IS/ISO 13485 : 2016
IS/ISO 13485 : 2016 — Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
IS/ISO 13485 : 2016 is an Indian Standard titled Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ), classified under Medical and Hospital Equipments. Certification is voluntary.
- IS Number
- IS/ISO 13485 : 2016
- Status
- 0
- Certification
- Voluntary
- Committee
- Hospital Planning
- Type
- System Standard
Need ISI Mark certification for IS/ISO 13485 : 2016? Fixed-fee, 6–12 week timeline.
Get a quoteWhat is IS/ISO 13485 : 2016?
IS/ISO 13485 : 2016 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ). It falls under the <strong>Medical and Hospital Equipments</strong> group. Certification under this standard is voluntary.
How to get certified for IS/ISO 13485 : 2016
- 1Apply online — Submit the BIS portal application with product details, factory information, and test reports.
- 2Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
- 3Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
- 4Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
Complyris an independent compliance consultancy. We are not affiliated with, endorsed by, or representing the Bureau of Indian Standards or any government body. All Indian Standards are © Bureau of Indian Standards. Visit bis.gov.in for official standard documents.
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Fixed fee. End-to-end handling. We manage the entire BIS certification process.