Medical Device Regulations Database

Terminologies for Categorized Adverse Event Reporting (AER)

Standardized terminologies, terms, and codes for categorized adverse event reporting. Enables harmonized global vigilance data exchange.

Medical Device Sanitary Control and Import Procedures

Requirements for import licenses, customs clearance, and regulatory compliance for medical devices imported into Brazil.

Software-Specific Risk Characterization for Medical Device Software

Characterization considerations for medical device software and software-specific risk assessment. Covers intended purpose, algorithm design, and clinical context.

Good Machine Learning Practice (GMLP) for Medical Device Development

Guiding principles for good machine learning practice in medical device development. Addresses AI/ML lifecycle, data quality, and validation.

Medical Device Regularization and Compliance

Requirements for medical device regularization, quality management, technical documentation, and post-market surveillance.

Common Data Set for Adverse Event Data Exchange Between Regulators

Common data set specification for adverse event data exchange between IMDRF regulatory authorities. Enables standardized vigilance information sharing.

In Vitro Diagnostic (IVD) Medical Devices

Regulation for IVD medical devices including classification (Class I-IV), registration pathways, self-testing requirements, and companion diagnostics. Replaced RDC 36/2015.

Non-IVD Medical Device Regulatory Submission Table of Contents

Standardized table of contents for non-IVD medical device regulatory submissions. Edition 4 with updated structure for global harmonization.

IVD Medical Device Regulatory Submission Table of Contents

Standardized table of contents for IVD medical device regulatory submissions. Edition 4 with updated structure for global harmonization.

Assessment and Decision Process for CAB Recognition

Assessment and decision process for recognition of conformity assessment bodies conducting medical device regulatory reviews.