+91 9607006692 / 6823 / 6973 / 6945 / 4749

Introduction

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 implied to all medical devices in the nation. This encourages ‘MAKE IN INDIA’ movement for the world.

The objective of certification;

  • It is aimed at enhancing patient safety and provides enhanced customer protection.
  • The scheme is intended to significantly eliminate the trading of sub-standard products or devices.
  • Most significantly, it will reduce considerable time and costs for Indian companies to receive internationally recognized quality certification,

Benefits of certification

  • Build brand trust of medical devices manufactured in India
  • Enhance patient safety
  • Provide healthcare users with quality medical devices manufactured in a certified facility

Who can apply for certification?

  • Indian manufacturer or exporter
  • Indian medical device importer/distributor

ICMED certification is of two types:

  • ICMED 9000 (an ISO 9001plus additional requirement) – This certification is for low-risk medical devices
  • ICMED 13485 (an ISO 13485 plus additional requirement) – This certification is for medium or high-risk devices.

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Contact us

Siddhesh Optimus, B Wing, 01A, S.No. 211, Viman Nagar, Pune – 411014, MH, India

+91 9607006692 / 6823 / 6973 / 6945 / 4749

Know About us

Zenith Quality Assessors Pvt. Ltd. operates quality management system certification schemes, product certification schemes and testing activities under internally designated business divisions

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Zenith Quality Assessors Pvt Ltd is always committed to continually maintain highest standard of business ethics and professional integrity in all its activities across the organization

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