Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 20
19Jul 2024
Canada, FDA, USA Cubicdesignz

eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission...
Read More
Cosmetic Regulatory Requirements in Italy
19Jul 2024
Cosmetics admin

Cosmetic Regulatory Requirements in Italy

Italy adheres to the EU regulation (Regulation (EC) No 1223/2009). The Italian Ministry of Health oversees the regulation of cosmetic products in the country. Italian Ministry of Health In Italy, the oversight and enforcement of cosmetic regulations are managed by the Italian Ministry of Health (Ministero della Salute). This authority works in collaboration with the Istituto Superiore di Sanità (ISS), the national institute of health, to ensure compliance with EU regulations and to address spec...
Read More
Cosmetic Regulatory
18Jul 2024
Cosmetics admin

Cosmetic Regulatory Requirements in Poland

Poland regulates cosmetic products under the framework of the European Union (EU) legislation, specifically adhering to Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetics placed on the market within the EU, including Poland. Key Aspects of Cosmetic Regulatory Requirements in Poland Chief Sanitary Inspectorate (GIS) In Poland, the regulatory authority responsible for overseeing compliance with cosmetic regulations is the Chief Sanitar...
Read More
17Jul 2024
Cosmetics, EU Cubicdesignz

Understanding Borderline Cosmetics in the EU

Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market. Dif...
Read More
IVDD
16Jul 2024
News, EU, IVD admin

EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers

On July 9, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) and took effect immediately. This new regulation aims to address the expected shortages of in vitro diagnostic medical devices (IVDs) in the EU due to the slower-than-expected transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR).  Following the removal of the sell-off provisions in Article 110.4, made official with Regulation (EU) 202...
Read More
13Jul 2024
Regulations, Swiss Cubicdesignz

Implant Card for Switzerland

Implant Cards in Switzerland For implantable products, the manufacturer must provide the product information required under Article 16 of MedDO, the information required under Article 18 paragraph 1 EU-MDR and must include the implant card. In Switzerland, the implant card must be in all three official languages of Switzerland. The information regarding implant card is in MedDO Article 20 Information on implantable devices. Healthcare institutions must enter the details of the implant...
Read More
13Jul 2024
Swiss, Select Swiss AR Swiss AR Cubicdesignz

What makes Switzerland significant for Medical Device Manufacturers?

Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders. The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision cluste...
Read More
News July 13, 2024 Cubicdesignz

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021 Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence...
Read More
News July 13, 2024 Cubicdesignz

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...
Read More
News July 13, 2024 Cubicdesignz

November Newsletter

EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. Such i...
Read More

Enquiry Now

    This will close in 0 seconds