The draft National Medical Device Policy-2015, issued recently by the Department of Pharmaceuticals (DoP), has mandated several institutional frameworks such as common medical device testing centres, Centres of Excellence, Made in India marking (BIS) specific to medical devices and a Skill Development Committee under National Medical Devices Authority.

As per the policy, common medical device testing facilities,  preferably in the PPP mode, should be set up by government in major medical device manufacturing hubs to facilitate testing/evaluation of medical devices. Recurring expense can be borne by the industry.

The policy further mandates to designate 'Centres of Excellence' (CoE) for supporting product development and validation which are having existing requisite facilities and expertise for different categories of medical devices (Example: Department of Electronics and Information Technology (DeitY), Bureau of Indian Standards (BIS), Indian Institute of Technology, Madras (IlT-M), Indian Institute of Technology, Delhi (IIT-D), Indian Institute of Science, Bengaluru (IISc-B), Central Institute of Plastics Engineering & Technology (CIPET), and Defence Research and Development Organization (DRDO).

These Centres of Excellence would support product development, design and prototyping; validation and certification of the medical use of devices; and adopt, implement and advocate policies on efficacy and safety testing.  

The policy also mandates to strengthen a Made in India marking (BIS) specific to medical devices in line with international standards like CE and FDA.

As per the policy, a Skill Development Committee should be set up under National Medical Devices Authority with representatives from medical devices industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC), which would identify skill gaps and reduce shortages; design curriculum and explore possibilities for on-line/e-learning modules to meet specific requirement of medical device segment; the committee would engage with HSSC affiliated vocational training providers as well as potential ITIS, polytechnic and other institutes for skill development; set up satellite training campus around manufacturing hubs for skill upgrading; liaise across the medical devices industry for job placements; and provide counselling to candidates seeking skill development and address issues like student loan, scholarships, job placements, etc.