Tag: Medical Devices

Industry Update – MeDevIS (Medical Devices Information System) introduced by WHO

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MeDevIS platform announced to boost access to Medical Technologies and Devices

World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System), the first global open access clearing house for information on medical devices. It is designed to support governments, regulators and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing and treatment of diseases and health conditions.

Here are the key insights from the news release about the MeDevIS platform from WHO :

Purpose and Scope: MeDevIS (Medical Devices Information System) is an online platform launched by WHO to provide global open access to information on medical devices. It aims to assist governments, regulators, and users in decision-making regarding the selection, procurement, and use of medical devices across various health conditions.

Coverage: The platform includes information on 2,301 types of medical devices used for a wide range of health issues, including reproductive health, noncommunicable diseases (e.g., cancer, cardiovascular diseases), infectious diseases (e.g., COVID-19), and more.

Complexity and Challenges: The increasing number and complexity of medical technologies make it challenging for healthcare practitioners and patients to navigate. MeDevIS aims to simplify access to reliable international information on medical devices, especially beneficial in resource-limited settings.

Functions and Features: Users can access detailed information about medical devices, including their types, suitable healthcare settings (e.g., community or specialized hospitals), scope of use, required infrastructure, and more. This replaces the need for separate searches across multiple publications with inconsistent naming conventions.

Nomenclature: MeDevIS incorporates two international naming systems for medical devices – the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN). These systems facilitate registration, procurement, regulatory approval, inventory management, and pricing of medical devices globally.

Impact and Benefits: The platform is expected to aid national policy-makers in developing procurement lists and contribute to universal health coverage goals. It can also support health insurance and reimbursement policies, benefiting patients globally.

Future Developments: WHO plans to continually improve MeDevIS by engaging stakeholders and expanding its coverage with additional medical technologies, including those needed in pandemic and emergency settings.

Overall, MeDevIS represents a significant initiative by WHO to enhance access to crucial medical technologies and devices worldwide, streamlining information dissemination and improving healthcare delivery.

Source:https://www.who.int/news/item/08-07-2024-medevis-platform-announced-to-boost-access-to-medical-technologies-and-devices

Industry update

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Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) as Certification Body for ICMED 9000 and ICMED 13485

Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) is awarded provisional approval from the Quality Council of India (QCI) to function as a certification body for the ICMED 9000 (ISO 9001 requirements plus additional requirements specified under the scheme) and ICMED 13485 (ISO 13485 requirements plus additional requirements specified under the scheme) certification schemes.

This accreditation will enable IPC-MvPI to assess the quality management systems of medical device industries, ultimately enhancing the quality of medical devices and ensuring consumer protection

To know more, please visit https://ipc.gov.in/news-highlights/1296-indian-pharmacopoeia-commission-%E2%80%93-materiovigilance-programme-of-india-ipc-mvpi-as-certification-body-for-icmed-9000-and-icmed-13485.html

Source: https://www.ipc.gov.in/icmed-certification.html

CDSCO mandates online safety reporting

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CDSCO mandates online safety reporting for Medical Devices

Following pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) has mandated that manufacturers of medical devices and in-vitro devices submit their safety reports online.

The Drugs Controller General of India, has issued the directive on 19th March 2024 for online submission of Period Safety Update Reports for Medical Devices and in-vitro devices, aimed at improving post-market surveillance data evaluation

Effective 1 April 2024, the option to submit applications offline in hard copy or any other method will no longer be available

A PSUR is a vital pharmacovigilance document that assesses the risk-benefit balance of a drug product after its authorization, providing a comprehensive analysis based on all available information, including new data.
This report determines whether additional studies are necessary or if modifications are needed

This is part of efforts to overhaul India’s drug regulation framework and enhance safety transparency.

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Latest-Circulars/
https://www.livemint.com/

Awareness Program – GCPPCS

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Awareness programme on
Good Clinical Practice Professional Certification Scheme (GCPPCS)

Translational Health Sciences and Technology Institute (THSTI), an autonomous institution under the Department of Biotechnology, Ministry of Science and Technology, Government of India announces the rollout of the Good Clinical Practice Professional Certification Scheme (GCPPCS) awareness webinar series.

Good Clinical Practice Professional Certification Scheme (GCPPCS) is first of its kind based on the International Personnel Certification Standard (ISO 17024:2012). GCPPCS is aimed to achieve an uniform, competence standard using internationally accepted best practice for assessment and certification.

GCPPCS has two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and certification (by Third-Party Certification) to promote certification of GCP professionals both within the country and across the globe.

There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. THSTI as the Scheme Owner believes that GCPPCS will help in achieving a benchmark in the competence requirements.

When?

Date : March 21,2024
Time : 3pm to 5 pm IST


Who Should Attend?

All Interested professionals – ethics committee members, clinical researchers or clinical trial team members, investigators involved in clinical research or trial, personnel working in the area of regulatory affairs, pharma, biotech, research institutes, academia, and other personnel working in this area can register for the webinar

The registered participants will receive e-Certificates (Certificate of attendance)


Fee ?

There is NO Fee for attending this webinar


Last Date for Registration is March 20,2024 till 6 pm IST


The link to register online : https://forms.gle/SHe6qDusSnDfScDC7


For any queries please contact : gcppcs.cdsa@thsti.res.in

Source: https://cdsa.thsti.in/gcppcs-accreditation/

Clinlab India 2024 Conference – Industry Update

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CLIN LAB INDIA 2024 CONFERENCE @Mumbai on
14th March 2024

MEDICAL FAIR INDIA is India’s leading Trade Fair for the Medical and Healthcare Industry. For the last 28 years, Medical Fair India has been successfully addressing the various needs of Hospitals, Health Centres & Clinics.  With participation from over 20 countries, MEDICAL FAIR INDIA provides an opportunity to position your brand among competitors and further increase your level of visibility. MEDICAL FAIR INDIA acts as a platform where connections are made and business relationships are nurtured.

ClinLab India is the exhibition & conference on the topic of laboratory medicine, Point of Care Testing, molecular diagnostics and clinical chemistry. The show is aimed to promote the recent developments and market trends in the in-vitro diagnostics (IVD) sector and allied areas.

ClinLab India brings together the leaders in the medical laboratory industry designed to create maximum interaction and meeting opportunities where manufacturers, dealers and distributors can promote their brands, meet potential customers and entertain existing clients. 

The year 2024 holds a lot of promise for the Indian IVD industry. Technology is also going to be a critical growth factor. The Indian start-up ecosystem is aggressively targeting the IVD-MedTech segment, and we will see some compelling solutions from them soon

This is the 5th Edition of ClinLab India.

Conference Theme 2024 :
Driving Global Dominance through Innovations :
– IVD Industry’s Role in Economic Growth

𝗪𝗵𝗲𝗻 ?
📅 Date: 14th March 2024 – Thursday
⏲ Time: 10 00 am – 5 00 pm
🌆 Venue: Bombay Exhibition Centre, Mumbai

𝗪𝗵𝗼 𝗦𝗵𝗼𝘂𝗹𝗱 𝗔𝘁𝘁𝗲𝗻𝗱 ?

IVD , Biotech companies – Management & Technical Personnel, Healthcare Services – Management & Technical Teams from Clinical Labs/Hospitals/Blood Banks/CROs/Medical Colleges/Home Healthcare Companies and Other Healthcare Organisations , Startups, Innovators from Biotech space, Other stakeholders, Government Representatives

𝐅𝐨𝐫 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐔𝐩𝐝𝐚𝐭𝐞𝐬, please visit :

https://www.medicalfair-india.com/special-shows-clin-lab-india

Download Clinlab Conference Brochure
Download Clinlab Conference Agenda

Conference Entry by Prior Registration.

Delegate Fee : INR 1100 per participant (including GST). Fee includes Lunch & Hi Tea

𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 :

𝗦𝘁𝗲𝗽 𝟭 :

Make the payment using the QR code shared below

Step 2:
Click the ‘Register here” button given below and fill up the delegate registration form. Please mention the payment reference number in the form 

Register here

For more information about Expo, visit : https://www.medicalfair-india.com

For enquiries related to Conference Partnerships, Stalls booking inside Diagnostics Pavilion , delegate registration enquiries, pls write to :

VermaA@md-india.com / +91-124-4544507
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

For conference delegate registration enquiries, please write to :
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

Source: https://events.healthcare/

Regulatory Guidelines for Sampling of Drugs

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REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES

Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices vide their circular dated 9th feb 2024.

This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc.

This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.

The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:

 Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.
 Ensuring that existing control methods are satisfactory.
 Investigating the Not of Standard Quality (NSQ) Product.
 Identifying Unapproved Products/ Without License sales outlets.
 Identifying Spurious drugs in distribution chain
 Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Home/

Industry Update – Program by KIHT

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International Fellowship on Health technology assessment by
KIHT,Visakhapatnam

The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments.

KIHT aims to equip participants with the latest methodologies, best practices, and insights in HTA, empowering them to become leaders in the field.

The 9th International Fellowship on Health Technology is scheduled on 18th to 24th March 2024 at Kalam Convention Center,AMTZ Campus, Visakhapatnam

Program Details are given below:

Date   :  18 – 24 March 2024
Time  :   9.30 am to 5.30 pm
Venue:   Kalam Convention Center C/o AMTZ Campus, Visakhapatnam,Andhra Pradesh- 530031

Program Benefits :

– Conceptual Mastery in HEOR
– Exclusive Insights into Emerging Trends in HEOR
– Proficiency in cutting edge HEOR software
– Access to exclusive Research and Training materials
– Practical knowledge in Study design, Evidence synthesis and Economic modelling
– Exposure to Real world evidence, case studies and applications
– Open discussion with Academicians and Industrial Leaders
– Benefits of mentorship from World renowned Professionals in the field
– Global Networking Precision

Who should attend?

– Healthcare Policy makers and Regulators
– Medical Professionals and Practitioners
– Health Economist and Researchers
– Healthcare Industry and Innovators
– Academicians and Students
– Hospital Administrators

For Fee and other queries: Visit: https://kiht.in/

Contact:
Ms. Kaviya Jeyaram
kaviya.j@kiht.in
+91 8220025552

Mr. Nitturi Naresh Kumar
n.nareshkumar@ibsc-amtz.in
+91 8897330990

Click here to view Agenda

source :https://kiht.in/

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices

The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820). This new rule aims to:

Harmonize with international standards, specifically the ISO 13485:2016 standard for medical device quality management systems. This will streamline processes for manufacturers who export to other countries.

Modernize the requirements, reflecting best practices in quality management and aligning with current technologies and approaches.

Increase flexibility for manufacturers, allowing them to tailor their quality systems to their specific needs while still meeting essential safety and effectiveness requirements.

Key points of the QMSR:

Incorporation by reference of ISO 13485:2016: This means that manufacturers can largely follow the ISO standard to meet the FDA’s requirements, with some additional clarifications and modifications outlined in the QMSR.

Focus on risk management: The QMSR emphasizes a proactive approach to identifying and mitigating potential risks throughout the product lifecycle.

Quality by design: The QMSR encourages manufacturers to build quality into their products from the start, rather than relying on inspections and testing to catch problems later.

Increased transparency: The QMSR requires manufacturers to maintain more comprehensive documentation and make certain information available to the FDA upon request.

Important dates:

Publication date: January 31, 2024

Effective date: February 2, 2026

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

Source: https://www.fda.gov/

AMD – CF schemes for Medical Device Clusters

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Assistance to Medical Device Clusters for Common Facilities (AMD-CF)

The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore

About AMD-CF Scheme

AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector

The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time

The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of 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

The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.

SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

Components / Sub schemes of AMD – CF Scheme

There are two components / sub schemes to this AMD – CF scheme :

1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.
2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices

Financial outlay of the Schemes :

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 for the common facilities and Rs. 60 crore for the testing facilities

Tenure of the Scheme :

The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.

Incentives Under this Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.

In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.

Any expenditure above the prescribed limit shall be borne by the elected applicant

Benefits of the Sub Schemes are :

i. Improvement in quality standards of medical devices
ii. Improvement in regulatory compliance specified for medical device
iii.Increased availability of trained personnel for Medical Devices clusters
iv.Increased competitiveness of Medical Devices units in cluster
v. Reduction in the manufacturing cost of Medical Devices

Notice for Invitation of Applications:

The Department has now invited applications from eligible applicants under the Scheme AMDCF.

The eligible applicants may apply through online mode only. The link is https://amdcf.udyamimitra.in/.

The detailed guidelines of the Scheme is available at https://pharmaceuticals.gov.in/schemes.

The last date for filing of the application is 10.02.2024.

Click here to read the AMD-CF Guidelines

NSW portal for Medical Devices

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Launch of NSW Portal for Medical Devices

Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation,  examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

All the stakeholders should submit the application for the above 3 activities, through NSWS portal only

Click the link below to read the detailed guide book on How to apply for CDSCO approval

Guide book on How to apply for CDSCO approval

Source:https://cdsco.gov.in/opencms/opencms/en/Home/

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