Medical Device Rules 2017 Archives

Workshop on Indian Medical Device Regulations

IBSC – AMTZ is organising a Workshop on Indian Medical Device Regulations

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices

LEARNING OBJECTIVE

Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices.

COURSE AGENDA

Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
Classification of Medical Devices
Basic Requirements
Content Requirements for Technical Documentation
Validity of Conformity Assessment and Certification, Transition Periods
Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

Medical device manufacturers
Consultants
Regulatory Affairs Specialists
Expert advisors in medical devices regulatory affairs
Working biomedical engineers / medical device professionals
Pursuing Students are also eligible

Fee: INR 3,540 including 18% GST

CANDIDATES WILL BE PROVIDED WITH IBSC CERTIFICATE

LAST DATE FOR REGISTRATION: 30th May 2023

TRAINING DURATION: 2 DAYS (9th & 10th June 2023)

LOCATION: Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore

For more information, please contact

Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990 | +91-7075737284
WhatsApp Link: https://wa.me/918897330990
WhatsApp Link: https://wa.me/917075737284
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

No extension in deadline for registration of medical devices to manufacturers – Announcement from Union Health Minister

Medical Devices in India will come under the licensing regime from October 1 as notified by the Central Government. Class A and B Device manufacturers, importers have to in compliance with MDR 17 and should have Registration and Licensing in place before Oct 1 2022 to have market access.

Union Health Minister Shri Mansukh Mandaviya has stated in a recent press release that there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe. He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration for seamless process.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action after Oct 1 , 2022. The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon.

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

Source :
https://health.economictimes.indiatimes.com/news/policy/no-extension-in-deadline-for-registration-of-medical-devices-mandaviya-to-manufacturers/93112960?utm_source=twitter_web&utm_medium=social&utm_campaign=socialsharebuttons