INDIAN CERTIFICATION FOR MEDICAL DEVICES – (ICMED 9000 / ICMED 13485 / ICMED 13485 Plus )

Introduction

ICMED is India’s first medical devices quality Management system which is the joint voluntary initiative between AiMeD (Association of India Medical Device Industry), QCI (Quality Council of India) & NABCB (National Accreditation Board of Certification Bodies). This encourages ‘MAKE IN INDIA’ movement for the world. India had its own regulations of IMDR, 2017 & with this now it has own QMS and Product Certification.

The objective of certification

• It is aimed at enhancing patient safety and provides enhanced customer protection.
• This was done considering the dire need to eliminate trading of sub-standard medical devices of doubtful origins & malpractices of sub-standard or fraudulent certification or quality audits.
• 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
• Encouraging the Medium scale, small scale, startups companies to maintain their QMS up to an effective mark, by mentioning clear understanding the requirements for QMS
• Designed in considering the Problems of Indian Medical Device Market
• Importance given majorly to Health, Environment and safety Management system requirements.
• Regulatory Requirements of India is covered under it.
• ICMED 13485 forming base for the Product certification i.e. ICMED 13485 Plus in Indian Market. 

Who can apply for certification?

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

Under ICMED scheme, 3 types of certification criteria as mentioned below-

• ICMED 9000 which is based upon ISO 9001 plus additional requirements
• ICMED 13485 based upon ISO 13485 plus additional requirements and
• ICMED 13485 plus based upon ICMED 13485 plus Product specification as per ministry of health and family welfare technical specifications. (Applied  for)

For more details, please visit https://padd.qci.org.in/indian-certification-for-medical-devices-icmed-scheme/

Process flow for Registration of ICMED Schemes

ZENITH ICMED 13485 PLUS APPLICATION KIT