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

Introduction

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.

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

Benefits of registration

➲  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 type:

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.

Procedure and Documentation

Procedure for certification:

➲  File application form along with required document and fees

➲  The certifying body will raise a query if any within 7 working days from the receipt of application

➲  The applicant will respond to that raised query in the prescribed format

➲  Audit program

For ICMED 9000 & ICMED 13485 the audit cycle shall include:

  • Initial certification audit in two stages (Stage 1 and Stage 2) as per ISO 17021:2011 for ICMED 9000 and ICMED 13485
  • Recertification audits (before end of 3-year validity)

➲  Granting of certification


Documents required for citification:

➲  Organization registration certificate

➲  Organization detail (Manufacturing/importer)

➲  Organization authorized signatory detail (ID and Address proof)

➲  Medical equipment detail

➲  Holding ISO certificate

➲  Importing company detail  and exporting company detail (in case of import)

Stages to obtain Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)

Stage 1

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