As a medical device consultancy, we are pleased to share a significant announcement made by the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Govt. Of India.
The DoP recently announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)”.
Niti Aayog and the DoP had identified a few factors that were contributing to a 10-15% disability factor in being globally competitive, and one of them was inadequate infrastructure.
The Association of Indian Medical Device Industry (AiMED) commented on the scheme saying “While Medical Device Parks as planned clusters with shared common manufacturing and testing or warehousing and clearing facilities were being encouraged to help reduce the CAPEX (capital expenditure) of manufacturers, it was also important to strengthen the existing manufacturing natural clusters that existed in different parts of the country eg. The Delhi NCR cluster is traditionally strong in medical disposables, surgical instruments, orthopaedic implants and IVD Reagents.”
To read more on the update by DoP: Click Here to view PDF
This scheme aims to strengthen new and existing medical device manufacturing facilities by providing financial assistance as well as establishing more testing laboratories. The government aims to provide an ecosystem to the medical devices companies for all the involved complementary industries. This will strengthen the industry, especially the new entrants in the medical devices manufacturing.
Major challenges faced by the new entrants are as below:
Limited Availability of Medical device designers: As there are numerous medical devices in the market. There are different experts for every different technology.
Testing laboratories and their availability.
Lack of understanding of regulation and compliances: Medical devices regulation fairly new for Indian manufacturers, especially for new entrants.
Operon strategist is a company vastly experienced in assisting new entrants in medical devices industry. We suggest the best regulatory pathway for the compliance for Indian and foreign approvals like CE marking, USFDA etc. Contact us to know more about medical devices regulations.
