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ICMED trains manufacturers at AMTZ to fill regulatory gap in certification for medical devices

Manufacturers, 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 at a training workshop organized 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” was aimed at bringing down the substantial time and cost-run to obtain internationally 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 necessities, ICMED 13485 which is ISO 13485 plus additional necessities and new medical device rules, 2017.

Dr Jitendar Kumar Sharma, chief executive officer, AMTZ said, “We are extremely thankful to QCI and NABCB for organizing this event jointly to exchange the knowledge share of regulations and application procedure 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 worldwide standards of which ICMED is one of them”.

As a step towards protecting industry from faulty medical devices and reliance on international certifications, AMTZ has signed a MoU with the QCI to promote ICMED Scheme in India.

Developed in collaboration with AIMED, India’s apex quality facilitation and national accreditation body QCI and the NABCB, ICMED is a quality certification scheme for medical devices in the country with an aim to improve patient safety, and growth consumer protection along with providing much required product credentials to manufacturers to instil confidence among buyers.

The scheme is also intended to significantly remove trading of sub-standard products or devices where supply chains are unknown, a widespread and injurious occurrence in the Indian market.

QCI on March 15, 2016 launched the voluntary certification scheme named ICMED - the first indigenously developed global class certification scheme for the medical devices in India to decrease time and cost-run for obtaining internationally accepted quality certification for Indian companies thus eliminating the malpractices of sub-standard or fraudulent certification or quality audits.

ICMED will also fill a big regulatory void as there was no India-specific official quality assurance system till date, due to which Indian medical device manufacturer’s encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits.

AMTZ at Visakhapatnam which is India's first medical devices manufacturing park would include facilities like component testing center, electro-magnetic interference laboratory, medical grade low vacuum molding, cabinet moulding, injection moulding centres, 3D designing and printing for medical grade products, sterilization and toxicity testing center, radiation testing center, gamma irradiation facility, rapid prototyping center, warehousing and regulator’s office.

 

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