Compliance & Product Regulatory ApproVals

From Mandatory registration to Licensing regime of class C & D non-notified medical devices

Class C & D non-notified medical devices which are currently in mandatory registration scheme will be notified under Licensing regime with effect from Oct 1st, 2023. In this regard, the concerned medical device officer will carry out the inspection within 60 days from the date of application.

Therefore, for hassle free registration under licensing regime, it is advisable for manufacturers or importers to start applying for the grant of registration with requisite documentations.

Here is the link of official notification https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAwMjI=

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Praveen Rao

CEO & Technical Director, C-PRAV Group: Australia, New Zealand, India & Canada 

C-PRAV Labs & Certifications 

Professional engineering experience of 30+ years with technical and managerial skills obtained from professional degree, courses, and hands-on experience, while working with organizations and companies involved in Design & Development, Testing, Inspection, Certification and Compliance (TICC). 

Management of electrical/electronic products & systems Testing and Certifications for Global markets in Consumer, Industrial, IT, Telecom, Defence, Medical, and Automotive Industries. Overall advisory for Standards, Regulations, Testing and Certifications for Global Market Access (GMA). 

  • ISO/IEC 17025 Lab Quality Management 
  • NATA Authorised Signatory (1995 to 2000) for EMC Testing 
  • NATA & IANZ Authorised Technical Assessor (current)
  • EMI/EMC, RF/Wireless, EMR-RF Exposure/SAR 
  • NATA Technical Assessors Advisory Committee (current) 
  • Current Chair of Australian EMC National Standards Committee 
  • Member of Australian National standards committees for Safety, Radio, RF Exp/SAR 
  • Represent Australia in International Standards committees like IEC, CISPR, IEEE 
  • Member of Telecommunications Certification Body Council, USA and European REDCA