版權說明：本站所有國際法規及標準來源為各國衛生主管機關於網路之公開資訊，版權為各國衛生主管機關所有，本站刊載，僅限於促進醫療器材產業發展、科技進步、讀者方便搜尋查閱之目的。法規之正確性請詳加斟酌，另本站行為如侵犯了您的合法權益，請來信告知，我們將妥善處理。給您帶來不便，敬請原諒。

 

 

1.         Medical Devices Regulations(2015)

2.         Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees(2013)

3.         Fees for the Review of Medical Device Licence Applications(2013)

4.         Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices(2013)

5.         Medical device establishment licence application: form and instruction(FRM-0292)(2012)

6.         How Health Canada inspects medical device establishments (2016)

7.         Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)(2012)

8.         Policy on the Canadian medical devices conformity assessment system quality systems(2000)

9.         ISO 13485 (2003) Quality Management System Audits Performed by Health Canada Recognized Registrars

10.    Risk classification of GMP observations(2012)

11.    Opportunity to be Heard in the Suspension of a Medical Device Licence(2011)

12.    Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs)(2011)

13.    Guidance for the Interpretation of Significant Change of a Medical Device(2011)

14.    Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices(2011)

15.    Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device(2011)

16.    Guidance Document - How to Complete the Application for a New Medical Device Licence(2011)

17.    Guidance Document - Private Label Medical Devices(2011)

18.    Good Manufacturing Practices Guidelines(2009)

19.    Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations(2006)

20.    Cleaning validation guidelines(2008)