Product Conformity Assessment definition
Product Conformity Assessment. The process demonstrating whether the requirements of Regulation (EU) 2017/745 relating to a device have been fulfilled. Control of product conformity with the conditions provided in the Regulation (EU) 2017/745 by means of application review, documentation reviews, Technical Documentation reviews, audits, evaluation, decision and similar activities. Medical Device Single Audit Programme (MDSAP): A single regulatory audit of a medical device manufacturer conducted by recognized Auditing Organization (AO) to meet the requirements of the following regulatory authorities (RAs): Australia’s Therapeutic Goods Administration (TGA), Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), U.S. Food and Drug Administration (USFDA) Regulatory Authority (RA): A government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements Authorities Responsible for Notified Bodies: The authorities in charge of assigning/designating Notified Bodies (ZLG in Germany.) Competent Authority: Regulatory authority of the country responsible for medical devices. Competent Higher Federal Authority (The Federal Institute for Drugs and Medical Devices (BfArM)) listed in the ▇▇▇▇▇://▇▇▇.▇▇▇▇▇.▇▇ web site based on their scope of coverage in Germany for MDR).