Medical Devices | non-IVDs & IVDs

The medical device industry encompasses a wide variety of products including In Vitro Diagnostics. The Medicines Control Council has issued several 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 the submission of the establishment licenses was 23.08.2017, excepting wholesalers who have until 23.02.2017 to submit their applications for licensing.

The registration forms, based on the IMDRF content requirements and naming, have been published for comment by the MCC. It is expected that registration call-ups for medical devices will commence in the first half of 2018.

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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