Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
Art. 1 This Resolution defines the rules for risk classification of medical devices, the requirements for labeling and instructions for use, and the procedures for notification, registration, alteration, revalidation and cancellation of notification or registration of medical devices.
The description of all classification rules can be obtained in Annex I.
(amended by RDC No 777 of 2023:01-MAR-2023)
Amendment of RDC No.751:2022
ANVISA RDC No. 665 of 30-MAR-2022
Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.
Article 1. This regulation provides for the Good Manufacturing Practices (GMP) for Medical Products and In Vitro Diagnostic Products, establishing the requirements that describe the GMP for methods and controls used in the design, purchasing, manufacturing, packaging, labeling, storage, distribution, installation, and technical assistance applicable to the manufacture of medical products and in vitrodiagnostic products.
Article 2. This regulation applies to manufacturers, distributors, storers, and importers of medical products and in vitro diagnostic products that are commercialized in Brazil.
Definitions:
II - quality audit: an established, systematic, and independent examination of a manufacturer's entire quality system, performed at regular intervals and with sufficient frequency to ensure that the quality system’s activities and its results comply with the procedures specified in its quality system.
This Resolution provides for inspection programs and establishes criteria for granting and renewing the Certification of Good Manufacturing Practices for Medical Devices - Risk Classes III and IV.