Skip to main content

Contact us
Glossary and Acronyms
FAQ
Complaints
Feedback

Main Menu Level 1

Home

Product Streams

Immunization Devices

In Vitro Diagnostics

Medical Devices

Medicines

Vaccines

Vector Control Products

Inspection Services

Events

News

eCTD

ePQS

About

Search

Immunization Devices Stream Menu

About Immunization Devices Prequalification
What We Do
Documents A-Z
WHO Catalogue of Prequalified Immunization Devices
WHO Product Standards for Immunization Devices
Procuring Prequalified Products
Prequalification Procedures & Fees
Product Testing Support for Manufacturers
Post-prequalification Commitments and Fees
Post-market Monitoring
Laboratory Accreditation for Product Testing
Product testing support for laboratories
Guidance Documents
Market Information

In Vitro Diagnostics Stream Menu

About In Vitro Diagnostic & Medical Devices Prequalification
What We Do
Documents A-Z
Prequalified In Vitro Diagnostics
In Vitro Diagnostics Under Assessment
IVDs Eligible for WHO Prequalification
Prequalification Procedures & Fees: IVDs
Post-prequalification Procedures & Fees: Prequalified IVDs
Prequalification Reports
Collaborative Procedure for Accelerated Registration
Guidance Documents
Support to Manufacturers
Emergency Use Listing Procedure
Expert Review Panel for Diagnostics
Performance evaluation
Market Information

Medical Devices Stream Menu

About Medical Device Prequalification
Documents A-Z
Prequalified Medical Devices
UNFPA listed Contraceptives acknowledged by WHO
Prequalification Reports: Medical Devices
Medical Devices Under Assessment
Medical devices eligible for Prequalification
Prequalification Procedure and Fees: Medical Devices
Timelines for Medical Devices
Post-Prequalification Procedures and Fees for Medical Devices
Guidance Documents for Medical Devices

Medicines Stream Menu

About Medicines Prequalification
What We Do
Documents A-Z
Prequalification Pipeline
Prequalified Lists
FPPs and APIs Eligible for Prequalification ("EOIs")
Prequalification Procedures & Fees: FPPs, APIs & QCLs
Post-prequalification Procedures & Fees: APIs, FPPs, QCLs
Prequalification Reports
Collaborative Procedures for Accelerated Registration
Guidance Documents
Prequalification of Biotherapeutic Products
Support to Manufacturers, CROs and QCLs
Risk Assessment
Market Information
eCTD

Vaccines Stream Menu

About Vaccines Prequalification
What We Do
Documents A-Z
List of Prequalified Vaccines
Vaccines Eligible for WHO Prequalification
Prequalification Procedures & Fees
Post-prequalification Procedures
Guidance Documents
Prequalification Reports
Emergency Use Listing Procedure
Market Information
Risk Assessment - Snake Antivenom
eCTD

VCP Stream Menu

About Vector Control Products Prequalification
What We Do
Documents A-Z
List of Prequalified Vector Control Products
Prequalification Pipeline
Prequalification Procedures & Fees
Post-prequalification Procedures & Fees
Prequalification reports
List of Vector Control Active Ingredients
WHO Specifications for Pesticides
Guidance Documents
Expert Advisory Groups

Inspection Services Stream Menu

About Inspection Services
What We Do
Documents A-Z
Inspection Services Procedures
WHO Public Inspection Reports (WHOPIRs)
Notice of Concern

SD Biosensor Inc

WHOPIR

IVD

WHOPIR_SDBiosensor-08-10April2019.pdf

Inspection Dates

8 April, 2019 - 10 April, 2019

Chungcheongbuk-do,

Republic of Korea

About us

History & Mission
What We Do
Funding
Key performance indicators

Site map

Events
News
Faq

WHO Links

World Health Organization (WHO)
WHO Essential Medicines and Health Products
WHO Global Malaria Programme
WHO Medical Devices
WHO Medicines Quality Assurance
WHO Regulation and Prequalification

logo

Privacy Legal Notice

© 2023 WHO