As a step towards protecting industry from faulty medical devices and reliance on international certifications, Andhra Pradesh MedTech Zone (AMTZ) recently signed an MoU with the Quality Council of India (QCI) to promote Indian Certification for Medical Devices (ICMED) Scheme in India.
Developed in collaboration with AiMeD, QCI and the NABCB – ICMED is a quality certification scheme for medical devices in the country with an aim to enhance patient safety, and increase consumer protection along with providing much needed product credentials to manufacturers to instil confidence among buyers.
The scheme is also intended to significantly eliminate trading of sub-standard products or devices where supply chains are unknown, a widespread and injurious occurrence in the Indian market.
The MoU was signed by Dr. Jitendar Sharma, chief executive officer, AMTZ and Dr. R. P. Singh, secretary general, QCI in the presence of Dr. Kamineni Srinivas, Health and Medical Education Minister, Government of Andhra Pradesh; Dr. Poonam Malakondaiah, principal secretary, Health Medical & Family Welfare, Government of Andhra Pradesh; Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD); Anil Jauhri, chief executive officer, National Accreditation Board for Certification Bodies (NABCB); and Mrutunjay Jena, joint director, NABCB and other distinguished guests.
Currently, with no established mandatory quality certifications for medical device manufacturing sector in India, the medical devices manufactured in India lack an element of competitiveness with respect to the imported medical devices.
With manufacturers forming a bee-line to start manufacturing at AMTZ, this collaboration with QCI would help the manufacturers be ICMED compliant from the first day itself.
AMTZ and QCI would be working closely in this direction by joint selection of agencies for empanelment for promotion of quality in medical devices and even facilitating manufacturing of identified technologies at AMTZ.
AMTZ which is India's first medical devices manufacturing park has already announced bookings of factories at a refundable fee of Rs.6,250; Rs.12,500 & Rs.25,000 for a 0.25 acre; 0.50 acre and 1.00 acre manufacturing unit respectively. AMTZ has been receiving bookings continuously since the launch of booking on 2nd October.
Government of Andhra Pradesh and senior management of Andhra Med Tech Zone had also led an ‘exclusive investors meet’ at world’s largest and most attended medical devices expo -Medica on November 15, 2016 at Dusseldorf, Germany. This was AMTZ first international summit at Dusseldorf.
Dr. Jitendar Sharma said that the response from industry has been very encouraging and 10 per cent of the proposed factories have already been booked since October 2, 2016 when the booking for AMTZ was launched. The zone has received applications from some of the largest companies.
AMTZ would include facilities such as component testing centre, electro-magnetic interference laboratory, medical grade low vacuum molding, cabinet molding, injection molding centres, 3D designing and printing for medical grade products, sterilization and toxicity testing centre, radiation testing centre, gamma irradiation facility, rapid prototyping centre, warehousing and regulator’s office.