Medical Devices

Public Warning / Advisories

• Advisories for Health Professionals or Consumers

Problem Reporting

• Adverse Reaction Information
• Medical Device Problem Reporting by Healthcare Facilities, Medical Professionals and other device users
• Medical Devices Problem Report Form

Establishment Licences

• Companies that hold a Medical Device Establishment Licence
• Guidance on Medical Device Establishment Licensing
• Medical Devices Establishment Licence Application Form
• Medical Device Establishment Licence: Fee Reduction Request

Medical Device Product Licences Issued

Inspection Programme

• Guidance on the Medical Device Inspection Programme
• Inspection Strategy for Medical Device Companies

Regulatory Amendments

• Letter to Stakeholders Regarding Proposed Amendments to the Medical Devices Regulations - Schedule 1426

Guidance

• Guidance for Medical Device Complaint Handling and Recalls
• Mandatory and Voluntary Problem Reporting for Medical Devices

Recalls

• Drug and Medical Device Recall Listings
• Health Products and Food Branch Inspectorate - Recall Policy
  (POL-0016)
• Product Recall Procedures

Guidance Documents, Directives & Policies

• Quality System Framework 2005
• Compliance and Enforcement Policy (POL-0001), Version 2
• Medical Device Compliance and Enforcement Directive (POL-0045)
• Schedule A and Section 3: Guidance Document

Visit the Medical Devices section for more documents and information on medical devices