Registering a medical device in China requires a shift in mindset for US and EU manufacturers accustomed to FDA or EU MDR regulatory frameworks. The National Medical Products Administration (NMPA) operates under unique standards, processes, and timelines, making it essential to adapt strategies and practices to succeed in this rapidly growing market.
This workshop is tailored for US and EU or other manufacturers aiming to understand and navigate the complexities of Chinese medical device regulations effectively.
FDA:
EU MDR:
NMPA (China):
By the end of this workshop, participants will:
The workshop in onsite way is interactive after introduction of following basic knowledge. We will start generate trouble in field and find own solution in group work.
Introduction to the Chinese Regulatory Landscape
Key Regulatory Requirements in China
Preparing for Registration
Managing Challenges and Timelines
Post-Market Compliance and Continuous Improvement
This workshop is designed for:
Costs and duration vary based on:
Standard Format:
Why Join This Workshop?
This workshop equips US and EU manufacturers with the knowledge, tools, and strategies to transition smoothly from FDA/EU MDR frameworks to NMPA requirements. It bridges the gap between global and Chinese regulatory practices, empowering participants to achieve efficient and compliant market entry.
The most clients end our workshops with improved regulatory KPI in Chinese business up.
Dear Sir/Madam,
Thank you for contacting us.
We will answer you as soon as possible.
regards,
CEO
Antonio Lee
Easychinapprov
China, Germany
Frankfurt, Stuttgart Germany
Sun Dong An Plaza, No. 138
Beijing China
info@easychinapprov.com
0049-17638379004
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E-Learning "MyComplinace"
Learning Chinese regulation and global regulatory affairs
Participation possible any time.
Article:
International market of medical device for Startups,SME
Overseas inspecion starts again
Testing beyond and for registration
Significant changes of medical device in China, EU, MDSAP countries
Meet us in next conference:
Arab health in Dubai, 2025 Jan
Global compliance and training
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