Global Regulatory Resource

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

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

By |2019-09-07T01:17:51+00:00September 7th, 2019|Global Regulatory Resource|0 Comments

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

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

By |2019-09-12T16:49:43+00:00May 5th, 2017|Global Regulatory Resource|0 Comments

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

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

By |2019-09-12T16:39:17+00:00December 9th, 2016|Global Regulatory Resource|0 Comments