Information for today’s Regulatory Professional
Welcome to RIMtelligence, a bi-weekly info-Blog that you’ll surely want to bookmark.
We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Authorised Representatives: Effective Collaboration Required
Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable for the marketing …
Continue reading “Authorised Representatives: Effective Collaboration Required”
26 May 2021 and the Burden of Mandatory Collaboration
Revenue Streams: Only as Strong as the Weakest Link
China – NMPA:396
What does your China regulatory strategy look like?
Internal Regulatory Intelligence
Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation.
Combination Products: MDR and Brexit
LinkedIn identifies 162 followers of #combinationproducts whereas the values for followers of #medicaldevice and #pharmaceuticals are 42 thousand and >1 million respectively.
