The Medical Devices Introductory Course 2020

The Organisation for Professionals in Regulatory Affairs

Key Device Requirements & Implications

• Medical Device Establishment License (MDEL) must be in place for (low risk) class I medical device (legal) manufacturers or their importers / distributors

• Medical Device Licenses (MDL) must be held for all medium to high risk class II, III and IV devices – this is applicable to device constituents that are co-packaged or cross-labelled with drugs (it does not apply to device constituents that are integrated parts of a singular combination product which is intended to deliver a drug)

• ISO 13485 Quality Management System Audits by MDSAP Auditing Organisations are required at legal manufacturers (and significant subcontractors) of device constituents that are co-packaged or cross-labelled with drugs. For single entity, integrated drug/device combination products intended for drug delivery, the device constituent does not need to be regulated as a device but appropriate quality, safety and efficacy requirements should still apply and, therefore, similar quality management systems (and other device) requirements could be demanded by Health Canada • Registration Process (especially for Class III-IV MDL applications and Class II-IV quality systems requirements) need to be taken into account in any co-packaged / cross-labelled product launch strategy and “appropriate” requirements for device constituents of single entity combination products should also be considered to ensure device approval strategy are mapped to drug submission plans

• Post-marketing Incident Reporting Requirements for device constituents of co-packaged (or cross- labelled) drug/device products need to managed alongside drug pharmacovigilance processes. Need to be aware of when, which, what, where and how to report device events and any (dual) reporting for drug constituent event