Global Regulatory Resources2019-09-10T19:05:31+00:00

Global Regulatory Resources

European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)

By |September 7th, 2019|Categories: Global Regulatory Resource|

“…Regulation (EU) 2017/745 allows reprocessing of single-use devices only where [...]

European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:

By |May 5th, 2017|Categories: Global Regulatory Resource|

Single-Use Devices and their Reprocessing “…The reprocessing and further use [...]

South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)

By |December 9th, 2016|Categories: Global Regulatory Resource|

“…’manufacture’ means operations that include the design, purchasing of material, [...]

Germany, Commission on Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM), Hygiene Requirements for the Reprocessing of Medical Devices (2012)

By |December 1st, 2012|Categories: Global Regulatory Resource|