Device Licensing SOP PDF

Compass Health AI SOP: Device Licensing Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin CO...

Compass Health AI SOP: Device Licensing Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document# QMS-SOP-0027 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-0027  1 Introduction The purpose of this procedure is to provide for a system and instructions – and to assign responsibilities for – the implementation of device licensing activities, Quality Management System (QMS) certificate submission and classification activities for Canada (under Health Canada’s Canadian Medical Device Regulations), Australia (under TGA’s Medical Device Regulation) and United States (under FDA). 1.1 Scope This procedure applies to all class I, Class IIa and class II medical devices (as classified by FDA, TGA and Health Canada respectively) manufactured by Compass Health that are authorized for sale in Canada and US and to all documents and information within the Compass Health QMS that reflect and support the marketing of Compass Health-made devices within the country. Note: Presently, Compass Health has no plans to manufacture and sell medical devices of a classification other than classes I, IIa and II. However, if Compass Health decides at a future date to expand its product line to include devices of a greater classification, this procedure shall be modified accordingly. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: Canadian Medical Device Regulations (CMDR-(SOR/98-282)) The US Food and Drug Administration (FDA) Medical Device Regulation Australian Therapeutic Goods (Medical Devices) Regulations 2002 Document# QMS-SOP-0027 Other references TGA guidance: Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion, November 2023 TGA guidance: Classification of medical devices that are not IVDs TGA guidance: Changes affecting TGA-issued conformity assessment certificates Essential Principles checklist: TG(MD)R Sch1 TGA Guidance: Substantial changes affecting a TGA conformity assessment certificate & Transfers of certificates TG(MD)R Sch3 P1 1.5(2) – changes to QMS 2.2 Reference Documents Document Title Document # SOP: Labeling and Packaging QMS-SOP-0018 3 Acronyms and Definitions Table 1: Acronyms Acronym Meaning RA Regulatory Affairs QMS Quality Management System QA Quality Assurance FDA Federal Drug Administration CFR Code of Federal Regulations Document# QMS-SOP-0027 Table 2: Definitions Acronym Description Canadian Medical The rules and regulations defined by Health Devices Regulations Canada that medical devices authorized for sale (CMDR) within Canada and their manufacturers must comply with. Medical Device A program that allows the conduct of a single Single Audit regulatory audit of a medical device Program (MDSAP) manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions (Australia, Brazil, Canada, Japan and the United States) Active Device A medical device that depends for its operation on a source of energy other than the energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. Active Diagnostic An active device that, whether used alone or in Device combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. Active Therapeutic An active device that, whether used alone or in Device combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness of injury. Body Orifice A natural opening or a permanent artificial opening in the body, such as a stoma. Closed-loop System In respect of a medical device, means a system that enables the device to sense, interpret and Document# QMS-SOP-0027  treat a medical condition without human intervention. Invasive Device A medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a Body Orifice or through the body surface. Medical Device For the purpose of these regulations a “medical device” is defined as it appears in the Food and Drugs Act with the exclusion of veterinary products. ……an article, instrument, apparatus or contrivance, including a component, part or accessory of one, that is manufactured, sold or represented for use in: 1. The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; 2. The restoration, correction or modification of a body function or the body structure of a human being; 3. The diagnosis of pregnancy in a human being; or 4. The care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug License Renewal Refers to the obligation to annually inform the (for MDL) Minister of Health as described in Section 43(1)(a) and (b) of the CMDR Annual Review (for Refers to the obligation to annually submit an MDEL) application for review to the Minister of Health as described in Section 46.1(1) of the CMDR Regulatory A person authorized by the manufacturer to act on Correspondent their behalf. Document# QMS-SOP-0027  Medical Device Refers to medical device licenses issued by the License Medical Devices Bureau on behalf of the Minister for Class II, III and IV medical devices sold in Canada. 4 Process Roles Role Description of Role QA/RA Seeking and maintaining/renewing Device Licenses for new Compass Health-made Class II devices according to the instructions provided in this procedure. Seeking and maintaining/renewing Establishment Licenses as required Appropriately classifying devices based on the applicable guidance documentation provided by relevant regulatory jurisdictions. Confirming the classification choice directly with regulatory agency and/or the designated third party registrar Submitting to regulatory partners (Intertek) and regulatory agencies (Health Canada) a copy of the QMS certificate issued for a new or modified quality management system certificate with respect to a licensed, Compass Health-made medical device within 30 days of issuance. Ensuring that the Compass Health Quality Management system is FDA and CMDR compliant and all relevant parties are adequately trained in its particular requirements. Document# QMS-SOP-0027 5 Device Licensing Process 5.1 Device Classifications by Regulatory Jurisdiction Class I devices represent the lowest potential risk and do not require a device license in Canada or the USA. Device classification decisions are made in accordance with published regulatory standards including CMDR (SOR/98-282) included for devices sold in Canada and Title 21 of the Code of Federal Regulations (CFR), Parts 862-892, for devices marketed within the USA. In Australia, device classification is performed following the guidance: Classification of medical devices that are not IVDs, July 2024 When in doubt, the proposed classification choice is confirmed directly with the appropriate national regulatory body or authorized representative/sponsor, as applicable. 5.2 Canada In Canada, manufacturers must receive a medical device Licence for certain health products defined as a "device" under the Food and Drugs Act before they can be sold in the Canadian market. To determine which devices need a License, all medical devices have been categorized based on the risks associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device License. Although Class I devices do not require a Licence, manufacturers, distributors and importers are required to obtain a Medical Device Establishment License (MDEL). 5.2.1 Medical Device Establishment License (MDEL) When Compass Health seeks to market its first Class I medical device within the Canadian market, QA/RA (or designee) shall submit an application for a Medical Device Establishment License. Within this form QA/RA shall identify the list of products/devices and associated class designation. Document# QMS-SOP-0027  5.2.1.1 Annual Review Compass Health shall submit an application for the review for their MDEL annual and pay the fee for Annual Review before April 1st of each year even if there are no changes. If Compass Health intends to add another activity or class of device, these changes must only be identified at the next application, such as annual review. No application is required prior to beginning new activities or addition different classes of medical devices. Compass Health shall notify Health Canada in writing that they intend to forgo requesting the annual establishment License review by April 1st of each year when the company ceases to manufacture Class I devices. 5.2.2 Medical Device License When Compass Health seeks to market a new class II (or higher) device within the Canadian market, QA/RA shall submit an application for a medical device license to Health Canada using the requisite format established by the Minister. The application shall contain the following information: The name of the device; The class of the device (as classified by each regulatory bodies); The identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family; The name and address of the manufacturer as it appears on the device label; and The name and address of the establishment where the device is being manufactured, if different from the one that appears on the device label. When the application is for a medical device license concerning a Class II device specifically, the following information shall also be provided by QA/RA to Health Canada: A description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented: Document# QMS-SOP-0027  A list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements established by sections 10-20 of the Canadian Medical Devices Regulations (CMDR); An attestation by Compass Health senior official that the organization has objective evidence at hand to establish that the device meets the safety and effectiveness requirements (Sections 10-20 of the CMDR); A copy of the device label In addition to providing Health Canada with the completed application form, QA/RA shall ensure that: The designated company senior official has signed the application form, certifying that all the information in the application is accurate and complete. The applicable license fee for a Class II, (or III or IV) medical device is submitted with the application. The quality management system certificate is submitted with the application. The “License Application Disclosure Request” is submitted with the application. QA/RA shall submit the application and any supporting documentation to: Device Licensing Services Division (DLSD) Medical Devices Bureau (MDB) Therapeutic Products Directorate (TPD) 11 Holland Avenue Address Locator: 3002A OTTAWA, Ontario K1A 0K9 Canada Phone: 613-957-7285 Fax: 614-957-6345 E-mail: [email protected] 5.2.3 Guidance For additional guidance on the medical device application process, see “Guidance Document: How to Complete the Application for a New Medical Device License” on the Health Canada Website. Document# QMS-SOP-0027 5.2.4 Renewal Compass Health will renew each medical device license annually and pay the renewal fee before the 1st of November, using the prescribed form. 5.2.5 Discontinuation If Compass Health discontinues the sale of a medical device in Canada, QA/RA informs the Minister within 30 days after the discontinuance. Note: Requirements unique to Class III and IV devices have been excluded from this procedure as Compass Health currently does not manufacture devices with higher classification than Class II. Should Compass Health choose, at any time, to add devices of a higher classification to its product line, this procedure shall be accordingly updated. 5.3 United States Compass Health recognizes that the FDA is the agency that regulates medical devices in the USA and Compass Health shall submit appropriate applications (e.g. 510k for Class II) and support materials to register each product/medical device. Registrar Corp. shall represent Compass Health as their US agent and Initial Importer as per the FDA QSR regulations. Registrar Corp operates from: Medical Device Department Registrar Corp 144 Research Drive Hampton, Virginia, USA 23666 Tel: +1-757-224-0177 Fax: +1-757-224-0179 Email:[email protected] Compass Health, as a FDA registered establishment, shall annually renew registration and update product listings as required via FURLS website. Document# QMS-SOP-0027  5.4 Australia In Australia, manufacturers with Canadian MDL may apply (through their sponsor) for abridgement of TGA conformity assessment in view of inclusion on the ARTG database. However, certain conditions must be fulfilled: - Same risk profile and device risk classification - Evidence of clearance in Canada, i.e. Medical Device Licence - MDSAP certificate including Australian requirements 5.5 QMS Certificate Submission Requirements 5.5.1 Health Canada If a new or modified quality management system certificate is issued with respect to a licensed, Compass Health -made medical device, QA/RA submits a copy of the certification to Health Canada within 30 days of its issuance. 5.5.2 Australia Substantial changes must be notified and assessed by the TGA prior to supplying any products (kinds of devices) affected by those changes. 5.6 Investigational Devices If Compass Health intends to sell a device for investigational testing, the following shall be done: Canada: For class I devices, Compass Health shall maintain all the records and information detailed in Section 81 of the Medical Devices Regulation. For class II devices, Compass Health shall apply for an investigation testing authorization (ITA) Document# QMS-SOP-0027  United States: Clinical investigations on human subjects involving Compass Health Investigational Devices in the U.S. are performed in conformance with 21 CFR §812, Investigational Device Exemptions, in addition to any local requirements. For Non-Significant Risk Investigations (typical for Class I and Class II devices), a clinical investigation protocol is developed, and an agreement with the IRB of the institution is required. Informed consent from the human subjects is required. Australia: All clinical trials in Australia must follow GCP principles and undergo one below schemes: -Scheme 1 CTN- Clinical Trial Notification -Scheme 1- CTA- Clinical Trial Approval Compass Health should work with their Australian Sponsor to identify the right path prior to starting the trial. 5.7 CMDR-Specific Requirements 5.7.1 Evidence of Compliance To sell-and continue to sell-a medical device in Canada, Compass Health shall maintain and make readily available to designated Third Party Registrars objective evidence of having fulfilled all requirements unique to CMDR that apply to any given Compass Health-made device. The following elements within the Compass Health Quality System have been accordingly augmented or created anew to meet this objective: Safety and Effectiveness Requirements (see Quality Manual, SOP: Risk Management, SOP: Medical Device Reporting & Mandatory Problem Reporting; SOP: Complaint Handling; CMDR Safety and Effectiveness Checklist); Labeling Requirements, e.g. requirements specific to language (see SOP: Labeling and Packaging); Document# QMS-SOP-0027  Distribution Records Requirements (e.g. record retention period) (see SOP: Control of Records, and SOP: Document Controls); Medical Device Licensing – and application for Licensing – requirements (Class II) (see section 5.2, 5.3 & 5.4 of this procedure and Quality Manual): Application for a Medical Device License Amendment requirements (see section 6.2 of this procedure); The obligation to inform and submit (see sections 6.4 and 6.5 of this procedure); Recall and Advisory Notices Requirements (see SOP: Device Recall and Advisory Notices and Advisory Notices Health Canada Documents). Note: For all other Canadian Medical Device Requirements that overlap with those prescribed by ISO 13485:2016, see Appendix B within the Compass Health Quality Manual (QMS-MAN-0010). 5.8 TG(MD)R Specific Requirements 5.8.1 Evidence of Compliance Essential Principles that apply to the medical device (see TG(MD)R Essential Principles checklist) 6 Change Notifications to Regulatory Agencies As part of the Product Development and Change Control Processes, all new or revised design and manufacturing changes are assessed for the impact on the licenses. 6.1 USA Through the use of the broad principles and detailed enumeration defined in the CDRH guidance documents “Deciding When to Submit a 510(k) for a Software Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff” and “Deciding When to Submit a 510(k) for a Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff”. A determination shall be made as to whether there is a need for a filing of a new 510(k) based on each proposed change in design. Document# QMS-SOP-0027 Note: Although there are several changes in the areas of labeling, technology and performance specifications that are typically supported within the original scope of intended use for a Class II, the sum of the incremental changes must not exceed the §807.81(a)(3) threshold, "could significantly affect the safety or effectiveness of the device". If the sum of changes exceeds the threshold, then a new 510k must be written. Regulatory shall work jointly with the Engineering team to determine the necessary regulatory requirements as required. 6.2 Canada Changes are reviewed to determine if they are considered major or significant changes to the QMS or product technology in accordance with Health Canada’s “Guidance Document for the Interpretation of Significant Change,” then Compass Health’s Registrar and Health Canada is notified. If the document change is due to one of the following situations, then a medical device license amendment is submitted to Health Canada: (a) in the case of a Class III or IV medical device, a significant change (see latest Health Canada Guidance on significant changes and flowcharts to assess whether a change is significant or not); (b) a change that would affect the class of the device; (c) a change in the name of the manufacturer; (d) a change in the name of the device; (e) a change in the identifier of the device; (f) In the case of a Class II medical device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented. If the document change affects the QMS or product and is deemed not to be significant and does not meet the situations listed above, Compass Health will notify Health Canada at the annual license renewal or Compass Health may submit to Health Canada a license amendment fax-back form or license amendment application. Compass Health will notify Health Canada within 30 days when a new or modified ISO 13485 certificate is issued to them, through the use of a faxback form and Form F202. Document# QMS-SOP-0027 6.3 Australia Changes to marketed devices or the quality management system which require notification to the TGA under the Australian conformity assessment procedures are to be notified to the MDSAP Auditing Organisation. The Australian Sponsor holds the marketing authorisation, not the manufacturer. The Manufacturer is required to notify their auditing organisation body of: - A proposed change to their QMS, including the name and location of the manufacturer - A proposed change to critical suppliers or the goods and services they provide - A proposed change to a validated manufacturing process A proposed change to the kinds of medical devices to which the system is to be applied Changes are to be evaluated by the Auditing Organisation (AO) to determine whether a special audit is required to verify the continuing integrity of the quality management system, or whether verification of the change may occur at the next routine audit. For changes that are not considered substantial by the Manufacturer or applicant, a summary of changes may be requested by the AO at the time of recertification or made available for review during the next on-site audit. Examples of substantial changes that may require notification to the TGA include, but are not limited to, the following: -Name and/or address of the Manufacturer -Scope of existing manufacturing facilities, including manufacturing steps -Addition or removal of a manufacturing facility along with associated activities -Critical manufacturing process (e.g., a drug coating process, a sterilization method etc.) -Critical supplier and/or relevant scope Type of conformity assessment procedure -Device category Product design (e.g., materials for medical devices, storage, shelf- life, and packaging) -Information to be provided with a medical device (e.g., intended purpose of the device in the IFU, removal of warnings, contraindications, or other information regarding safety etc.) Document# QMS-SOP-0027  Refer to: Therapeutic Goods (Medical Devices) Regulations 2002 - Regulation 3.5 – Medical devices manufactured outside Australia For all changes to critical processes Compass Health must notify the Auditing Organisation of their plans before implementing a change to a critical process. 7 Process Monitoring QA/RA shall remain intimately connected with the device licensing process. QA/RA shall also remain updated on the most recent version of each jurisdiction’s regulations as well as all other external documents referenced within this SOP. Status of licensing for all devices shall be made available to Management at the Management Quality Review. 8 Quality Records Record type Description Health Canada Obtained license for Compass' Class II Medical Medical Device devices in compliance with regulatory License and requirements under the Canadian Medical Renewed Device Regulations Licenses Health Canada License obtained to fabricate, package, label, Establishment distribute, import, wholesale, or test Compass' License Medical Device MDSAP Certificate to prove that Compass Health has Certification met ISO 13485:2016 standards, CMDR and FDA QSR for the Quality Management System CMDR Safety and This checklist is used to confirm the safety and Effectiveness effectiveness of the medical device as per the Checklist CMDR requirements. It shall be updated as part of the DHF. TGA Essential Principles This checklist is used to confirm the safety and checklist effectiveness of the medical device as per the Document# QMS-SOP-0027 TG(MD)R requirements. It shall be updated as part of the DHF. Document# QMS-SOP-0027