In this post, we will go through the information required for EUDAMED Registration and the rationale behind this system. The European Database on Medical Devices (EUDAMED) is an online platform aimed at placing all actors within the Medical Device industry, within EU onto the same platform. Actor, in this context, means any organization that needs …
Category Archives: MDR
Medical Device Regulations for Distributors & Importers
The Medical Device Regulations for Distributors came into force in mid-May 2021 (after being postponed by 1 year due to Covid-19). Through this regulation, the European Union has streamlined the various fragments of regulations of directives and regulations that previously existing. The idea behind this regulation is to define the level of standard for the …
Continue reading “Medical Device Regulations for Distributors & Importers”
Good Distribution Practise (GDP) Certification in Malta
GDP Certification in Malta refers to the minimum standard that distributors of wholesale products must meet to ensure that good quality medicines are maintained throughout the supply chain. Unlike an ISO certification, GDP is a mandatory requirement for companies involved in the wholesale, or distribution of medicinal products. Even more so, now with the introduction …
Continue reading “Good Distribution Practise (GDP) Certification in Malta”