Product regulatory information
Volpara Scorecard, Volpara Analytics and Volpara Live are manufactured by Volpara Health Technologies Limited (VHT), of which Volpara Health, Inc. is a wholly owned subsidiary.
|Volpara Health Technologies Limited
|EU Authorized Representative
Emergo Europe B.V.
2514 AP The Hague
|Australian TGA Sponsor
AA-Med Pty Ltd,
Risk Identification and Mitigation
In order to meet quality requirements, our risk management procedures have been developed to conform to EN ISO 14971:2012 (including Annex ZA) and ISO 27001:2013. The instructions for use and caveats contained within are traceable to the residual risks identified in those procedures.
Volpara Health Technologies Limited’s quality management system has been certified as conforming to the requirements of ISO 13485:2016, Australia – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 4 – Product Quality Assurance Procedure; Canada – Medical Devices Regulations – Part 1 – SOR 98/282; Japan – MHLW Ministerial Ordinance 169, Article 4 to Article 68, PMD Act; USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D by BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA. The Volpara Health Technologies Limited quality assurance system also meets the requirements of 93/42/EEC, Annex II excluding section 4 as assessed by BSI Group The Netherlands B.V. (Notified Body 2797), Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands.
Current global regulatory clearances for Volpara Health products
|Agency||Food and Drug Administration (FDA)||Health Canada (HC)||Dutch Health and Youth Care Inspectorate||Therapeutic Goods Agency (TGA)||Medsafe|
|Register||Establishment & Device Listing database||Medical Devices Active Licence Listing (MDALL)||Dutch Health and Youth Care Inspectorate via Notified Body||Australian Register of Therapeutic Goods (ARTG)||Web Assisted Notification of Devices (WAND)1|
|Listed entity||VHT Limited||VHT Limited||VHT Limited||VHT Limited||VHT Limited|
|Volpara Scorecard||Class II||Class II||Class Im||Class Im||Class Im|
|Volpara Analytics||Class I||Not a medical device||Not a medical device||Not a medical device||Not a medical device|
|Volpara Live||Class I||Class I||Class I||Class I||Class I|
Note: Volpara Health products may be available for sale in other regulatory jurisdictions. Please contact your Volpara Health representative for more information.
1. Beyond the need to register devices and report adverse events, there are no locally enforced regulatory requirements in New Zealand at this time.