Compliance & Product Regulatory ApproVals

Central Drugs Standard Control Organization (CDSCO)

Self-Certification of Class A Non-Sterile & Non-Measuring Medical Devices

CDSCO under the Ministry of Health And Family Welfare has recently issued notification to smoothen the licensing process for Class A (nonsterile and/or non-measuring) medical devices. Several manufacturers are waiting for the audit from the government licensing authorities. Online registration with self-declaration would make this
transition process easier. An online portal has been established under which the manufacturer must give the following information followed by allotment of Registration number in online portal.

  1. Name and address of the manufacturing site.
  2. Details of the medical device like generic
    name, brand name, intended use, material of construction, shelf life, etc.
  3. Undertaking
 

This Registration Number can be added to the label for sale in India. The applicant needs to maintain the records of manufacturing/ import along with its sales or distribution. The Licensing Authorities may verify the records, documents at any point of time and investigate quality or safety related failures or complaints.

Please click here to check complete notification

more insights

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