Spanish Agency for Medicines and Health Products
The Spanish Agency for Medicines and Medical Devices of Spain is a state-owned company attached to the Ministry of Health, Social Services and Equality. It is responsible for guaranteeing society, as a public service, the quality, safety, efficacy and correct information of medicines and medical devices. From the research phase to its use, the AEMPS protects and promotes the health of people, animals and the environment.
The AEMPS has a Notified Body (0318), so it also acts as an auditing body in relation to the requirements of products and medicines.
Among its activities, the following stand out in relation to the medical device:
- Authorisation of clinical investigations of medical devices.
- Certification, control and surveillance of medical devices.
- Fight against illegal or falsified medical devices.
- Drafting of national medical device legislation .
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