DOCUMENT                                                                                                                  Date published

Regulations Amending the Medical Devices    Regulations

July 16th, 2015
November 2007
Guidance Document – Fees for the Review of Medical Device Licence Applications 2015 November,20th 2015
 

Medical Devices Regulations

 July 16th,2015
Frequently Asked Questions – Medical Devices Regulations May 1st,2015
 

Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices

 November 18th,2013
 

MEDICAL DEVICEL IICENCE APPLICATION FEE FORM

 June 3rd,2015
 

NEW CLASS IV MEDICAL DEVICE LICENCE APPLICATION FORM

 April 2015
 

NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM

 April 2015
NEWCLASS II MEDICAL DEVICE LICENCE APPLICATION FORM June 2015
Application for a Medical Device Licence Amendment for a Private Label Medical Device December 2010
 

CLASS II MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM

June 2015
 

CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM

 April 2015
 

CLASS III MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM

 April 2015
Declaration of Conformity 2006/09/11
 

INVESTIGATOR’S AGREEMENT IN ACCORDANCE WITH SUBSECTION 81(k) OF THE
MEDICAL DEVICES REGULATIONS

 February 22,1999
 

CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM

 April 2015
Health Products and Food Branch Inspectorate Medical Device Establishment Licence

 

Application

 

Form and Instructions

 December 12,2015
 

MEDICAL DEVICES LICENCE AMENDMENT FAX-BACK FORM – GUIDANCE FOR NON-SIGNIFICANT ADDITIONS/DELETIONS

June 2006
 

APPLICATION FOR INVESTIGATIONALTESTING AUTHORIZATION

 February 1999
 

CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM

 February 1999
LICENCE AMENDMENT FAX-BACK FORM February 1999

 

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