Medicinal Products And Medical Devices

The combination of medical devices and medicinal products …

https://omcmedical.com/borderline-classification-of-combination-of-medical-devices-and-medicinal-products/

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …

Products and Medical Procedures | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures

General Hospital Devices and Supplies. Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical …

Understanding the borderline between medical devices …

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/understanding-the-borderline-between-medical-devices-and-medicinal-products/

The Medical Device Coordination Group (MDCG) is composed of representatives of Member States and chaired by the EU Commission. The MDCG has …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device. Step 1: Determine if your product meets the …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices …

Quality documentation for medicinal products when used …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a …

HALMED - Agency for Medicinal Products and Medical Devices

https://www.halmed.hr/en/

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical …

Medicinal products & medical devices - admin.ch

https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel.html

The use of therapeutic products is regulated by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). It is designed primarily to …