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

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

BSI Launch Event: Antimicrobial Resistance (AMR) certification

BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)

According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled

BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.

  • Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing 
  • Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
  • Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust

Who should attend?

  • Pharmaceutical manufacturers
  • Regulators
  • Government policy makers
  • Trade associations
  • Contract manufacturers
  • Hospital / healthcare systems sustainability procurement

Workshop on Pharmacovigilance

Workshop –Cum-Training program on Pharmacovigilance

Indian Pharmacopoeia Commission is organising a Workshop cum Training Programme on Pharmacovigilance for NABH Accredited Hospitals on Monday, July 11, 2022 between 9 am to 1 pm at Shekhar Hospital, Uttarpradesh

Total seats: 50, Registration will be accepted based on first come first serve basis.

Registration fee is Rs.1180 inclusive of GST. Last date for registration is July 6 2022.