The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced.
Industry Executives and investors are complaining these days that their competitive edge is being jeopardized by the heightened regulatory scrutiny. For device companies based in the US, there is a growing trend in commercializing their products outside the country. In particular, many US-based companies are targeting new markets in the EU, China and, increasingly, India.
The process for approval or clearance of devices varies from regulatory body to regulatory body. In some cases, products achieve regulatory approval in an efficient and timely manner. In others, including the US FDA, companies may face a protracted and delayed approval process. Recent scrutiny by US regulators and legal authorities is making it more uncertain for companies attempting to gain market access in foreign countries.
In an economy where getting the jump on your competitors is so important, this training will provide a guide to ease international registrations and reduce time to market. Learning the relevant regulatory requirements and the appropriate document legalization path will speed up the pathway.
Areas Covered in the Session :
International regulation- Overview of country by country differences
Role and responsibilities of US manufacturers & in-country distributors
Identifying the key players
Working with in-country distributors
Sales forecasting – Who needs to know?
Types of documents need
Medical Device & IVDs
Best practices for document legalizations
Apostille vs. Authentications
How to get documents embassy legalized
Pitfalls – What to look out for.
Who Will Benefit:
Regulatory Affairs Specialists
Regulatory Affairs Managers
Teams involved in new product registration