Home India Ministry of Health and Family Welfare Public Notice for feedback on Medical Device Online Portal...
Date: 2018-12-05 Category: Not Applicable State: Union Government Country: India

Public Notice for feedback on Medical Device Online Portal

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The Central Drugs Standard Control Organisation (CDSCO) is seeking feedback from stakeholders to improve its online Medical Device portal (www.cdscomdonline.gov.in).
  • This initiative aligns with the Government of India's Digital India and Ease of Doing Business initiatives.

Key Changes

  • CDSCO has rolled out online services for application filing through the SUGAM portal since 2016, including services for Import & Registration, Cosmetics, GCT, Biological divisions, and others.
  • A separate online portal specifically for Medical Devices and IVDs has been launched in accordance with the new Medical Device Rules 2017.
  • The notice requests stakeholders to provide feedback on the Medical Device online portal using a provided feedback form (Annex-I).
  • Feedback should include suggestions for short-term, medium-term, and long-term improvements.
  • The deadline for submitting feedback to feedback@cdsco.nic.in is within 2 weeks of the notice publication, in both scanned PDF and Excel formats.

Impact Analysis

Medical Device and IVD Manufacturers

  • Action Items: Medical Device and IVD Manufacturing Associations should consolidate feedback from their members and submit a comprehensive response to CDSCO by the deadline. Individual manufacturers should contribute to their association's feedback.

CDSCO

  • CDSCO should communicate the changes made to the portal based on the feedback to the stakeholders.

General Public

  • Impact: An improved Medical Device online portal can contribute to greater transparency and efficiency in the regulation of medical devices and IVDs, ultimately enhancing public confidence in the quality, safety, and efficacy of these products marketed in India.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. SUGAM Portal: An e-Governance portal used by CDSCO for online application submissions. Medical Device Rules 2017: The regulatory framework governing medical devices and IVDs in India. Medical Device Online Portal (www.cdscomdonline.gov.in): The online system specifically for applications related to medical devices and IVDs. Medical Device and IVD Manufacturing Associations: Industry associations representing manufacturers of medical devices and in-vitro diagnostics.
Official Source Record View Original Source →
See Full Document Text
File No. X-11026/011/18-PRO Government of India Director General of Health Services Central Drugs Standard ControlOrganisation (PRO Division) PUBLIC NOTICE Central Drugs Standard control Organisation (CDSCO), under e­ Governance has rolled out online services for filling of applications through "SUGAM" portal. The online system was launched in 2016 for Import & Registration and subsequently for Cosmetics, GCT, Biological and other divisions. A separate "Medical Device" online portal has also been started in line with new Medical Device Rules-2017 for applications related to medical devices and IVD's. Keeping in line with Govt of India's vision to promote Digital India and Ease of Doing Business, CDSCO thrives to strengthen this online Medical Device portal to enhance public confidence in quality, safety and efficacy of drugs marketed in India as well as to satisfy the applicants. As the "Medical Device" online system (www.cdscomdonline.gov.in) has already been rolled out, it is desired to obtain feedback from the stakeholder to improve the system. A detailed feedback form is enclosed as Annex-I. All stakeholders are requested to provide their valuable feedback as per enclosed format with suggestions about short term, medium term and long term measures to be taken to improve the system. The feedback should be forwarded to feedback@cdsco.nic.in within 2 weeks of this notice in scanned pdf format as well as excel document format. 4{ ,.--­ (Dr. S. Eswara Reddy) Drugs Controller General (India) To, 1. All Medical Device and IVD Manufacturing Associations 2. CDSCO Website for public

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