Device Licensing SOP Overview

Compass Health Al SOP: Device Licensing

• This SOP outlines the system and instructions for device licensing activities.
• The SOP covers responsibilities for Quality Management System (QMS) certification submission and classification activities for Canada, Australia, and the United States.
• The procedure applies to all Class I, Class Ila, and Class II medical devices manufactured by Compass Health.

Approvals

• The document was authored by Tenzin Yangzom.
• The document was approved by James Baskin.
• The date of approval was January 2, 2024, and January 3, 2024.

Revision History

• Version 1.0 was released on January 3rd, 2024.
• This is an initial release.

Introduction

• This procedure provides a system and instructions for device licensing activities.
• Responsibilities are assigned for implementation.
• Activities include quality management system (QMS) certificate submission, and classification for Canada (Health Canada's Canadian Medical Device Regulations), Australia (TGA's Medical Device Regulation) and the United States (FDA).

Scope

• The SOP applies to all Class I, Class Ila and Class II medical devices produced by Compass Health, authorized for sale in Canada and the USA.
• It also covers all Compass Health QMS (Quality Management System) documents and information related to those devices.
• Currently Compass Health does not plan to manufacture or sell medical devices beyond Classes I, Ila, and II, but the SOP can be adjusted if that changes.

Applicable Standards

• Canadian Medical Device Regulations (CMDR)
• The US Food and Drug Administration (FDA) Medical Device Regulation
• Australian Therapeutic Goods (Medical Devices) Regulations 2002

Reference Documents

• SOP: Labeling and Packaging

Acronyms and Definitions

• RA: Regulatory Affairs
• QMS: Quality Management System
• QA: Quality Assurance
• FDA: Federal Drug Administration
• CFR: Code of Federal Regulations

Definitions

• Canadian Medical Devices Regulations (CMDR): The Canadian rules and regulations that medical devices and manufacturers must follow in Canada.

• Medical Device Single Audit Program (MDSAP): A program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that meets the requirements of multiple regulatory jurisdictions.

• Active Device: A medical device that relies on a source of energy other than the human body or gravity for operation. This includes supplying or withdrawing energy from a patient.

• Active Diagnostic Device: An active device used for providing information to detect, monitor or treat physiological conditions.

• Active Therapeutic Device: An active device used for supporting, modifying, replacing or restoring a biological function for treating illnesses or injuries.

• Body Orifice: Natural or artificial openings of the body.

• Closed-loop System: A system that enables a medical device to sense, interpret, and treat.

• Invasive Device: A medical device intended to come into contact with the eye or penetrate the body.

• Medical Device: An article, instrument, apparatus, or accessory used to diagnose, treat, mitigate, prevent or modify disease, disorders or physiological states in humans, pregnancy. These do not include veterinary products or drugs.

• Licence Renewal (MDL): Process for obtaining a medical device license, which needs to occur annually.

• Annual Review (MDEL): Annual review process to submit an application for review by the Minister of Health.

• Regulatory Correspondent: Authorized representative on behalf of the manufacturer.

Device Licensing Process by Regulatory Jurisdiction

• Class I: Low risk devices - No license in Canada or USA.
• Classification based on regulatory standards.
• In Canada, manufacturers need a medical device license (MDEL) for Class II, III, and IV devices. Class I devices do not require one, but manufacturers still need a medical device establishment license (MDEL).
• Compass Health processes for medical device licenses annually.

Annual Review

• Compass Health must submit an application and pay their annual fee before April 1st.
• If there are additions, these need to be added in the next application.
• No application is required for beginning new tasks or adding devices in any classes.
• Compass Health will notify Health Canada if they stop manufacturing Class I devices.

Medical Device License

• QA/RA will fill out the necessary application forms for the license.

Renewal (Medical Device Licence)

• Annual renewal of medical device licenses is required.
• Fee payment must be completed before November 1st.

Discontinuation of a Medical Device's Sale

• QA/RA needs to inform the Minister of Health within 30 days if Compass Health has stopped selling a device.
• This procedure does not cover Class III & IV devices; however, if Compass Health sells these devices it will need to be updated accordingly.

USA Regulation

• Compass Health must comply with FDA regulations and submit appropriate applications for their product/medical devices in the USA, including 510(k) for Class II devices.
• A medical device registrar will represent Compass Health in the United States.

Australia Regulation

• Compass Health can utilize an abridgement process for Australian conformity assessments if there are similar medical device licenses in Canada, and meet certain conditions.
• Manufacturers must notify their auditing organization about proposed changes to the QMS (Quality Management System), critical suppliers, manufacturing processes, the kind of medical devices allowed, and other changes relevant to quality management.

QMS Certificate Requirements (Canada)

• If there are changes in the QMS, a copy must be sent to Health Canada within 30 days of its issuance.
• Substantial changes require notification to the TGA.

Investigational Devices

Evidence of Compliance

• Compass Health must be able to provide evidence of compliance with the Canadian regulatory requirements (CMDR) if a device is sold in Canada.
• The Compass Health Quality System (QMS) is augmented to meet Canadian requirements for safety and effectiveness of medical devices.

Change Notifications to Regulatory Agencies

• Changes to designs and manufacturing needs to be assessed for potential impact on licenses.
• Compass Health is required to adhere to specific safety and effectiveness requirements and standards for products.

Canada Changes

• Changes are reviewed to determine if changes are considered major or significant when a device's regulatory status changes (e.g., class, manufacturer, name, etc.).
• Necessary notifications are made to Health Canada.

Australia Changes

• Changes are evaluated by auditing organizations to determine if a special audit is needed.
• Examples of substantial changes such as manufacturing facility changes, critical equipment, or manufacturing steps, may require notification to the TGA.

Process Monitoring

• QA/RA are responsible to remain connected to the device licensing process and ensure all regulations are observed.
• They are required to be aware of the latest changes and all relevant documents.

Quality Records

• Records must be maintained and kept updated based on the regulations of each country.
• A record of Health Canada and Australian licenses for different classes of devices are kept by Compass Health.
• Compass Health submits required certifications relating to safety and effectiveness of medical devices to the relevant governing bodies.

This SOP provides a detailed outline of the device licensing process for Compass Health, focusing on responsibilities and classifications for medical devices across Canada, Australia, and the United States. It covers Quality Management System (QMS) certification submission and outlines the protocol for Class I, Class IIa, and Class II devices.