreign application for exported products (CE, FDA)

•  NMPA application for imported products

•   NMPA and competent local authority application for domestic products

Product registration and filing (first application, change and renewal of products with different risk levels)

•  Preparation of product technical requirements

•  Product registration testing/third-party testing

•  Preparation and preliminary review / third-party preliminary review of product registration materials

•  Review process tracking, coordination and communication

•  Preparation of supplementary materials and feedback

•  Prioritized review application tracking