NIPER to get into testing of medical devices

National Institute of Pharmaceutical Education and Research (NIPER), a body under the department of pharmaceuticals, will now get into testing of medical devices manufactured in India.

The institute is now applying for accreditation to become a testing lab after which it will go on to test various kinds of implants.

“The department of pharmaceuticals felt the need to have more testing laboratories in India for medical devices manufactured here. We, at NIPER have the expertise to test orthopedic implants, dental implants and stents. So, we will use it”, says Kiran Kalia, director, NIPER Ahmedabad.

After testing, NIPER would be giving a test report of these devices which manufacturers can take to government agencies for further certification or approvals. While most of the testing currently happens once the production is done, here the NIPER will be testing the strength of products going into the manufacturing of these products.

“A lot of these devices require high-end testing equipment and manufacturers send it abroad. NIPER has all the equipment required to test such devices. Being able to test in India will boost the make in India mission”, says Kalia.

With this, the government feels production costs will come down as testing can be done within India. Currently, India imports almost 80% of its medical devices from the US, Germany, China, Singapore and Netherlands among other countries. Meanwhile, on the quality assessment side, the government recently announced the Indian Certification of Medical Devices (ICMED) 13485 Plus which has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications.

“ICMED 13485 as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices”, the government had said in its statement.

The Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) in collaboration with the Association of Indian Medical Device Industry (AIMED) have rolled out a voluntary quality certification scheme for medical device industry in the country.