Information for today’s Regulatory Professional
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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 …
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?