International Classification | Examples | Risk Level |
A | Chemistry analyzer | Low |
B | Urine test strips | Low - Moderate |
C | Blood Glucose self-testing | High - Moderate |
D | HIV blood analyzer | High |
International Classification | Examples | Risk Level |
A | Chemistry analyzer | Low |
B | Urine test strips | Low - Moderate |
C | Blood Glucose self-testing | High - Moderate |
D | HIV blood analyzer | High |
A | B | C | D |
Appoint a local authorized representative (AR) in Oman to submit application (required). | |||
Fill out application form and submit all required documents (listed below). | |||
If approved, applicant will receive a registration certificate |
Validity | Five years |
Postmarket Surveillance | Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities required. |
Timeline | Two years |