Open Government Portal

Found 7373 records

This document outlines the strategy and provides guidance for the medical device industry on Health Canada's compliance and enforcement activities.

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Medical Device Compliance and Enforcement guidance for the medical device industry.

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Guidance on Medical Device Establishment Licensing medical device industry regulatory requirements of Medical Device.

Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime developing and least-developed countries import high-quality drugs and medical devices a lower cost drug and medical devices.

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Safe medical devices.

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Medical Devices health or medical instruments medical devices approved and authorized.

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Good clinical practices inspection and investigation functions reduce risks to subjects enrolled in clinical trials.

We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Public release of clinical information

Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Clinical information approval of new drug and health products.

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Food and Drug Regulations Service Standard for the Right to Sell Drugs the Right to Sell Drugs authorized for sale in Canada service delivery standard of 120 calendar days.

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Drug Establishment Licences comply with drug establishment licence regulation.