Classify Your Medical Device | FDA

Medical devices are assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes are: Class I (General...

Medical Device Regulation Act

No individual who is in the regular full-time employment of the United States and engaged in the administration of this Act may be a member of any medical device classification panel....

Product Classification

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Medical Devices - Sector - European Commission

Overview · Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions… ; Directives · The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... ; New Regulations · The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.

Vietnam Medical Device Classification | Asia Actual LLC

Asia Actual's Ho Chi Minh office is staffed with experienced, bi-lingual professionals that help medical device companies asses their device's classification.

Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) | FDA

Update: January 31, 2024 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulat...

Guidance - MDCG endorsed documents and other guidance - European Commission

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017…

Class I and Class II Device Exemptions | FDA

On this page: 510(k) Exemptions · Cures Act Exemptions · Quality System Regulation/Good Manufacturing Practices Exemptions

Medical Device Classifications and Applicable Food and Drug Administration Regulations | ICON plc

Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market.

HSA | Risk classification of medical devices

Understand the general risk classification system for medical devices, as well as the rules and factors that determine risk class.