Slovenia Medical Device Regulations

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Registration of medical devices – JAZMP

https://www.jazmp.si/en/medical-devices/registration-of-medical-devices/

Registration of medical devices. The JAZMP maintains the Register of medical devices of manufactures, or their representatives established in the Republic of Slovenia, of devices in accordance with the Council Directive 93/42/EEC, Council Directive …

Legislation – JAZMP

https://www.jazmp.si/en/medical-devices/general-information-on-medical-devices/legislation/

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for …

Slovenia Medical Device Registration - JAZMP Approval …

https://arazygroup.com/medical-device-registration-slovenia/

In Slovenia, devices are regulated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). CLASSIFICATION SYSTEM: …

Slovenia - Medical Equipment - International Trade …

https://www.trade.gov/country-commercial-guides/slovenia-medical-equipment-0

Slovenia Implements New Packaging …

https://www.regdesk.co/slovenia-packaging-requirements/

Slovenia Implements New Packaging Requirements. Dec 3, 2019. The new regulation adopted in Slovenia implements …

Medical Device Registration in Slovenia - omcmedical.com

https://omcmedical.com/medical-device-registration-in-slovenia/

Medical Device Regulation EU MDR 2017/745 Medical Devices Act (No. 98/09) Official Language Slovene Classification Class I, IIa, IIb and III Registration Process Determine …

Medical Device Registration in Slovenia - elsmar.com

https://elsmar.com/elsmarqualityforum/threads/medical-device-registration-in-slovenia.65203/

"Pursuant to the Medical Devices Act (Official Gazette of the Republic of Slovenia, No 98/09), medical devices must be notified for entry in the register only by: …

Pharmaceutical & medical device advertising regulation …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/slovenia

When advertising both medicines and medical devices to healthcare professionals, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised unless …

MDR Language Requirements in EU …

https://www.mastermindtranslations.co.uk/mdr-language-requirements-in-each-eu-member-state/

The new EU Medical Devices Regulation has introduced more stringent language requirements for medical devices sold in the EU market. In doing so, it has placed the responsibility on each EU …

Notification procedure of medical devices in Slovakia | ŠÚKL

https://www.sukl.sk/en/medical-devices/instructions/registration-notification-procedure-of-medical-devices-in-slovakia?page_id=1718

The manufacturer of medical devices class IIa, IIb and III, or authorized representative, who under his own name places medical devices on the market and/or puts them into service …

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