Information for today’s Regulatory Professional

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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.

Class I MDR Compliance

The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices

Importers – Strategic Partners

Medical device manufacturers must provide regulatory teams with the tools and resources to ensure compliant interactions with their supply chain partners.

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 …

China – NMPA:396

What does your China regulatory strategy look like?