What's new: Medical devices
Files added to the web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks.
Consult the Drug and Health Product Register regularly for Regulatory Decision Summaries for medical devices.
Consult the Drug and Health Product Register regularly for Post-Licensing Activity Tables, which are added to Summary Basis of Decision documents for medical devices.
COVID-19
August 2023
February 2023
- 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]
October 2022
- Updated Consultation on amendments to regulations to import and sell COVID-19 medical devices [2022-10-25]
- Updated policy position COVID-19 rapid antigen self-testing devices used for serial testing: Notice to industry [2022-10-14]
September 2022
March 2022
- Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations [2022-03-02]
- Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulations [2022-03-02]
February 2022
- Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages [2022-02-22]
- Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19: Notice [2022-02-21]
- 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]
January 2022
- Subscribe to MedEffect e-Notice [2022-01-18]
- New CSA Group standard for filtering respirators: Notice [2022-01-10]
- Health Canada Launches Electronic Manufacturer's Certificate to Export [2022-01-04]
December 2021
- Information for patients: A guide to self-testing for COVID-19 [2021-12-17]
- 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]
August 2021
- Failure to pay 2021 annual licence review fees will result in cancellation of MDELs [2021-12-03]
- Industry Advisory Roundtable on COVID-19 testing: Taking stock and looking forward [2021-08-13]
- Priority strategies to optimize self-testing in Canada: Expert Advisory Panel report [2021-08-12]
July 2021
- Medical devices no longer considered to have urgent public health need status: Notice to industry [2021-07-16]
- COVID-19 rapid antigen testing devices that use serial testing for asymptomatic individuals: Notice to industry [2021-07-09]
June 2021
- Guidance for transparent medical mask technical specifications [2021-06-30]
- Cancellation of MDELs for failure to pay fees [2021-06-24]
- Industry Advisory Roundtable on COVID-19 testing: Border measures [2021-06-18]
- Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach [2021-06-15]
- Interim order regulating certain UV radiation-emitting and ozone-generating devices under Pest Control Products Act: Notice [2021-06-07]
May 2021
- Priority strategies to optimize testing and quarantine at Canada's borders: Testing Expert Advisory Panel report [2021-05-27]
- Priority COVID-19 test applications: Notice to manufacturers, importers and distributors [2021-05-07]
- Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03]
- Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents [2021-05-03]
April 2021
- 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]
March 2021
- Industry Advisory Roundtable on COVID-19 testing: Task Shifting and Self-Administration for Workplace Screening Programs [2021-03-26]
- Health Canada responds quickly to potential medical device shortages during COVID-19 [2021-03-26]
- What was heard: Consultation on interim order transition for tools to address drug and medical device shortages [2021-03-17]
- Priority strategies to optimize testing and screening for primary and secondary schools [2021-03-12]
- Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
- Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users [2021-03-01]
February 2021
- Priority strategies to optimize testing and screening in long-term care homes [2021-02-26]
- Notice to manufacturers, importers and distributors: Research use only for COVID-19 tests [2021-02-19]
- Industry Advisory Roundtable on COVID-19 report: Accelerating Rapid Screening in the Workplace [2021-02-18]
- COVID-19 Medical Device Establishment Licence (MDEL) suspensions [2021-02-11]
January 2021
- Non-contact infrared thermometers (NCIT) [2021-01-28]
- Ensuring predictability for exceptionally imported health products: Notice to industry [2021-01-22]
- Priority strategies to optimize testing and screening for COVID-19 in Canada: Report [2021-01-15]
- COVID-19 Testing and Screening Expert Advisory Panel: Reports and summaries [2021-01-15]
December 2020
- Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders [2020-12-10]
- Medical devices compliance program bulletin [2020-12-03]
- Importation and sale of medical devices for COVID-19 guidance document [2020-12-01]
- COVID-19 antibody (serology) testing: Information for patients [2020-12-01]
November 2020
- Notice to Stakeholders: New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19) [2020-11-27]
- Industry Advisory Roundtable on COVID-19 Testing, Screening, Tracing and Data Management [2020-11-26]
- Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders [2020-11-23]
- Expert outreach and collaboration on COVID-19 testing and screening [2020-11-17]
- Testing and Screening Expert Advisory Panel [2020-11-17]
- Technical requirements for UV decontamination devices: Notice to manufacturers [2020-11-06]
October 2020
- Regulatory considerations on the classification of respirators [2020-10-20]
- Health Canada's special access programs [2020-10-14]
- Notice to stakeholders: Final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs [2020-10-14]
- Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance [2020-10-07]
- Pan-Canadian COVID-19 Testing and Screening Guidance [2020-10-07]
September 2020
- Testing devices for COVID-19: Antigen testing devices [2020-09-29]
- COVID-19 guidance for reporting medical device shortages [2020-09-28]
August 2020
- Testing devices for COVID-19: test swabs safety and effectiveness [2020-08-26]
- Regulatory considerations for the importation or sale of face shields [2020-08-26]
- Safety and performance specifications for respirators during COVID-19: Guidance for Canadian manufacturers [2020-08-25]
July 2020
- Regulatory considerations on the classification of non-medical masks or face coverings [2020-07-24]
- Health Canada's regulatory response to COVID-19: Access to health products [2020-07-03]
June 2020
- COVID-19 serological testing devices: Notice on sensitivity and specificity values [2020-06-24]
- Testing devices for COVID-19: Home testing devices [2020-06-19]
- Medical devices for uses related to COVID-19 [2020-06-05]
May 2020
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2020-05-27]
- Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents [2020-05-27]
- Joint Statement on Clinical Trial Oversight in Canada [2020-05-27]
- Medical devices for COVID-19: Conducting a clinical trial [2020-05-27]
- Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19 [2020-05-05]
April 2020
- Engaging with international partners on COVID-19 [2020-04-30]
- International Coalition of Medicines Regulatory Authorities (ICMRA) statement on COVID-19 [2020-04-29]
- Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance [2020-04-23]
- Ventilators for patients with COVID-19 [2020-04-17]
- Reprocessing of N95 Respirators for Healthcare Professionals - Notice [2020-04-16]
- Health Product Advertising Incidents related to COVID-19 [2020-04-16]
- Notice - Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response [2020-04-08]
- Medical devices for use against coronavirus (COVID-19): List of products authorized under Interim Order [2020-04-08]
- Council of Chief Medical Officers of Health Communication: Use of Non-Medical Masks (or Facial Coverings) by the Public [2020-04-07]
- 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]
- Exceptional importation and sale of medical devices against COVID-19 [2020-04-05]
- Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak - Guidance to industry [2020-04-03]
- Personal protective equipment against COVID-19 [2020-04-02]
- Important regulatory considerations for the supply of medical gowns - Guidance to Industry [2020-04-02]
- COVID-19 health product industry [2020-04-01]
March 2020
- 3D printing and other unconventional manufacturing of personal protective equipment in response to COVID-19 [2020-03-31]
- Considerations in the use of homemade masks to protect against COVID-19 [2020-03-26]
- List of diagnostic devices for use against coronavirus (COVID-19) [2020-03-26]
- Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document [2020-03-26]
- Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order [2020-03-25]
- Optimizing the use of masks and respirators during the COVID-19 outbreak [2020-03-24]
- Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 [2020-03-18]
2024
December
- Updated: Regulatory enrolment process [2024-12-11]
- Drug and medical device databases [2024-12-11]
October
September
- Updated: Policy on Drug/Medical Device Combination Products - Decisions [2024-09-13]
- Nasal rinsing devices and the risk of infection [2024-09-11]
August
July
- Medical device safety [2024-07-31]
- Updated: Regulatory enrolment process (REP) [2024-07-31]
- Medical Devices Directorate Quarterly Performance Report for Q4 2023-24 [2024-07-26]
- Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices [2024-07-25]
- Share your views: Updates made to list of recognized standards for medical devices and draft guidance [2024-07-25]
June
- Consultation: Notice of intent to amend the regulations to address health product shortages in Canada [2024-06-25]
- Transparency for machine learning-enabled medical devices: Guiding principles [2024-06-13]
- Medical masks and respirators [2024-06-12]
May
- Cancellation of MDELs for non-compliance with annual licence review requirements [2024-05-28]
- Updated: Common Electronic Submissions Gateway [2024-05-23]
March
- Medical Devices Directorate Quarterly Performance Report for Q3 2023-24 [2024-03-19]
- Guidance Document: The Regulatory Enrolment Process (REP): Medical Devices [2024-03-15]
- Memorandum of Understanding between the Competition Bureau and Health Canada [2024-03-07]
February
- Guidance Document: The Regulatory Enrolment Process (REP): Medical Devices [2024-02-27]
- 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]
January
2023
December
- Updates to the medical device establishment licence application (FRM-0292) and instructions [2023-12-04]
- Medical Devices Directorate Quarterly Performance Report for Q1 and Q2 2023-24 [2023-12-04]
November
- What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2023-11-15]
- Implementing the regulatory enrolment process (REP) for medical devices regulatory activities: Revised notice [2023-11-15]
October
- Predetermined change control plans for machine learning-enabled medical devices: Guiding principles [2023-10-24]
- Medical Devices Directorate Annual Performance Report 2022-2023 [2023-10-18]
September
- 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]
August
- Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) [2023-08-30]
- Share your views: Draft Pre-market guidance for machine learning-enabled medical devices [2023-08-30]
June
- Patient lifts and risk of fall [2023-06-14]
- Medical Devices Directorate Performance Quarterly Report for Q4 2022-2023 [2023-06-08]
- Consultation on improving access to drugs and other health products in Canada [2023-06-05]
May
- Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations [2023-05-16]
April
- Updated: Medical Device Application Fee Form [2023-04-01]
March
- Updates to the Form F202 [2023-03-31]
- Serious adverse drug reactions and medical device incidents reported by Canadian hospitals [2023-03-23]
- 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]
- Medical Devices Directorate Performance Quarterly Report for Q3 2022-2023 [2023-03-17]
- Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices [2023-03-06]
January
2022
December
- Pulse oximeters [2022-12-30]
- Extension of interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives [2022-12-21]
- 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]
- Medical Devices Directorate Quarterly Performance Report for Q2 2022-23 [2022-12-01]
November
- List of Auditing Organizations (AO) recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) [2022-11-30]
- Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21]
- Guidance on clinical evidence requirements for medical devices [2022-11-15]
- List of Recognized Standards for Medical Devices [2022-11-15]
- November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting [2022-11-08]
October
- Medical devices contained in electronic health record (EHR) products: Notice to industry [2022-10-31]
- New e-learning course on understanding how medical devices are regulated in Canada [2022-10-28]
- Mpox (monkeypox) tests: Notice to industry [2022-10-19]
August
- Health Canada will continue to issue electronic manufacturer’s certificate to export [2022-08-23]
- Medical Devices Directorate Quarterly Performance Report for Q1 2022-23 [2022-08-17]
- Health product highlights 2021: Helping you maintain and improve your health [2022-08-03]
July
- Medical Devices Directorate Annual Performance Report 2021-2022 [2022-07-25]
- Medical Devices Directorate Quarterly Performance Report for Q4 2021-22 [2022-07-25]
- Medical Devices Directorate Quarterly Performance Report for Q3 2021-22 [2022-07-25]
- Health Canada is modernizing and transforming the Medical Devices Compliance Program [2022-07-21]
- Application For a New Class IV Medical Device Licence - Updated
(PDF fillable/saveable (721 K)) [2022-07-11]
(DOC Version - 150 K)
June
- Consultation: Proposed Changes to the Medical Devices Directorate's List of Recognized Standards for Medical Devices [2022-06-24]
April
- Subscribe to breast implant updates [2022-04-06]
- Breast Implants - Summary Safety Review [2022-04-06]
- Monthly Update to the List of New Safety and Effectiveness Reviews [2022-04-06]
March
- Classification of products for moxibustion: Notice to stakeholders [2022-03-14]
- Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
- Guide to reporting medical device shortages and discontinuations [2022-03-02]
February
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of findings and advice, October 27th, 2021 virtual meeting [2022-02-16]
- New one-stop web page for the medical device industry [2022-02-08]
January
2021
December
November
- Consultation: Medical device meetings draft guidance document: Overview and associated documents [2021-11-24]
- Consultation: Guidance on clinical evidence requirement for medical devices [2021-11-03]
October
- Good Machine Learning Practice for Medical Device Development: Guiding Principles [2021-10-27]
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda [2021-10-26]
September
- Mid-year update: Health products approved in 2021
- Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice [2021-09-01]
August
- Notice to industry: Regulatory requirements for UV light-emitting products with COVID-19 claims [2021-08-05]
July
- Drug and medical device highlights 2020: Helping you maintain and improve your health [2021-07-27]
- Classification of Products under the Food and Drugs Act (F&DA) [2021-07-22]
- Updated: Guidance Document: Classification of Products at the Drug-Medical Device Interface [2021-07-22]
June
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda for June 23, 2021 [2021-06-18]
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of Findings and Advice for February 23rd, 2021 Virtual Meeting via Zoom [2021-06-18]
May
- Medical Devices Action Plan: Progress report [2021-05-28]
- Medical devices directorate performance quarterly report for Q4 2020-21 [2021-05-28]
April
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda for October 29 and 30, 2020 [2021-04-26]
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of Findings and Advice for October 29 and 30, 2020 Virtual Meeting [2021-04-26]
February
January
- Regulatory innovation for health products [2021-01-29]
- Join a WebEx tutorial on the 2021 annual licence review (ALR) application process [2021-01-22]
- Consultation on Proposed Changes to the Medical Devices Directorate's Draft Guidance Document - List of Recognized Standards for Medical Devices [2021-01-15]
- Foreign risk notification for medical devices guidance document: Background [2021-01-14]
- Incident reporting for medical devices: Guidance document [2021-01-14]
- Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14]
2020
December
- Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada [2020-12-23]
- List of regulatory agencies and foreign jurisdictions [2020-12-23]
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
September
- Single incision mini-sling (SIMS) made from non-absorbable synthetic material (polypropylene) - Summary Safety Review [2020-09-18]
July
- Summary Basis of Decision (SBD) for TULSA-PRO system [2020-07-14]
- Mid-year update: Drugs and medical devices approved in 2020 [2020-07-08]
May
- Drug and medical device highlights 2019: Helping you maintain and improve your health [2020-05-28]
- Medical Devices Directorate Annual Performance Report 2019-2020 [2020-05-12]
- Medical Devices Directorate Performance Quarterly Report for Q4 2019-2020 [2020-05-08]
- Licence Amendment Fax-Back Form - Guidance for Changes to the Name of a Device Licence for Existing Device Licenses Only [2020-05-06]
April
- Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name And / Or Address Of Existing Device Licences Only [2020-04-30]
- Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant Additions / Deletions [2020-04-22]
- Class II Medical Device Licence Amendment Application Form [2020-04-15]
- Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device [2020-04-09]
- New Private Label Medical Device Licence Application Form [2020-04-07]
- Funding and Fees [2020-04-01]
March
January
2019
December
- Notice: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification [2019-12-18]
- Scientific Advisory Committee on Health Products for Women (SAC-HPW) Summary: Findings, Advice, 2019-05-16 and 17 [2019-12-06]
- Scientific Advisory Panel on Digital Health Technologies (SAC-DHT) Record of Proceedings 2018-11-23 [2019-12-10]
November
September
- Summary Basis of Decision (SBD) for BladderScan Prime Plus System [2019-09-20]
- Medical Devices Bureau Performance Quarterly Report for Q1 2019-2020 [2019-09-04]
June
- Medical Device Licence Application Fee Form [2019-07-26]
- Drug and medical device highlights 2018: Helping you maintain and improve your health [2019-06-27]
- Mandatory reporting requirements for hospitals [2019-06-26]
- Guidance Document: Pre-market Requirements for Medical Device Cybersecurity [2019-06-26]
May
- Medical Devices Bureau Performance Annual Report for 2018-2019 and Quarterly Report for Q4 2018-2019 [2019-05-30]
- Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences [2019-05-30]
- Scientific Advisory Committee on Oncology Therapies - Meeting announcement and Agenda for June 14, 2019 [2019-05-22]
- Final Report: Fees for Drugs and Medical Devices [2019-05-15]
- Performance Standards for the Fees in Respect of Drugs and Medical Devices Order [2019-05-15]
- Scientific/Expert Advisory Committee: Health Products for Women - Summary of Affiliations and Interests [2019-05-15]
April
- Scientific Advisory Committee on Digital Health Technologies - Agenda and updated Membership List [2019-05-08]
- Guidance Document - Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing [2019-04-30]
- Updated Medical Devices Licence Application Fee Form [2019-04-17]
March
- Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) - Nomination Call for Patient Group Representative [2019-03-29]
- Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada [2019-03-19]
- Clinical information on drugs and health products
- Stop illegal marketing of drugs and devices
February
- Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format [2019-02-28]
- Scientific Advisory Committee on Medical Devices used in the Cardiovascular System (SAC-MDUCS) - March 1st, 2019 Agenda [2019-02-27]
- Therapeutic Products Directorate's List of Recognized Standards (LORS) for Medical Devices [2019-02-26]
- Regulatory Decision Summary for Alinity i rHTLV-I/II assay [2019-02-25]
- Regulatory Decision Summary for Elecsys HIV DUO Screening [2019-02-25]
- Regulatory Decision Summary for Filasilk Sterilised Surgical Suture [2019-02-25]
- Regulatory Decision Summary for Filasilk Sterilised Surgical Needled Suture [2019-02-25]
- Regulatory Decision Summary for Gentrix Surgical Matrix [2019-02-25]
- Regulatory Decision Summary for Gore Molding and Occlusion Balloon Catheter [2019-02-25]
- Regulatory Decision Summary for The Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System [2019-02-25]
- Regulatory Decision Summary for PuraStat [2019-02-25]
- Medical Devices Bureau Performance Quarterly Report for Q3 2018-2019 [2019-02-25]
- Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System - Announcement of March 1, 2019 Meeting [2019-02-01]
January
- Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options [2019-01-31]
- Scientific Advisory Committee on Health Products for Women: Nomination Call for Members and Terms of Reference [2019-01-30]
- Consultation on Draft Guidance Document for Software as a Medical Device (SaMD) [2019-01-29]
- Regulatory Decision Summary for Ascyrus Medical Dissection Stent (AMDS) [2019-01-16]
- Regulatory Decision Summary for CoreValve Evolut PRO Transcatheter Aortic Valves [2019-01-16]
- Regulatory Decision Summary for Embotrap II Revascularization Device [2019-01-16]
- Regulatory Decision Summary for Guardian Sensor (3) [2019-01-16]
- Regulatory Decision Summary for Heli-FX EndoAnchor System [2019-01-16]
- Regulatory Decision Summary for Minimed 670G [2019-01-16]
- Regulatory Decision Summary for MitraClip Delivery System [2019-01-16]
- Summary Basis of Decision (SBD) for MiniMed 670G [2019-01-16]
- Regulatory Decision Summary for NovoMatrix Reconstructive Tissue Matrix [2019-01-16]
- Regulatory Decision Summary for Occlusin Embolization Microspheres [2019-01-16]
- Regulatory Decision Summary for Pipeline Flex Embolization Device With Shield Technology [2019-01-16]
- Regulatory Decision Summary for Straumann Cerabone [2019-01-16]
- Regulatory Decision Summary for Virotrol HIV-1 gO [2019-01-16]
- Regulatory Decision Summary for WEB Aneurysm Embolization System [2019-01-16]
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