Medical Devices & IVDs

The medical device industry encompasses a wide variety of products including In Vitro Diagnostics. The Medicines Control Council has issued 5 guidelines that relate to the regulations published on 9 December 2016 and qualify the compliance expectations.

A Gazette calling for licensing of companies involved in the sale, import, export, manufacture, distribution, warehousing, wholesaling, commissioning, etc.,  was published on 24.02.2017. The deadline for licensing of companies involved with any of these activities is 23.08.2017, excepting wholesalers who have until 23.02.2017 to submit their applications for licensing.

We can assist with the following:

  • Product classifications
  • Creation of Site Master Files
  • Design and Implementation of Quality Management Systems
  • Development and Implementation of Standard Operating Procedures
  • Collation of Standard Technical Documents
  • Review of Labels and IFUs


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