|
Type of Update and Link
|
Date Posted
|
|
Guidance Document - Preparation of Regulatory Activities in eCTD Format
|
14 April 2020
|
|
Class II Medical Device Licence Amendment Application Form
|
15 April 2020
|
|
Medical Devices Licence Amendment Fax-Back Form - Guidance for
Non-Significant Additions / Deletions
|
22 April 2020
|
|
Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot
for Clinical Trials
|
22 April 2020
|
|
Guidance Document on the Distribution of Drugs as Samples
|
29 April 2020
|
|
Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to
the Manufacturer's Name And / Or Address Of Existing Device Licences Only
|
30 April 2020
|
|
Type of
Update and Link
|
Date Posted
|
|
COVID-19
|
|
|
Notice: Expedited Review of Health Product Submissions and Applications
to address COVID-19
|
18 Mar 2020
|
|
Applications for Medical Devices under the Interim Order for Use in
Relation to COVID-19 - Guidance Document
|
26 Mar 2020
|
|
COVID-19 health product industry
|
01 April 2020
|
|
Exceptional importation and sale of medical devices against COVID-19
|
05 April 2020
|
|
Exceptional importation and sale of drugs and biocides against COVID-19
|
05 April 2020
|
|
Interim Order Respecting Drugs, Medical Devices and Foods for a Special
Dietary Purpose in Relation to COVID-19
|
05 April 2020
|
|
Guidance Document: How to Complete the Application for a New Medical
Device Licence/Medical Device Licence Amendment for a Private Label Medical
Device
|
09 April 2019
|
|
Health Product Advertising Incidents related to COVID-19
|
16 April 2020
|
|
Management of clinical trials during the COVID-19 pandemic: Notice to
clinical trial sponsors
|
22 April 2020
|
|
International Coalition of Medicines Regulatory Authorities (ICMRA)
statement on COVID-19
|
29 April 2020
|
|
Engaging with international partners on COVID-19
|
30 April 2020
|
|
Application for a Medical Device Licence Amendment for a Private Label
Medical Device
|
07 April 2020
|
Clinical Trial Operations
Regulatory and Drug Development Consulting
Government and Public Health Services
Biometrics
Clinical Pharmacology Modeling Simulation