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About us
Who we are
Board
Executive Management
Expressions of Interest
Quality Management System
Regulatory Partnerships
Special Projects
Backlog
Vacancies
Tenders
Operational Units
Biologicals
Communication to Industry
Forms
Guidelines
Complementary Meds
Application portal
Communication to Industry
Forms
Guidelines
Templates
Clinical Trials
Communication To Industry
Forms
Guidelines
Inspectorate and Regulatory Compliance
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
News & Updates
Safety Information
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
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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
Communication to Industry Licence Acknowledgement Letter
Communication to industry
,
Position statement
2019 Nov
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
Communication to Industry Licence Amendment
Communication to industry
,
Position statement
2019 Nov
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
2019 Nov
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
2.32
Wound Dressings
Communication to industry
,
Position statement
2011 Nov
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.103
Tissue Engineering Products
Communication to industry
,
Position statement
2017 Nov
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
2017 Nov
1
Emergency use
,
Medical Devices
,
Section 21
,
Unregistered products
pdf
Download
communication-to-industry position-statement
emergency-use medical-devices section-21 unregistered-products
9.106
Class A Medical Devices
Communication to industry
,
Position statement
2017 Sep
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
2016 Jul
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.79
Medical Device Establishments: License Requirements
Communication to industry
,
Position statement
2016 Sep
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
9.96
Transitional Arrangements for Medical Devices
Communication to industry
,
Position statement
2017 Apr
1
Medical Devices
pdf
Download
communication-to-industry position-statement
medical-devices
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