PRA204 Regulatory Affairs Medical Device

This course on Medical Device Regulation will provide participants with an in-depth understanding of the regulatory requirements for medical devices.

The course will cover Medical Device Classification and Quality Management, including Quality Management Systems (QMS) and the International Organization for Standardization (ISO) standards.

The course will start with an overview of the Medical Device Classification system, which is used to categorize medical devices based on their level of risk to patients and users.

Participants will learn about the different categories of medical devices, from Class I to Class III, and the regulatory requirements for each category.

Participants will learn about the structure of the applicable ISO standard, and how it relates to the development, manufacturing, and distribution of medical devices.

They will also gain an understanding of the requirements for implementing a QMS in accordance with the standard.

The course will then cover the Medical Device Single Audit Program (MDSAP), which is used by regulatory agencies in multiple regions to conduct audits of medical device manufacturers.

Participants will learn about the structure of the MDSAP audit, including the audit criteria and scoring system.

The course will also cover labelling requirements for medical devices, including the various types of labelling, such as product labelling, packaging labelling, and patient labelling.

Participants will also learn about the requirements for medical device submissions, including the Common Technical Document (CTD) format.

Learning Points:

• Overview of medical devices
• Definition of medical devices IVDD and non-IVDD
• Licenses overview (diagram MEDL, MDL Class II, III, IV)
• Registries/national databases – Canada MDALL
• GMDN (Global Medical Device Nomenclature) Agency (US)
• Overview of medical devices products access (Canada vs. US)
• Medical devices classification
• Non-IVDD classification determination – Class I, II, III, IV
• IVDD classification determination – Class I, II, III, IV
• Drug/device combination determinations
• Comparison to USA
• Quality management system and ISO
• MDSAP: structure, audit criteria
• Labelling requirements
• Medical device application types and submissions

Throughout the course, case studies and examples will be used to illustrate key concepts and provide practical insights.

By the end of the course, participants will have a comprehensive understanding of the regulatory requirements for medical devices, including Medical Device Classification and Quality Management, MDSAP, labelling requirements, and the application submission process.