Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
RDC 830/2023
Art. 1 This Resolution provides for risk classification, notification and registration regimes, labeling requirements and instructions for use and procedures for notification, registration, amendment, revalidation and cancellation of notification or registration of medical devices for diagnosis in vitro, including its instruments.
Content:
CHAPTER I - INITIAL PROVISIONS (Definitions)
CHAPTER II - RISK CLASSIFICATION OF MEDICAL DEVICES FOR IN VITRO DIAGNOSIS
CHAPTER III - NOTIFICATION OR REGISTRATION REQUEST AND ITS MAINTENANCE
CHAPTER IV - ADMINISTRATIVE SANCTIONS
CHAPTER V - REQUEST INFORMATION FORMS AND YOUR MEDICAL DEVICES FOR IN VITRO DIAGNOSIS
CHAPTER VI - LABELS AND INSTRUCTIONS FOR USE OF MEDICAL DEVICES FOR IN VITRO DIAGNOSIS
CHAPTER VII - TECHNICAL DOSSIER
CHAPTER VIII - FINAL AND TRANSITIONAL PROVISIONS
ANNEX I - RISK CLASSIFICATION RULES FOR MEDICAL DEVICES FOR IN VITRO DIAGNOSIS
ANNEX II - STRUCTURE OF TECHNICAL DOSSIER OF MEDICAL DEVICES FOR IN VITRO DIAGNOSIS SUBJECT TO NOTIFICATION AND REGISTRATION WITH ANVISA
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.
Resolution - RE No. 392 of 20/02/2018
Recognizes the Medical Device Single Audit Program (MDSAP) to support health inspection and inspection actions.
Art.2, §2 Medical devices for in vitro diagnosis (instruments) used or reconditioned are dealt with in the Collegiate Board Resolution - RDC nº 579, of November 25, 2021.
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
ANVISA Comment on the new resolution RDC 830/2023:...