Click here for this free interactive webinar on Wednesday, 30 June 2021.
Following a first successful webinar on the European regulatory requirements, ISS AG and its Asian partner, Qualtech Consulting Corp., joined again their forces to provide you with an insight into the registration of Medical Devices in China. We have designed a compact webinar addressing the New Regulation for Supervision & Administration of Medical Devices (RSAMD) and covering the following topics:
- NMPA’s measures supporting innovation, incl. simplified and priority review pathways and approval procedures, conditional approval pathway as well as measures encouraging the undertaking of clinical trials of innovative medical devices.
- New obligations for product registrants under the new nationwide adopted marketing authorization holder (“MAH”) system
- Risk and quality management: MAH’s responsibilities for the safety, quality, and efficacy of the MD throughout its entire life cycle
- Reform in clinical evaluation requirements and broader exemption from clinical evaluations
- Improvement of the supervision system and enhancing enforcement via an increase in penalties for committed violations
Feel free to share in advance any questions you might have on this topic via the registration form, or via info@iss-ag.ch.
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