The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
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Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Main regulatory developments to follow in 2024
Find out the 2024 updates regarding Medical devices, In-Vitro diagnostics, cosmetics, construction products, toys and more!
Compliance Success Stories: Home and Body Company – Building Trust Through Compliance for International Expansion
Explore Home and Body Co’s exceptional path through cosmetic compliance and how their partnership with Obelis Regulatory Services enabled international growth while maintaining a strong focus on product safety and regulatory excellence.
New Free Sales Certificate under MDR & IVDR for EU non-EU manufacturers!
The Belgian competent authority (AFMPS/FAGG) has updated the form for the Free Sales Certificates (FSC) under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).
MoCRA terminology: an insight into the main terms of the new American law on cosmetics
Learn the main terms of the new American law on cosmetics: MoCRA.
Contract manufacturers and brand owners: what has changed with MoCRA
MoCRA has ushered in significant changes for cosmetic brand owners and contract manufacturers, necessitating the revision of agreements and the establishment of clear responsibilities to meet the new regulatory standards.
What do EU cosmetic producers need to enter the US market?
Discover the path to US cosmetic market success with Obelis USA as your trusted partner. From FDA registration to regulatory compliance, we’ve got you covered.
Facility registration under MoCRA: who has to register and how to do it
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Good manufacturing practices (GMP) for cosmetic producers explained
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).