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About us
Who we are
Board
Executive Management
Expressions of Interest
Digital Transformation
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
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
Veterinary Medicines
Veterinary Medicines
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
OTC Toolkit
Pharma Licenced Establishments
Revoked or Suspended Pharma Licences
PI & PIL Repository
Registered Health Products
Registered Vet Products
E-Services
Adverse Drug Reaction Reporting
AEFI Reporting Dashboard
Complementary Medicines Licensing
COVI-VIG Reporting System
Health Product Application Status Checker
Health Products Variations Status Checker
Lot Release Search
OTC Medicines Directory
OTC Toolkit
Product Variations Portal
Med Safety App
Registered Health Products
Section 21 Applications
VET Status Checker
VET Variation Status Checker
E-Library
Corporate & Publications
Annual Reports
Documents For Comments
Fees
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Planning Documents
Position Statements
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Forms
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Medical Devices And In Vitro Diagnostics Guidelines
Document Number
Title
Categories
Date Updated
Version
Units
File Type
Link
doc_categories_hfilter
doc_tags_hfilter
SAHPGL-MD-07
Guideline on Questions and Answers Licensing of Medical Device Establishments
FAQ
,
Guideline
17/11/2023
3
Medical Devices
pdf
Download
faq guideline
medical-devices
8.01
General Information Medical Devices And IVDs
Guideline
13/08/2014
1
Medical Devices
Download
guideline
medical-devices
8.06
Guideline For Access To And Control Of Medical Devices And IVDs
Guideline
18/04/2017
1
Medical Devices
Download
guideline
medical-devices
SAHPGL-MD-06
Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs
Guideline
23/03/2023
3
Medical Devices
pdf
Download
guideline
medical-devices
SAHPGL-MD-05
Guideline on Medical Device Quality Manual
Guideline
14/03/2023
4
Medical Devices
pdf
Download
guideline
medical-devices
SAHPGL-MD-04
Guideline for Classification of Medical Devices and IVDs
Guideline
25/03/2023
3
Medical Devices
pdf
Download
guideline
medical-devices
8.04
Recalls Vigilance Medical Devices IVDs
Guideline
14/11/2019
3
Medical Devices
pdf
Download
guideline
medical-devices
8.02
Medical Device IVD Essential Principles
Guideline
14/11/2019
2
Medical Devices
Download
guideline
medical-devices
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