CME On Pharmacology on 15th July 2023 – Announcement

CME on PHARMACOLOGY – TOPIC : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES on 15th July 2023

Government of Karnataka Shri Atal Bihari Vajpayee Medical College & Research Institute, Bengaluru formerly called Bowring & Lady Curzon Medical College & Research Institute, DEPARTMENT OF PHARMACOLOGY jointly organised with NCC-MvPI, IPC & RTC-MvPI NIMHANS, Bengaluru conducting CME on 15thtJuly 2023

Topic : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES

Mode : Hybrid

Time : 9 am to 4 pm

Fee : Rs. 200

Venue: Lecture Hall 3, SABVMCRI, Bengaluru

Contact : Dr. Nishitha S B @ 9591040864

Who can register: Medical, Dental, Nursing, AHS , Paramedical, Pharmacy, AYUSH, Physiotherapy – faculty/Students, Health Department Officials & Industry Professionals

Registration Link : REGISTRATION FORM (google.com)

For any queries please contact Dr. Nishitha SB: 9591040864 / Dr. Poorvi M: 7259349749
Email: amcsabvmcri@gmail.com

Cybersecurity in Medical Devices

FDA requires medical devices be secured against cyberattacks

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase potential cybersecurity risks. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.

Under FDA guidance issued this week, all new medical device applicants must now submit a plan on how to “monitor, identify, and address” cybersecurity issues, as well as create a process that provides “reasonable assurance” that the device in question is protected.

Applicants will also need to make security updates and patches available on a regular schedule and in critical situations, and provide the FDA with “a software bill of materials,” including any open-source or other software their devices use.

As part of the new law, the FDA must also update its medical device cybersecurity guidance at least every two years.

Source: https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

The Ministry of Health and Family Welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.

A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.

The State Government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government. The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1

PHDCCI Conference

Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)

Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:

Day & Date: Friday, 24 June 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights
• Regulation of medical devices and recent amendments
• Steps to Licensing for Class A & Class B Devices/Products
• QMS requirements for Medical Devices
• Demonstrating Product Compliance as per MDR-17
• Challenges faced by Medical Devices Manufacturers

Key Speakers
• Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications
• Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi
• Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

You may send your questions to rimneet.kaur@phdcci.in prior to the session.
The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in