DUBLIN, November 04, 2021– (COMMERCIAL THREAD)–The “Unique medical device audit program [MDSAP] Implementation and regulatory processes of participating countries: United States, Canada, Brazil, Australia and Japan “ training has been added to ResearchAndMarkets.com offer.
Global medical device regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements of your target markets will speed innovative products to market and help patients who need access to life-saving products and technologies.
Government regulatory authorities, who need to become more efficient with their time, are looking for ways to better use their internal resources without compromising the safety of products, which become marketable. One example is the one-time medical device audit program. [MDSAP], where authorized organizations would be allowed to perform a single GMP audit on medical device manufacturing facilities and support registrations in the current participating member countries: United States, Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all products licensed in Canada.
Why should you participate:
This 6 hours. The webinar focuses on understanding the unique medical device audit program, the scope of the program, how to apply, the authorized organizations, the rating system developed, and what you can expect when enrolling in the program. The webinar will discuss how these audits are organized, what to expect during an MDSAP audit, how it differs from a typical certified organization audit, as well as the movement of documents and documents. timing expectations for receipt of the institution’s certificate.
Highlights of key regulatory requirements for medical devices will also be covered for MDSAP participating countries: United States, Canada, Brazil, Australia and Japan.
- Introduction and review of the agenda
- Single Medical Device Audit Program (MDSAP): overview, history, audit process and report
- United States FDA – Overview of Medical Device Regulations and Regulatory Processes Across the Product Lifecycle
- Classification of devices, pathways of authorization, human factors and usability studies, GMP of medical devices, inspection process, labeling of devices, combination products, responsibilities of license holders
- Canada – Overview of Health Canada’s regulations and regulatory processes for medical devices throughout the product lifecycle
- Brazil – Overview of ANVISA medical device regulations and regulatory processes throughout the product lifecycle
- Australia – Overview of TGA medical device regulations and regulatory processes throughout the product lifecycle
- Japan – Overview of PMDA Medical Device Regulations and Regulatory Processes Throughout the Product Lifecycle
- Work effectively with national regulatory agencies
- Q&A session
For more information on this training, visit https://www.researchandmarkets.com/r/f5hasn
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