Last Updated on December 31, 2023 by The Health Master
Training for Medical Device Officers
The Central Drugs Standard Control Organisation (CDSCO) has taken a significant step towards the effective implementation of the new Medical Device Rules (MDR) 2017 by commencing training sessions for Medical Device Officers from the Food and Drug Administration in Gujarat and Maharashtra.
Compulsory Registration for Medical Device Companies under MDR 2017
The new MDR 2017 mandates the compulsory registration of medical device companies engaged in manufacturing Class A, B, C, and D devices.
The deadline for registration is set for October 1, 2023. This move is geared towards establishing a robust framework for the execution of the new MDR licensing system.
Equipping Medical Device Inspectors through Training
To ensure a smooth transition and effective implementation of the new regulations, a series of training sessions have been organized for approximately 80 notified medical device inspectors who also serve as drug inspectors in Maharashtra.
The training is designed to equip these inspectors with a comprehensive understanding of various aspects related to medical devices.
This includes proficiency in the performance of medical devices, validation procedures, documentation requirements, risk-based assessments, and the quality management system (QMS).
Collaborative Efforts in Maharashtra
The Maharashtra Food and Drug Administration (FDA) has taken a phased approach to empower all 80 drug inspectors to function as medical device inspectors.
This strategic move aims to regulate all classes of medical devices under the Drugs and Cosmetics (D&C) Act.
This authorization is part of a meticulous plan to ensure effective compliance with the new MDR regulations.
Gujarat’s Comprehensive Approach
Similarly, the Gujarat Food and Drug Control Administration (FDCA) has designated all 89 drug inspectors as medical device inspectors.
This initiative encompasses an extensive training program in collaboration with the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, and other stakeholders.
The training endeavors to familiarize these medical device inspectors with the intricacies of the new MDR, encompassing areas such as performance, safety, and QMS.
MDR 2017 and Effective Implementation
The MD Rules 2017 were officially notified on February 11, 2022, and have been in effect since January 1, 2018.
These rules set the groundwork for addressing issues related to post-grant compliance, data protection, product recalls, and product liabilities.
These measures are pivotal to ensuring the safety and efficacy of medical devices in the market.
Classification and Auditing Process
Under the new MD Rules, State Licensing Authorities (SLAs) are tasked with submitting applications to notified bodies for the inspection and auditing of Class A and Class B medical devices.
Conversely, the CDSCO independently audits Class C and Class D medical devices.
This approach ensures that the regulatory framework aligns with the specific risks and complexities associated with different classes of devices.
Transition to Licensing System
Following consultations with the Drugs Technical Advisory Board (DTAB), the Central Government introduced the MDR-2017 on January 1, 2018.
Medical devices were initially subjected to a voluntary registration scheme from April 1, 2020, to September 30, 2021.
Subsequently, Class A and B medical devices became part of a mandatory registration scheme from October 1, 2021, to September 20, 2022.
Class C and D medical devices are also subject to mandatory registration until September 20, 2023.
After this registration period, these categories will transition to a licensing system.
Regulation for Growth
The medical device sector, historically underregulated, is poised for transformation through the MDR 2017.
These rules, framed by the Union health ministry, are designed to comprehensively regulate medical devices in a phased manner.
With an expected market size growth from US$ 11 billion to US$ 50 billion by 2025, these regulations are crucial for ensuring quality, safety, and efficacy within the industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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