regulatory framework – Pharma Consulting https://pharmaconsulting.pbt.com.bo Consultoría Regulatoria Inteligente Wed, 02 Oct 2024 15:19:38 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 IMDRF management comittee announces DIGEMID (Peru) as new affiliate member https://pharmaconsulting.pbt.com.bo/imdrf-management-comittee-announces-digemid-peru-as-new-affiliate-member/ Wed, 02 Oct 2024 15:19:38 +0000 https://pharmaconsulting.pe/?p=3093

The General Directorate of Medicines, Supplies and Drugs (DIGEMID) of Peru was announced as new affiliate member at the 26th International Medical Device Regulators Forum (IMDRF) Management Comittee Session held in September, 2024 and hosted by the United States of America.

What's the IMDRF?

The International Medical Device Regulators Forum or IMDRF is a group of regulators from around the globe, united in the pursuit of international medical device regulatory convergence.

It’s the only international regulatory forum of its kind for medical devices. It promotes the exchange of knowledge and best practices, and develops technical documents to promote effective regulatory models for safe and performant medical devices.

IMDRF is proactive, addressing emerging challenges, and always putting public health and patient safety at the forefront. With four membership categories and a number of technical working groups, IMRDF is structured to foster collaboration. The management comittee consists of authorities from various regions overseeing the Forum’s strategies, policies and directions. Official observers contribute to oversight activities, including participation in closed sessions of the management committee.

As an Affiliate Member, our Regulatory Authority will participate in IMDRF by attending open meetings and continue using IMDRF documents in part or in whole as the basis for its own regulatory framework. From now on, DIGEMID may also participate in Open Working Groups. This Working Groups develop publicly available technical documents and informative material.

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