Module 19 2021

01/06/2021

Considerations in the RCP Risk

Product risk is one of the key elements to registration requirements

CLASS

LEVEL

DEVICE EXAMPLES

A

Low Hazard

Instruments

B Low-moderate Hazard C Moderate-high Hazard D High Hazard

Many lab tests e.g. hCG

STDs tests etc

HIV/HCV tests

HIGHER

REGULATORY REQUIREMENTS

LOWER

A

B

C

D

DEVICE CLASS

29

Considerations for the RCP enablers

• QS certification – Notified body? • External Testing – Are the test transferrable? E.g EMC in China? • Local Agent – Are they reliable? Will they charge? • Certificates – CFG* or CFS: are they available and acceptable from your country e.g. Argentina – Chemical Hazard e.g. SDS – CE or others

QS Certificate

External Testing

Local Agent

Certificate

* certificate to foreign govt

ENABLERS

30

15