10 Apr Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments
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This is intended to provide stakeholders with guidance and the requirements for medical device (including In Vitro Diagnostics (IVDs)) manufacturers, distributors and wholesalers who appoint or contract a third party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose of placing the product on the market under the establishment’s name.
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Document Number:
MD02-2026/27
Version:
1
Date Updated:
10/04/2026
File Type:
www
Category:
Communication to industry