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New HIN Authorized Licensee: Bendcare

To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]

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Singapore designates HIBCC as UDI Issuing Agency

Singapore’s Health Sciences Authority (HSA) has designated HIBCC as an Issuing Agency for its Unique Device Identification (UDI) System Regulation. HSA’s UDI regulation adopts the globally recognized principles established by the International Medical Device Regulators Forum (IMDRF), which closely aligns with both the United States (US) Food and Drug Administration’s (FDA) and the European Commission’s […]

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New HIN Authorized Licensee: United Rheumatology, LLC, a division of Specialty Networks, LLC & Chiesi USA, Inc.

To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]

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New HIN Authorized Licensee: Helio Argos

To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]

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The UK plans to designate HIBCC as an Issuing Entity in its upcoming UDI Regulation 

Yesterday (6/26/22), the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published its official response to the Future Regulation of Medical Devices Consultation (initially launched in 2021). The consultation included a substantial section on the implementation of UDI. An overwhelming number of respondents expressed the need for consistency among existing and future UDI […]

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Register now for our HIBCC UDI Webinar

Review the US UDI requirements ahead of the September 2022 deadline for Class I devices. To register for the HIBCC UDI Webinar: FDA UDI Labeling and GUDID Submission Requirements click here. HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more […]

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New HIN Authorized Licensee: Onco360

To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]

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New HIN Authorized Licensee: Vifor Pharma, Inc. & Granules Pharmaceuticals, Inc.

To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]