Taking Medical Devices to Market in China | NMPA Registration & Localization

Expanding medical device and IVD businesses into China presents major regulatory, linguistic, and cultural challenges. In this expert webinar, Seprotec and Cisema explore the key requirements for entering the Chinese healthcare market, including NMPA registration, compliance pathways, cybersecurity requirements, localization best practices, and effective communication strategies for China. Industry experts Hamish King and Victoria Caldy from Cisema, Shirley Yeng, Linguistic Consultant, and Rocío Fernández Huertas from Seprotec share practical insights into China’s regulatory framework for medical devices and in vitro diagnostics (IVDs), including risk classification, approval processes, software compliance, and the importance of culturally accurate localization. Key topics covered include: China NMPA registration requirements for medical devices and IVDs Regulatory pathways and approval processes in China Risk classification and cybersecurity requirements Medical device software compliance Localization and Chinese language best practices Cultural considerations for market entry and communication Translation and multilingual quality management for life sciences companies This webinar is ideal for professionals in medical devices, life sciences, regulatory affairs, compliance, localization, international expansion, and healthcare market access who are considering entering the Chinese market. Learn more about Seprotec’s life sciences and medical translation solutions: https://seprotec.com/ Follow Seprotec for more industry webinars and insights:   / seprotec-multilingual-solutions   #MedicalDevices #NMPA #ChinaMarketAccess #LifeSciences #MedicalTranslation #Localization #RegulatoryAffairs #Seprotec