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The use of GMDN codes for IVD medical devices in Australia
Global Medical Device Nomenclature (GMDN) The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices: 1 • consistent assessment of devices before they are approved for supply . GMDN codes are used to
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Australian Public Assessment Report for Silodosin
www.tga.gov.auAustralian Public Assessment Report for Silodosin Proprietary Product Name: Urorec ... • To report a problem with a medicine or medical device, please see the information on ... //www.tga.gov.au>. About AusPARs • An Australian Public Assessment Re port (AusPAR) provides information about the evaluation of a prescription medicine and the ...
Guideline for the labelling of medicines
www.tga.gov.auGuideline for the labelling medicines of istorical consultation document Draft - Version 1.0, August 2014
Australian public assessment report for Linagliptin
www.tga.gov.au• An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
Guidance 18: Impurities in drug substances and …
www.tga.gov.auTherapeutic Goods Administration Guidance 18: Impurities in drug substances and drug products V1.0 August 2013 Page 3 of 13 Version history Version Description of change Author Effective date
Explanatory notes for pharmaceutical manufacturers on the ...
www.tga.gov.auPE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / …
COMIRNATY™ COVID-19 VACCINE
www.tga.gov.auDo not receive this vaccine if you are allergic to any of these ingredients. What COMIRNATY looks like COMIRNATY is a white to off-white suspension provided in a multidose clear glass vial. After dilution, each vial contains 6 doses of vaccine. AUST R 346290. Who distributes COMIRNATY Pfizer Australia Pty Ltd Sydney NSW www.pfizer.com.au
COVID-19 rapid antigen self-tests
www.tga.gov.auCOVID-19 rapid antigen self-tests. This guidance refe rs to COVID -19 (caused by SARS-CoV-2) only and does not include self-tests to detect other types of coronavirus , or COVID_19 rapid antibody tests . COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct a test and interpret the results by themselves.
AUSTRALIAN PRODUCT INFORMATION (ChAdOx1-S) …
www.tga.gov.auAUSTRALIAN PRODUCT INFORMATION COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection . 1 NAME OF THE MEDICINE . ChAdOx1-S (provisional ABN) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION . Each multi-dose vial contains 5x10. 11. viral particles (vp) of (ChAdOx1-S . a, b) in 5 mL. One dose (0.5 mL) contains 5x10. 10. vp of …
Australian public assessment report for BNT162b2 (mRNA)
www.tga.gov.auThe RNA is encapsulated in lipid nanoparticles (LNPs), which enables entry into host cells, expression of the S protein, and elicitation of both antibody and cellular immune responses. The vaccine is supplied as a white to off white sterile frozen liquid, packaged in a multi dose clear glass 2 mL vial with a rubber stopper,
PE009, the PIC/S guide to GMP for medicinal products
www.tga.gov.auPE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance V2.1 September 2020 Page 4 of 69 Authorised Person needs full overview of all manufacturing steps ----- 18. RFS includes consideration of marketing authorisation requirements ---- 18
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Unique Device Identification (UDI) - GMTA Global Medical ...
www.globalmedicaltechnologyalliance.orgharmonized unique device identification (UDI) system will positively impact many ... databases, such as the FDA’s Global Unique Device Identification Database (GUDID) ... Global Medical Device Nomenclature (GMDN): The GMDN is a system of internationally agreed terms used to identify medical devices. The GMDN database
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www.imdrf.orgThese two codes are intended to be used alongside the Global Medical Device Nomenclature (GMDN) to provide a fairly complete coded description of an adverse event.
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www.ahrmm.orgGlobal Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices of the same type (device types) used …
Global Medical Technology Alliance
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jyoungpharm.orgGlobal medical device nomenclature structure The general structure of the GMDN is regulated by requirements stipulated in the standard ISO 15225 Nomenclature – Medical device nomenclature data structure. Figure 1 shows the basic organization of the GMDN data. The data is defined by three levels, associated
Global Medical Device Nomenclature - Flinders University
www.flinders.edu.aumedical devices suitable for use by all interested parties globally. On the 1 st of November 2001 the Global Medical Device Nomenclature (GMDN) was published as
Global Medical Device Nomenclature - Ministry of Public …
elib.fda.moph.go.thGlobal Medical Device Nomenclature A Short Technical Introduction to the GMDN Version 2002 ... A number that represents a general medical device family to which the term has been assigned. All terms have a primary category; some also have secondary and tertiary categories. The numbers correspond to the category code.
Assessment of Peripheral Devices (RAPID) - MDEpiNet.org
mdepinet.org3 Executive Summary The Registry Assessment of Peripheral Interventional Devices (RAPID) project emerged from the Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of the Medical Device Epidemiology Network (MDEpiNet), a public‐ private partnership