Our 30th Year of Publication

From Editor's Desk

Indian Medical Device Manufacturing Industry: Ecosystem Evolving For Better.

A Parliamentary Committee on Health has made very useful and relevant recommendations for manufacturers and related shareholders as detailed by Mr Rajivnath, Forum-coordinator, AiMeD in his article covered in this issue along with various other important components of the ecosystem. As highlighted by Mr Rajinath, among many, the key recommendations as shortlisted in the article are :

• A separate legislation for Medical Devices with a new set of regulators having qualifired and well-trained Medical Device Officers.
• Expansion of PLI scheme to cover Raw Materials and Components
• Creation of a separate Department of Medical Devices
• Preferential Government Purchase for Indian Manufactured Medical Devices.
• Allowing 3rd party assurance schemes like ICMED 13485 for QMS particularly for Class C & D products..

Mr. D.L. Pandya


The other important cover story in this issue is on “Sterilization Technologies for Medical Plastic Products and Devices”.


The Radiation Processing Department of the Raja Ramanna Centre for Advanced Technology, Indore ( RRCAT ). The facility is licensed by Atomic Energy Regulatory Board ( AERB ), FDA MP State and has ISO 9001:2015 and ISO 13485 : 2016 certification for providing electron beam processing service for sterilization ( e-beam sterilization ) for medical devices as per requirements of ISO 11137.


In a free-wheeling interview to “Medical Plastics Data Service", Mr V C Petwal, Head, Radiation Processing Lab, RRCAT, has given highlights about this first ebeam sterilization facility in the country as well as how the Indian Medical Device Industry can take benefit from this facility.


Cover story includes comparative analysis for various sterilizations methods, introduction to Plasma Sterilization, Radiation Stability of Various Plastic materials as well as global scenario for Sterilization Services by Method.


Importance of ISO 13485 for Medical Plastic Materials & Components Suppliers


Plastics Materials & Components used for medical applications need consistent performance, including resistance to sterilization, chemicals and lipids as well as biocompatibility and toxicity.


Materials & Components suppliers should have thorough understanding of end-use application requirements, medical-device regulations that OEMs must meet, risk management practices and the need for change-control measures in place.


ISO 13485-2016 is the standard governing organizations involved in design, production, and installation and servicing of medical devices. If upstream suppliers, like plastics processors, are also certified to the standard, they provide their customers with the assurance that they have invested in and understand the medical-device risk-management principles that are core to the standard.


Mr Amit Dave, in his continuing column introduces important aspects related to Market Exploration explaining the market selection (or country selection) and why one should choose and go for a market outside India rather than sticking to India only. This article also includes other regular features including Regulatory & Industry New, Event highlights and many more..

D.L. Pandya

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