Schemes for industry second

INDIAN CERTIFICATION OF MEDICAL DEVICES (ICMED) SCHEME

To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) is rolling out a voluntary quality certification scheme for medical devices.

The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

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Gujarat Govt. has a scheme to subsidize cost of certification for any certification scheme endorsed/approved by Quality Council of India (QCI). The details are available under their website link http://www.ic.gujarat.gov.in/assistance-for-quality-certification.aspx

It also aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits.

The Scheme has been launched with two levels of certification:-

ICMED 9000 certification which is ISO 9001 plus additional requirements

ICMED 13485 which is ISO 13485 plus additional requirements

Documents And Formats

ICMED 13485 Plus Scheme

Section 1 Introduction

Section 2 Governing Structure

Section 3A Certification Criteria for ICMED 9000

Section 3B Certification Criteria for ICMED 13485

Section 3C Certification Criteria for ICMED 13485 Plus

Section 4A Certification Process for ICMED 9000 and 13485

Section 4B Certification Process for ICMED 13485 Plus