Medical Devices

A Canadian Medical Device License (MDL) is required for companies selling Class II – IV medical devices in Canada. For manufacturers, importers and distributors selling medical devices into the Canadian market place, navigating regulatory requirements can be challenging. Our professionals bring real-world experience to make your Health Canada, U.S. FDA and international classification and preparation of regulatory submissions for registration of medical device.

We provide the following medical devices regulatory registration and establishment licensing application services.

• Regulatory Audit Preparation
• Quality System Implementation & Maintenance
• ISO 13485:2016
• FDA CFR 21 Part 820 – Quality System Regulation
• MDSAP (Medical Device Single Audit Program)
• MDEL (Medical Device Establishment Licensing)
• HEALTH CANADA – Medical Device Licencing
• FDA 510(K) Submissions

ISO 13485 for Medical Devices

Audit Criteria for Medical Devices in Canada: ISO 13485 & MDSAP Compliance

The Canadian medical device industry is governed by some of the most rigorous quality and compliance expectations in the world. Health Canada mandates that Class II, III, and IV devices be manufactured under a certified ISO 13485 quality management system—and since 2019, only manufacturers enrolled in the Medical Device Single Audit Program (MDSAP) can maintain their licenses.

At MCS Associates, our third-party audits help device manufacturers, contract manufacturers, and distributors meet Health Canada, ISO, and global MDSAP standards—ensuring that your systems are robust, documented, and inspection-ready.

Regulatory Reference:

• Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act

Key Audit Criteria:

• Device classification and licensing (Class II–IV)
• Device labeling and bilingual requirements
• Safety and effectiveness substantiation
• Complaint handling and mandatory problem reporting (MPR)
• Importer and distributor oversight
• Retention of technical documentation and device history records

ISO 13485 is the globally recognized QMS standard for medical device manufacturing, covering everything from design and development to post-market surveillance.

Audit Criteria Include:

• Documented quality system procedures
• Risk-based product development and design controls
• Production and process validation (IQ/OQ/PQ)
• Traceability and UDI compliance
• Internal audits and management reviews
• Calibration, maintenance, and environmental controls
• Supplier evaluation and control
• CAPA and nonconformance management
• Personnel training and qualification

ISO 13485 is not just a standard—it’s a license to operate in Health Canada-regulated markets.

Health Canada is a full participant in MDSAP, which allows a single audit to satisfy regulatory requirements for:

• Canada (Health Canada)
• United States (FDA)
• Japan (PMDA/MHLW)
• Brazil (ANVISA)
• Australia (TGA)

MDSAP Audit Structure: The MDSAP audit model is process-based and structured into five key processes:

1. Management Controls – QMS planning, resource allocation, and performance oversight
2. Device Marketing Authorization & Facility Registration – Licensing and labeling compliance
3. Measurement, Analysis & Improvement – CAPA, audits, data analysis
4. Design & Development Controls – Risk management and usability engineering
5. Production & Service Controls – Material control, manufacturing, equipment maintenance

Each process includes linkages to ISO 13485 clauses and country-specific regulatory requirements.

• Verification of Medical Device Licence (MDL) and Establishment Licence (MDEL) status
• Audit of clinical evaluation documentation (Class III/IV devices)
• UDI (Unique Device Identification) readiness
• Cybersecurity protocols for software-enabled devices
• Validation of sterilization and packaging integrity systems
• Outsourced process control and contract manufacturer oversight
• Product complaint handling and adverse event reporting

MCS Associates combines regulatory intelligence, QMS expertise, and real-world manufacturing insight to deliver ISO 13485 and MDSAP-aligned audits that protect your license, product integrity, and brand.

• Deep familiarity with Health Canada’s MDSAP implementation policies
• Auditors trained in ISO 13485, MDR/IVDR (EU), and FDA QSR alignment
• Experience auditing Class II–IV devices across orthopedic, diagnostic, implantable, and digital health sectors
• Clear, actionable reports with risk classification and CAPA guidance
• Vendor and contract manufacturer audits across global supply chains

Whether you’re applying for your first MDL, preparing for an MDSAP re-audit, or validating a new product line, MCS Associates delivers the audit readiness and QMS resilience you need to lead in Canada’s competitive medical device market.

Contact us today to schedule a custom ISO 13485 or MDSAP audit consultation.