Medical Device Regulatory Glossary

A premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

The Brazilian Health Regulatory Agency responsible for health product regulation, including medical devices, pharmaceuticals, and food safety.

A Brazilian legal entity required to hold medical device registrations on behalf of foreign manufacturers with ANVISA.

The FDA center responsible for regulating medical devices and radiation-emitting products in the United States.

A mandatory conformity marking for medical devices sold in the European Economic Area, indicating compliance with EU health, safety, and environmental requirements.

The Mexican Federal Commission for Protection Against Health Risks, responsible for regulating medical devices, pharmaceuticals, and food safety in Mexico.

An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no predicate device for 510(k) comparison.

A compilation of records describing the design history of a finished medical device, required by FDA 21 CFR Part 820.

A legal entity established in the European Union appointed by a non-EU manufacturer to act on their behalf for regulatory matters under EU MDR.

The European Union Medical Device Regulation (2017/745) that governs the approval, manufacturing, and post-market surveillance of medical devices in the EU.

The U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and other products.

A system of regulations, codes, and guidelines ensuring medical devices are consistently produced and controlled according to quality standards.

The international standard for quality management systems specific to medical device organizations.

A medical device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening purposes.

China's national regulatory authority for drugs, medical devices, and cosmetics, formerly known as CFDA.

An organization designated by an EU Member State to assess the conformity of medical devices before they are placed on the market.

The FDA's most rigorous device marketing pathway, required for high-risk Class III medical devices to demonstrate safety and effectiveness.

Japan's regulatory agency responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices.

A formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives in medical device manufacturing.

A system to uniquely identify medical devices through distribution and use, using a standardized identifier on device labels and packages.