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).
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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.
Webinar – MoCRA: Product Listing & Facility Registration
Book your spot for our new live webinar about Product Listing & Facility Registration in the US market, on October 10th
MoCRA Facility Registration Requirements
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).
Understanding MoCRA: how to obtain a safety substantiation in the US
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).
From FDA facility registration to US Agent: MoCRA step-by-step for the European cosmetic industry
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).
EU Regulations on Medical Devices and IVD medical devices: What is the mandate and when do manufacturers need it?
Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). Read more!