Registration approval is not the end, it is the beginning of regulatory responsibility.
01
Certificate Validity
Registration certificates are valid for 5 years.
02
Ongoing Obligations
Adverse event reporting Product variation notifications Labeling updates Distributor changes Renewal submissions before expiry
03
Market Surveillance
MOHAP may request additional documentation or conduct inspections.
04
Recommendations
Manufacturers should establish a compliance calendar and regulatory file maintenance system.
