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IS/ISO 14155 : 2020

IS/ISO 14155 : 2020 — Clinical investigation of medical devices for human subjects - Good clinical practice

IS/ISO 14155 : 2020 is an Indian Standard titled Clinical investigation of medical devices for human subjects - Good clinical practice, classified under Medical and Hospital Equipments and administered by the Ministry of Consumer Affairs, Food and Public Distribution - Department of Consumer Affairs. Certification is voluntary.

IS Number
IS/ISO 14155 : 2020
Status
0
Certification
Voluntary
Ministry
Ministry of Consumer Affairs, Food and Public Distribution - Department of Consumer Affairs
Committee
In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices
Type
Methods of tests

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What is IS/ISO 14155 : 2020?

IS/ISO 14155 : 2020 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Clinical investigation of medical devices for human subjects - Good clinical practice. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Consumer Affairs, Food and Public Distribution - Department of Consumer Affairs. Certification under this standard is voluntary.

How to get certified for IS/ISO 14155 : 2020

  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.
View official document on bis.gov.in →

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