ICMED training at AMTZ to fill regulatory gap in quality certification for medical devices in the country

Medical Device IndustryManufacturers, medical devices professionals and other stakeholders got orientation and hands-on-experience on fundamentals of EC regulations and CE Marking, Indian Certification for Medical Devices (ICMED) Scheme and New Medical Device Rules, 2017 in a training workshop organised by Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam in partnership with Quality Council of India (QCI), National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry (AIMED).

The Industry Programme themed “Understanding EC Regulations and CE Marking and ICMED Certification and New Medical Device Rules, 2017 for Medical Device Manufacturers” aimed at bringing down the substantial time and cost-run to obtain globally accepted quality certification for Indian manufacturers.

It gave a low down on aspects related to EU regulation, Medical Device Definition and Risk Classification, CE Marking, ICMED 9000 certification which is ISO 9001 plus additional requirements, ICMED 13485 which is ISO 13485 plus additional requirements and new medical device rules, 2017

Dr Jitendar Kumar Sharma, CEO, AMTZ said, “We are extremely thankful to QCI and NABCB for organizing this event jointly to exchange the knowledge share of regulations and application process for the medical device. With this event, we will aim to create a more progressive practice towards regulatory frame work in the medical device sector”

Mrutunjay Jena, Joint Director, QCI said,“QCI & AIMED in partnership with AMTZ is initiating a number of voluntary awareness Programs to facilitate industry and demonstrate compliance to the best global standards of which ICMED is one of them”.

 

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