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About us
Who we are
Board
Executive Management
Expressions of Interest
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Quality Management System
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Special Projects
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Vacancies
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Communication to Industry
Forms
Guidelines
Complementary Meds
Application portal
Communication to Industry
Forms
Guidelines
Templates
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Communication To Industry
FAQs
Forms
Guidelines
Inspectorate and Regulatory Compliance
Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Names and Scheduling
Amended Schedules
Consolidated Schedules
Guidelines
Orthodox Medicines
Communication to Industry
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Vigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
Category A Medicines
Complementary Medicines
Medical Devices
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Veterinary Medicines
Guidelines
Registered Vet Products
Veterinary Portal
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AEFI Reporting Dashboard
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Health Product Application Status Checker
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OTC Medicines Directory
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Registered Health Products
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MEDICAL DEVICES AND IN VITRO DIAGNOSTICS POSITION STATEMENTS
Document Number
Title
Categories
Date Updated
Version
Units
File Type
Link
doc_categories_hfilter
doc_tags_hfilter
9.96
Transitional Arrangements for Medical Devices
Communication to industry
,
Position statement
27/04/2017
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.79
Medical Device Establishments: License Requirements
Communication to industry
,
Position statement
21/09/2016
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.78
Disinfectants Status of Antiseptics and Germicides
Communication to industry
,
Position statement
21/07/2016
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.106
Class A Medical Devices
Communication to industry
,
Position statement
14/09/2017
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.105
Section 21 Authorisation of Sale Unregistered Medical Devices
Communication to industry
,
Position statement
16/11/2017
1
Emergency use
,
Medical Devices
,
Section 21
,
Unregistered products
pdf
Download
communication-to-industry position-statement
emergency-use medical-devices section-21 unregistered-products
9.103
Tissue Engineering Products
Communication to industry
,
Position statement
16/11/2017
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
2.32
Wound Dressings
Communication to industry
,
Position statement
23/11/2011
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
Reprocessing of Single Use Medical Devices Communication to Stakeholders
Communication to industry
,
Position statement
20/11/2019
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
Communication to Industry Licence Amendment
Communication to industry
,
Position statement
27/11/2019
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
Communication to Industry Licence Acknowledgement Letter
Communication to industry
,
Position statement
28/11/2019
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
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