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Government regulations on medical devices are currently applied to selected medical devices: AHPI DG

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However, he added that it needs to be extended to other equipment to avoid substandard equipment in the Indian market.

HEAL Health considered conducting a discussion on “Medical Device Procurement” and held a live webinar for Episode 21 of the HEAL-Thy Samvaad series on Medical Device Procurement. The Indian Health Providers Association (AHPI) supported the webinar. Knowledge partners were HEAL Foundation, BiOR, BSLA, Senior Care 24×7 and ESI Medtek Solutions.

While discussing the challenges of procuring medical devices at the webinar, Neuberg Diagnostics Chief Commercial Officer Bhaskar Ghoshal said: The process has many layers and is time consuming. It took me five months to get a license while launching the lab. Some of the major challenges in procuring medical devices are the lack of on-time import / domestic spares, high interest rates on equipment financing, and the hidden costs of equipment and raw material inventories. There are very few medical devices per capita in India. We need to increase our health budget. The Indian medical device and equipment market is currently valued at US $ 12 billion and is expected to grow from 12% to a CAGR of 15%. More Indian manufacturers need to be involved. “

Anil Jauhri, former CEO of QCI’s NABCB, elaborated on the guidance on procuring medical devices, saying: Voluntary registration will end on September 30, 2021 and mandatory registration will begin on October 1, 2021. Since safety and quality are our top priorities for the purchaser, the notified device must be officially licensed and quality guaranteed. However, even for institutional investors, there is no locally available mechanism to guarantee quality. According to AIMED, about 50 COVID-related devices such as ventilators, pulse oximeters, oxygen concentrators, and PPEs are not notified, which does not solve the quality problem of medical devices. Without full regulation, consumer options are limited. “

Elaborating on medical device regulation, OS Sadhwani, a former co-commissioner and drug administrator of the FDA-Maharashtra, said: The Medical Device Regulations will come into effect in 2018 under the Pharmaceuticals and Cosmetics Act of 1940. These rules are in harmony with international regulatory practices and provide comprehensive legislation on the regulation of medical devices that also promotes “Make in India.” Medical devices sold in India should comply with the Bureau of Indian Standards (BIS) or be notified by the central government. If both are not available, the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and ASTM International exist for the standardization of medical devices. “

While discussing the challenges, Dr. Girdhar Gyani, Executive Secretary of the Healthcare Providers Association (AHPI), said: – Availability, accessibility, affordability, and acceptability – Where quality comes. There are specific challenges that hospitals face in procurement. For example, government regulations on medical devices are currently applied to selected medical devices such as MRI, CT scans, and dialysis. However, it needs to be extended to other devices to avoid substandard. Equipment for the Indian market. I would like to purchase a refurbished medical device, but there are no quality control standards. “

Dr. Siva Kumar, an advisor to MedTek Solutions, said: “One of the biggest challenges facing all stakeholders in the medical industry is to provide quality medical care to the general public. To provide high quality output, devices, processes, and Using a high-quality infrastructure from a personnel perspective is essential. The biggest challenge facing healthcare providers is choosing the right type of healthcare equipment for their organization, and therefore the healthcare equipment they need. Understanding the parameters and criteria is paramount when choosing. “

MG Sathyendra, a product compliance consultant at QMART, said of the “risk of fraudulent authentication”: “The most common continuous process for product conformance is testing, inspection and certification. Despite global concerns about the quality of ISO 9001 certification, India lacks integrity and ethics and manufactures. Manufacturers are skipping proper certification. Therefore, if a manufacturer is subject to regulation, it must be approved by the regulator of the product category from regulators such as CDSCO, BIS, AERB. “

Government regulations on medical devices are currently applied to selected medical devices: AHPI DG

Source link Government regulations on medical devices are currently applied to selected medical devices: AHPI DG

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