IS/ISO 20417 : 2021 — Medical devices Information to be supplied by the manufacturer

What is IS/ISO 20417 : 2021?

IS/ISO 20417 : 2021 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical devices Information to be supplied by the manufacturer. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare. Certification under this standard is voluntary.

How to get certified for IS/ISO 20417 : 2021

1. 1
   Apply online — Submit the BIS portal application with product details, factory information, and test reports.
2. 2
   Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
3. 3
   Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
4. 4
   Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.

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