Approval in China – Tailor-made solutions for the Chinese healthcare market
The National Medical Products Administration (NMPA) is the central regulatory authority in China. It monitors the safety, efficacy, and quality of drugs, medical devices, and other healthcare products. Compliance with NMPA requirements is crucial for companies wishing to enter the Chinese market. Our specialized experts provide comprehensive support in the development and implementation of customized compliance strategies. We offer the following services:
- Regulatory consulting & strategy development: We analyze the relevant NMPA regulations and adapt your processes accordingly to ensure that you meet all requirements.
- Documentation & technical file preparation: Preparation and translation of all necessary documents in accordance with NMPA guidelines.
- Quality and risk management: Optimization of your quality management system and implementation of preventive measures to ensure the highest safety standards.
- Audit preparation & communication with authorities: Comprehensive support during inspections and ongoing assistance throughout the entire approval process.
Take advantage of our expertise to ensure regulatory compliance for your products and establish them on the Chinese market for the long term.