What’s new: Drugs and health products compliance and enforcement

COVID-19

• Medical devices for use in relation to COVID-19 [2023-02-22]
• Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice [2023-02-22]
• List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 [2023-02-22]
• Updates to the Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 [2022-12-16]
• Keeping Health Products In Canada Safe [2022-04-05]
• Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations [2022-03-02]
• Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulations [2022-03-02]
• Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulations [2022-03-02]
• Notice: Period reduced for keeping clinical trial records for drugs and natural health products [2022-03-02]
• Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages [2022-02-22]
• Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022 [2022-02-16]
• Updates to list of medical devices for mandatory shortage reporting: Notice [2022-02-10]
• Webinar tutorial on the 2022 annual licence review application process [2022-02-01]
• Subscribe to MedEffect e-Notice [2022-01-18]
• Health Canada Launches Electronic Manufacturer's Certificate to Export [2022-01-04]
• What MDEL holders need to know about annual licence review for 2022 [2021-12-14]
• Interim Enforcement approach for Federal, Provincial and Territorial COVID-19 Testing Initiatives [2021-12-13]
• Failure to pay 2021 annual licence review fees will result in cancellation of MDELs [2021-12-03]
• What we heard report: Records retention consultations related to the clinical trials interim order transition regulations [2021-11-19]
• Cancellation of MDELs for failure to pay fees [2021-06-24]
• Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach [2021-06-15]
• Notice: Technical requirements for anti-microbial claims for medical masks [2021-04-21]
• Canada's approach to onsite inspections during COVID-19: Notice [2021-04-07]
• Health Canada updates list of medical devices for mandatory reporting of shortages [2021-04-08]
• Updated requirements for COVID-19 drug authorizations: Notice [2021-03-31]
• Health Canada responds quickly to potential medical device shortages during COVID-19 [2021-03-18]
• What was heard: Consultation on interim order transition for tools to address drug and medical device shortages [2021-03-17]
• Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
• Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders [2020-12-10]
• Access Consortium statement on COVID-19 vaccines evidence [2020-12-03]
• Medical devices compliance program bulletin [2020-12-03]
• Notice to stakeholders: Consultation on amending the Food and Drug Regulations to expedite access to COVID-19 drugs [2020-12-01]
• Consultation: Amending the Food and Drug Regulations to provide expedited access to COVID-19 drugs [2020-12-01]
• Notice to Stakeholders: New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19) [2020-11-27]
• Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders [2020-11-23]
• Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 [2020-10-19]
• Notice Interim order on preventing and alleviating drug shortages in relation to COVID-19 [2020-10-19]
• Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance [2020-10-07]
• COVID-19 guidance for reporting medical device shortages [2020-09-28]
• Health Canada's regulatory response to COVID-19: Access to health products [2020-07-03]
• Border requirements for importing and exporting health products (COVID-19) [2020-06-10]
• Engaging with international partners on COVID-19 [2020-04-30]
• Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2020-04-05]
• Medical device shortages [2020-04-05]

2025

• Notice: Animal-sourced insulin discontinuation [2025-03-18]
• Salbutamol nebules and metered-dose inhalers in short supply: Notice [2025-02-04]
• Updates to Mutual Recognition Agreement between Canada and Switzerland [2025-01-31]

2024

• Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada [2024-12-30]
• Drug shortages in Canada: Fiscal year 2023 to 2024 in review [2024-11-20]
• Guide to validation of terminal sterilization process of drugs (GUI-0074) [2024-11-12]
• Natural health products good manufacturing practices pre-inspection package [2024-10-07]
• How to develop a corrective and preventive action plan (CAPA) [2024-09-27]
• Cancellation of MDELs for non-compliance with annual licence review requirements [2024-05-28]
• Proposed amendments to the Food and Drugs Act: Precision Regulating [2024-05-03]
• Drug Quality Surveillance Program [2024-02-22]
• Consultation open for foreign building compliance with drug good manufacturing practices (GUI-0080) [2024-02-14]
• Canada's regulations prevent drugs from being distributed outside the country if this could cause or worsen a shortage [2024-02-08]
• Draft guidance on how to interpret 'significant change' of a medical device [2024-02-07]
• Share your views: Draft guidance on how to interpret 'significant change' of a medical device [2024-02-07]
• Amendments to the Medical Devices Regulations to address future public health emergencies [2024-01-03]

2023

• Updates to the medical device establishment licence application (FRM-0292) and instructions [2023-12-04]
• What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2023-11-15]
• Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs (GUI-0066) [2023-09-29]
• Share your views: Consultation on draft guidance for determining medical device application type [2023-09-11]
• Updates to the guidance on medical device establishment licensing (GUI-0016) [2023-09-06]
• Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) [2023-08-30]
• Patient lifts and risk of fall [2023-06-14]
• Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies [2023-03-23]
• Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice [2023-03-23]
• Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices [2023-03-06]
• Tubed medical devices and children [2023-01-27]
• Drug shortages in Canada: Information for consumers [2023-01-20]

2022

• Potential risk of falls from infant incubators and radiant warmers [2023-07-13]
• Consultation on proposed agile regulations and guidance for licensing drugs and medical devices [2022-12-16]
• What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 [2022-12-02]
• Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21]
• Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence [2022-11-21]
• Changes made to list of non-prescription drugs: Notice of modification [2022-10-28]
• Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders [2022-10-03]
• Subscribe to medical device updates [2022-09-16]
• Health Canada will continue to issue electronic manufacturer's certificate to export [2022-08-23]
• Subscribe to breast implant updates [2022-04-06]
• Registration and notification guide for donor sperm and ova establishments (GUI-0128)
• Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
• Exceptional importation and sale of biocides in relation to COVID-19: For industry (Guidance) [2022-03-02]
• Drug shortages in Canada: Regulations and guidance [2022-03-02]
• Guide to reporting medical device shortages and discontinuations [2022-03-02]
• What we heard report on the clinical trials regulatory modernization initiative [2022-02-23]
• Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148) [2022-02-21]
• New one-stop web page for the medical device industry [2022-02-08]

2021

• Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145) [2021-11-10]
• Guide on the requirements for providing information related to drug shortages (GUI-0146) [2021-11-10]
• Prescription status of edaravone and personal importation: Notice of update [2021-09-29]
• Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice [2021-09-01]
• The Drug Establishment Licensing Bulletin [2021-08-10]
• Policy on Individual(s) accompanying a health products inspector (POL-0141)
• Policy on inspector orders for health products [2021-03-17]
• Policy on collection and retention of records related to health product compliance and enforcement [2021-03-17]
• Policy on accessing the premises of a regulated party remotely to verify compliance [2021-03-01]
• Regulatory innovation for health products [2021-01-29]

2020

• Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
• Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply): Notice [2020-11-28]
• Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [2020-11-28]
• Regulatory requirements for importing medical devices [2020-10-20]
• Annex 3B to the Good manufacturing practices guide - Positron-emitting radiopharmaceuticals (GUI-0071) [2020-09-15]
• Risk classification guide for drug good manufacturing practices observations (GUI-0023) [2020-08-31]
• Nitrosamine impurities in medications [2020-08-24]
• Guidelines for environmental control of drugs during storage and transportation [2020-08-24]
• Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005) [2020-07-17]
• Good manufacturing practices guide for drug products (GUI-0001) [2020-07-01]

2019

• Mandatory reporting requirements for hospitals [2019-06-26]

2018

• Consultation on the Revised Inspection Strategy for Licensed Blood Establishments [2018-07-31]
• Good manufacturing practices guide for drug products (GUI-0001) effective on [2018-10-01]
• Risk classification guide for drug good manufacturing practices observations (GUI-0023) [2018-02-28]
• Good manufacturing practices for medical gases (GUI-0031) effective on [2018-10-01]
• Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs (GUI-0119) effective on [2018-10-01]
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) [2018-01-19]

Recall Reporting for Medical Devices:

• Medical devices recall guide (GUI-0054)
• Medical device initial recall reporting form (FRM-0360)
• Medical device final recall reporting form (FRM-0360)

2017

• Notice - Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) [2017-02-10]

2016

• Health product complaint form (FRM-0317) [2016-12-19]
• How Health Canada inspects medical device establishments (GUI-0064) [2016-11-17]

2015

• Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients [2015-07-31]
• Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12]
• Toronto 2015 Pan American and Parapan American Games - Importing and Exporting Controlled Substances, Precursor Chemicals and Therapeutic Products [2015-04-27]
• Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) [2015-04-01]
• Important Information to Stakeholders Implementation of Advance Notice of Importation Process Pilot for Cosmetics and Drugs [2015-03-13]
• Blood Regulations - Error or Accident Investigation Preliminary Report Form (FRM-0337) [2015-03-02]
• Blood Establishment Registration Application: Form and Instructions - (FRM-0353) [2015-01-29]
• Blood Establishment Licensing Application Form and Instructions - (FRM-0354) [2015-01-29]