Medical Device Regulations – Materiovigilance Program of India – News Letter from IPC
News Letter from IPC on Materiovigilance Program is shared below for information.
Since Medical Devices are brought under Full Regulations in the country, one of the mandatory Regulatory Requirement is Market Surveillance by Regulator .
Read the news letter shared below for more information
Invitation to All to join WSD 2023 Celebrations
Oct 14th is Celebrated World over as World Standards Day.🎊
CCC(Consultants Consortium of Chennai) and MSCC(Management Systems Consultants Consortium) are organising a webinar on Oct 14th 2023 from 4 pm–5 pm.🗓️
WSD Theme this year : Shared Vision for a better World – Incorporating SDG 3
SDG 3 is all about Good Health and Wellbeing 👩🏻⚕️
In alignment with Global Theme,we have scheduled a webinar on the following topic:
Healthcare Quality Assurance – Standards ✅
ISO has released a Healthcare QMS Std – ISO 7101, for the first time globally.🏥
Pharma Sector is witnessing Global MS Standards in Pharma Manufacturing as well💊
Medical Devices Sector is racing towards implementing MDQMS 🩺
Session on Healthcare Quality Assurance is designed to Educate Healthcare Sector – be it Services or Products , and various other stakeholders, about various Healthcare Quality Assurance Standards which are introduced globally to improve the Healthcare Quality Focus across the globe.
Healthcare Services can’t offer Assurance on its Quality when its Supply Chain, Value Chain Quality is not in alignment with its Quality Assurance Framework.
Time to LEARN, UNLEARN and RELEARN 🧑🎓
Prog Info :
Date : Oct 14, 2023
Time : 4 pm – 5 pm
Meeting Mode : Zoom Meeting
Fee – No Fee. Free for all 🆓
Registration Link :https://us02web.zoom.us/meeting/register/tZwsd-uhrD8rHdXTn3awk0eCxcSxAzqqSg20
Prior registration is a must. All registered delegates will receive direct mail from ZOOM, CCC Secretariat and also a SMS.
For Prog info, updates, visit – https://ccc-consultants.org/world-standards-day-2023/
For queries , pls mail :
CCC – contact@ccc-consultants.org
MSCC – info@msccglobal.com
IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System
COURSE OUTCOMES:
a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·
d. Understanding how to meet regulatory requirements leading to increased patient safety
Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student
Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in
Program Details: https://www.ibsc-amtz.in/coursedetails/30
Last Date for Registration: 7th October 2023
For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in
Regulatory Awareness & Experiential Learning Workshop for Medical Device / Diagnostic Innovators / Start-ups in India
Indian Council of Medical Research (ICMR)is conducting a Regulatory Awareness & Experiential Learning Workshop for Medical Device/Diagnostic Innovators/Start-ups in India jointly with Central Drugs Standard Control Organisation (CDSCO) on 12th Oct 2023 at ICMR Hqrs, New Delhi.
Date of the Workshop – 12th October 2023
Time – 10 am to 5 pm
Venue – Conference Hall, ICMR Hqrs, New Delhi
Mode of workshop – Hybrid mode
Last Date for Registration – 30th September 2023
Registration Link – https://docs.google.com/forms/d/e/1FAIpQLSeQZCq00-CnvqpG-tUZRHF43fc3gthxkGvVSl-3KP9FrmKyqw/viewform
Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing
Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments
Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.
The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments
In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :
Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme
| Program on Healthcare Textiles Processing Facility Certification Scheme The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again. Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis. This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider. These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI). Date: 27th May 2023 Time: 3:00 pm to 6:00pm IST Mode – Virtual Mode / Webinar |
Govt releases Guidelines for scheme for Assistance to Medical Devices Clusters
The Department of Pharmaceuticals (DoP) has come out with the guidelines for the scheme for Assistance to Medical Device Clusters for Common Facilities (AMD-CF) with proposed financial outlay of Rs. 300 crore to offer financial assistance to strengthen the existing and new medical device clusters through creation of common infrastructure facilities
The Scheme, with two sub-schemes, is expected to help in boosting the domestic manufacturing capacity and improving the quality of clusters for sustainable growth of the medical devices sector.
The scheme further intends to support central or state governments, institutions, or organisations to establish or strengthen the testing laboratories for medical devices to meet the needs arising due to the roll out of the licensing regime of the Medical Devices Rules (MDR), 2017.
The Scheme has two components or sub schemes – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF) – and would be running for three years from 2023-24 to 2025-26. The tenure of the scheme is from the financial year 2023-24 to the financial year 2026-27.
Both the sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore (Rs. 48 crore in the first year, Rs. 128 crore in the second and Rs 64 crore in the third year) for the common facilities and Rs. 60 crore (Rs. 18 crore for the first, Rs. 30 crore for the second and Rs. 12 crore for the third year) for the testing facilities.
Assistance for Common Facilities is planned to strengthen the medical devices clusters’ capacity for their sustained growth by creating common infrastructure facilities.
Medical devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facilities and the clusters promoted by the State governments, are expected to benefit from the sub-scheme.
There shall be a minimum of five medical device manufacturing units as members of SPV. Clusters promoted by state governments may not need to form an SPV.
The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV.
For Common Infrastructure Facilities for medical device clusters, the limit of support will be 70 per cent of the approved project cost or Rs. 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC).
The sub scheme is expected to have benefits including improvement in quality of medical devices, regulatory compliance specified for medical devices, increased availability of trained personnel for the clusters, increased competitiveness of units in the cluster and reduction in the manufacturing cost of the devices.
The sub scheme on assistance for Testing Facilities is aimed at strengthening availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices, and national or state level government of private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including in vitro diagnostic medical devices under MDR, 2017 can apply for the assistance.
The guideline proposes a Technical Committee constituted by the DoP to assist the SSC, which will have one representative each from the Central Drugs Standard Control Organisation (CDSCO), industry and academia, and ICMR, and two representative experts having knowledge and experience in the process development, R&D, product design, testing of medical devices or medical devices manufacturing from relevant institutes such as NIPER, IISc, IITs, Sree Chitra Thirunal Institute of Medical Sciences and Technology, and CSIR, among others.
The DoP will provide overall policy, coordination and management support for the implementation of the Scheme, while the proposals under the scheme will be considered for approval by the SSC, which will be headed by the Secretary of DoP as the Chairperson, and will have members including the Drugs Controller General of India, Financial Advisor of DoP, Joint Secretary (Schemes and Medical Devices), DoP, representatives of the Ministry of Micro, Small and Medium Enterprises (MSME), the Ministry of Electronics and Information Technology (MeitY), the Department for Promotion of Industry and Internal Trade (DPIIT), and the director or the deputy secretary (Schemes) of the DoP.
Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of Drugs and Cosmetics Act 1945
Drugs Controller General of India has issued a letter to all States / UTs Drug Controllers and Pharmacy Council of India on strict Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of D&C Act 1945 on the following:
THE MEDICAL DEVICES RULES, 2017
The draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government.
All objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the Medical Devices Rules, 2017
These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018
These rules shall be applicable in respect of,—
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 2 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
Source:https://www.drugscontrol.org/pdf/Medical%20Devices%20Rules,%202017.pdf
NMC Mandate Enrolment of Medical Colleges as ADR monitoring centers under PvPI
Aiming to uplift regulatory standards for the overall collection, analysis and monitoring of Adverse Drug Reactions (ADRs) from the Public, National Medical Commission (NMC) has directed all medical colleges, standalone PG Institutions to enrol themselves as Adverse Drug Reaction Monitoring Centers with the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Program of India (PvPI) at the earliest.
Indian Pharmacopoeia is functioning as the National Co-ordination Centre, Pharmacovigilance Programme of India to collect, analyse and monitor the adverse drug reactions from the Indian population to promote Patient Safety and Safeguard the health of patients by ensuring that the benefits of the use of medicines outweigh the risk associated with its use
The collected ADRs data is a significant source of evidence of recommendations of regulatory interventions regarding the safety of medicines to the Central Drugs Standard Control Organisation (CDSCO)
In order to achieve the above objective, IPC has so far enrolled 652 Adverse Drug Monitoring Centres (AMCs).
In the 22 nd Meeting of the Governing Body of India Pharmacopoeia Commission held on 14.10.2022 under the chairmanship of the Secretary (HFW) it has been decided that all Medical colleges/ hospitals under the National Medical Commission should also be enrolled as AMCs with IPC.
Accordingly, all Medical colleges/hospitals under the National Medical Commission are directed to get themselves enrolled with Indian Pharmacopoeia Commission (IPC) as AMCs at the earliest.
Source:https://medicaldialogues.in/
