22 February 2022
PHD Chamber of Commerce and Industry (PHDCCI) organized first in the series, Interactive Video Conference on MDR 17 on today. The conference was focused on imparting information regarding Challenges of Regulation in Medical Devices. The main aim of the conference was to apprise the various participants of medical field about the nationally recognized Standards of medical devices and other regulatory requirements concerning to the medical devices in India and also to address the key challenges faced by medical device manufacturers.
The session was kick started by the Session moderator, Col. Rajiv Bhargava (Retd.), Associate Director, Indian School of Business. In his welcome note he said that India is the 4th largest market of Medical Devices in Asia and one of the top 20 markets in the world. As per the future projections, the Indian market of medical devices is expected to reach to the worth of 50 billion USD by 2025.
Further, Mr. M S Vij, Chair, Chandigarh Chapter of PHDCCI continued the welcome remarks and stated that the medical devices sector in India comprises of large multinationals as well as small and midsized companies.
During this, Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India showcased a detailed presentation giving the overview of Indian Medical Device Regulation. He elaborated about the new Notifications for regulation of all Medical Devices covering Risk based classification, Use of Online Portal for medical devices, QMS requirements as per 5th Schedule of MDR Rules, Salient features of 5th Schedule and Registration process & timelines for registering & licensing.
Further, initiating her presentation with the overview of Vigilance in Medical Devices known primarily as Materio-vigilance, Ms. Sushmita Roy, Head- Regulatory Affairs, Andhra Pradesh MedTech Zone (AMTZ) explained about the information on Materio-vigilance Program of India and shared information on India’s Vigilance system in comparison to other countries with regard to Forms & Formats, Guidelines & Timelines.
Mr. P V Mathew, Scientist-E & Head MHD, Bureau of Indian Standards (BIS) apprised the participants with a ‘wealth of information’ on process of standard formulation, Harmonization of Standards and use of consensus to reach the standardization.
A comprehensive presentation on the challenges faced by Medical Device Manufacturer was presented by Mr. Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd & Forum Coordinator, Association of Indian Medical Device Industry (AIMED).
Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat shared his experience with the steps taken by Government during Covid times by relaxing approvals.