Voluntary Registration of Medical Devices & Labelling Norms – Medical Device Sector – Fresh Announcement from CDSCO

Medical Device Industry has recently sent a representation to the Regulator – CDSCO, to consider timeline extensions to the Voluntary Registration Program announced by the Regulator in April 2020. Though the 18 months timeline offered by the Regulator came to an end on Sep 30th 2021, many MSME businesses couldn’t complete the process . Regulator has forwarded the request to Ministry . A Session with Regulator organized by industry was attended by more than 1000 members and industry and various other key stakeholders raised many pertinent issues requesting the regulator’s office to look into. One of the key issues raised during industry meet was ISO 13485 Certification process and challenges in completing the exercise to obtain “Authentic ISO 13485 Certificates” .

Industry is waiting for further instructions from Regulator’s office on the timelines extension to the Voluntary Registration Process.

Fresh Notification from #CDSCO

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. The announcement is more specific to ISO 13485 Certificates and the Self declaration to be given by Industry to Regulators about the roadmap to complete the certification process.

CDSCO has called for feedback , suggestion from the industry to the proposed amendments. Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification.

Download the notification from here

Request the industry, stakeholder to share feedback with Regulators, Industry Associations etc to the proposed amendments.

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