A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 25th Year of Publication
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Cover Story

Medical Device Manufacturing in India - A Sunrise Industry

 

• Similarly, Orthopedics & Prosthetics and Consumables will grow from a cumulative USD 0.90 bn (INR 5,850 crores) in 2015 to USD 1.88 bn (INR 12,220 crores)3 in 2020.
• Dental products and Patient Aids will grow from a cumulative USD 0.47 bn (INR 2,961 Crores) in 2015 to USD 1.1 bn (INR 6,930 Crores) in 2020.

 

• Growing Population
• Ageing Population
• Increasing Disease Burden of Chronic Diseases
• Increasing Health Insurance Penetration
• Growing Medical Tourism
• Demand for Healthcare Infrastructure
• Emerging Healthcare Service Formats
• Quality and Accreditation of Hospiatals as par with International Standards

 

 

Import and Export Trend in Indian Medical Device Market

 

Import and Export Trade in the Last 5 years

 

• The import of medical devices has grown from USD 2.46 bn (INR 15,990 crores) in FY12 to USD 2.87 bn (INR 18,655crores) in FY16.
• The export of medical devices has grown from USD 0.78 bn (INR 5,070 crores) in FY12 to USD 0.98 bn (INR 6,370 crores) in FY16.
• Between FY12 to FY16, the import trade of medical devices has increased by 16.8 per cent, whereas export trade has increased by 25.7 percent.

 

Import Trade of Medical Device

 

• The total import of medical devices is more than 75 per cent of total medical devices sales in India13, however it is estimated that import trade will fall with increasing number of international and Indian manufacturer setting up medical device manufacturing set up in India.

 

AMTZ holds Industry Awareness Training Programme on Quality Certification for Medical Devices Manufacturers

16th August, 2017 - Vadodara

The Andhra Pradesh MedTech Zone (AMTZ), India’s first integrated state-of-the-art medical devices manufacturing park in Visakhapatnam, organized a One - day industry training programme on quality certification with an aim to bring down the time and cost-run to obtain globally accepted quality certification for Indian manufacturers.

The training programme, held on 9th August in Coimbatore and 16th August on Vadodara and attended by medical devices manufacturers, medical professionals from Healthcare & Academics and other industry stakeholders, was organized in association with Quality Council of India (QCI), National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry (AIMED).

The programme mainly focused on helping medical device manufacturers to understand Industry Certification for Medical Devices (ICMED) certification and New Medical Device Rules, 2017 which are effective from 01st January 2018.

The programme’s objective was to fill the regulatory space in quality certification for medical devices in the country. The key themes of the training sessions included EU regulatory, medical device definition, life process and device risk classification; CE Marking and New MDR; ICMED 9000 certification, which is ISO 9001 plus additional requirements; ICMED 13485, which is ISO 13485 plus additional requirements; and New Medical Device Rules, 2017.

Thanking QCI and NABCB for organizing the event jointly “to exchange the knowledge share of regulations and certification process for the medical device”, Dr Jitendar Kumar Sharma, CEO and Director, AMTZ, said: “With this event, we will aim to create a more progressive practice towards regulatory frame work in the medical device sector.”

Dr. D L Pandya, CEO, Medical Plastics, applauded AMTZ and QCI organizing such first India’s industry awareness program on ICMED and MDR to boost the quality certification and regulatory requirement to medical device manufacturers in advance.

Mrutunjay Jena, Joint Director, QCI, said, “QCI & AIMED in partnership with AMTZ is initiating a number of voluntary awareness Programs to facilitate industry and demonstrate compliance to the best global standards of which ICMED is one of them.”

 

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