Clinical Evaluation and Product Registration

At HTDK, our professional team possesses exceptional expertise in facilitating the entry of innovative global medical devices into the Chinese market. Determining device classification, assessing the need for local clinical trials, and navigating any expedited pathways pose challenges in terms of compliance and administrative complexities for global brands. HTDK offers a comprehensive range of services, including NMPA registration, clinical trials, and real-world data research, ensuring the compliant and successful market entry of products.

Set up customized pathway of registration, including local type-testing and submission dossier service.

Establish Clinical Evaluation Report, or conduct local clinical trials, to meet the clinical needs of registration in the most economical manner.

Act as your Local Agent, communicating with corresponding administrations.

When product design change happens after regulatory approval, assist to assess regulatory impact and set up proper regulatory plan.

When amendment or renew registration is mandatory per regulation, conduct corresponding registrations on behalf of oversea manufacturer.

Establish Off the Market strategy per minimized regulation requirements, write off registration license when necessary.