Global Medical Device Registration: Impact of Changes to the EU MDR and Chinese GCP on Manufacturers
1 hour Video | Gert Bos and Xiaoli Gou, Qserve Group
Medical device safety and efficacy is a top priority for manufacturers, healthcare providers and regulators around the globe. The European Union recently passed updated regulations for medical device and in-vitro diagnostics, while the China Food and Drug Administration (CFDA) has enacted “The Good Clinical Practices for Medical Device Clinical Trials”. The EU requirements define clear responsibilities for manufacturers to track the quality and capability of devices, while the changes in China represent an ongoing initiative to have greater alignment with EU device regulations. Both developments represent landmark legislation intended to protect the rights of patients while demonstrating devices are supported by accurate data. This will ultimately affect all manufacturers looking to register products in Europe and China, as regulatory teams will need to develop an inclusive global strategy to ensure success.
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Global Regulatory Submissions
Executive Director and Partner
Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession over the last 15 years he has been awarded as Fellow of RAPS.
Ms. Xiaoli Gou is Qserve’s expert on Chinese medical device regulations. She studied in Singapore and in the Netherlands, where she graduated in Biomedical Engineering (BSc) and in Management in Health (MSc). In the multi-national regulatory compliance projects that she supports, she skillfully combines knowledge and expertise from different fields and providing pragmatic solutions. She authors whitepapers and blogs on the Chinese CFDA regulatory requirements.