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Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)

India, Uttar Pradesh, Achhnera
Last update 2 years ago
ID #82770
    - Offline
0.0
1 photo
201301.00 INR
Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)
India, Uttar Pradesh, Achhnera,
Modified 2 years ago

Description

Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.

Together with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), the Association of Indian Medical Device Industry (AIMED) has developed a voluntary quality certification scheme for medical devices in India, Indian Certification for Medical Devices (ICMED)

It is the country's first indigenously developed quality assurance system mandatory for all medical devices marketed in the nation. This was proposed in a recent meeting called for the drafting of (separate) rules for medical devices with government officials with a special focus on drafting regulatory framework for the granting of medical device manufacturing licenses.

The meeting discussed how to proceed with the registration of manufacturers and importers of medical devices on an online GoI portal. Most importantly, the meeting stressed the need for the registration of low-risk and moderate-risk devices based on certification by 3rd Party (CAB) and the granting of a manufacturing license to manufacturers and importers of high-risk devices based on specified criteria. This will be achieved by CDSCO medical devices officers with a predefined competency or by certification bodies of 3rd party according to sources. www.corpzo.com

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Additional information

Mobile Number: 09999139391
Type of ad: I want to sell
Website: www.corpzo.com
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    Seller's picture
    Private person
    Registered on 20. Dec 2021

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    Norway
    Seller's picture
    corpzo
    Rac_246394
    09999139391
    1 item
    None

    201301.00 INR
    Add to cartAvailable: 1x
    Contact seller 0999913xxxx
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    Seller's info

    Seller's picture
    Private person
    Registered on December 20, 2021

    Listing location

    India, Uttar Pradesh, Achhnera
    G 41, Sector 63, Noida
    Rackons Market - Osclass Apps