Medical Devices Interim Regulation

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions....

Medical Devices Interim Regulation - SFDA

https://sfda.gov.sa/sites/default/files/2019-10/MD-InterimRegulation-en_0.pdf

This Interim Regulation applies to the following parties and products: A. Manufacturers, authorized representatives, importers and distributors. B. All Medical Devices and …

Convenience Kits Interim Regulatory Guidance | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/convenience-kits-interim-regulatory-guidance

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May …

The European Union Medical Device Regulation – …

https://eumdr.com/

The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission …

MEDICAL DEVICES INTERIM REGULATION

https://alshedwygp.com/wp-content/uploads/2012/11/MDIR-en-2011.pdf

INTERIM REGULATION CHAPTER SIX Medical Devices Marketing Authorisation Article Eighteen A. The manufacturer or its authorized representative shall for the …

New transition regulations for the Interim Order …

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/transition-regulations-interim-order-notice.html

When the transition regulations come into effect, active authorizations granted for Class II, III and IV devices would be deemed medical device licences under …

Interim Order No. 3 Respecting the Importation and Sale …

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/interim-order-3-import-sale-medical-devices.html

1 (1) The following definitions apply in this Interim Order. COVID-19 medical device means a medical device that is manufactured, sold or represented for use in …

Saudi Arabia Medical Device Interim Regulations Update

https://www.bsigroup.com/en-AE/About-BSI/Media-Center/press-releases/2011/6/Saudi-Arabia-Medical-Device-Interim-Regulations-Update/

The recently introduced Medical Device Interim Regulations has made Saudi Arabia a regulated market for all types of medical devices. All manufacturers wishing to supply a …

الأنظمة واللوائح | Saudi Food and Drug Authority - SFDA

https://www.sfda.gov.sa/en/regulations

Regulations Exceptions List Click Here. 2022-12-26. Medical Devices Requirement. Requirements for Clinical Trials of Medical Devices (MDS-REQ 2) 2022-11 …