Registration approval is not the end, it is the beginning of regulatory responsibility.

Certificate Validity

Registration certificates are valid for 5 years.

Ongoing Obligations

• Adverse event reporting
• Product variation notifications
• Labeling updates
• Distributor changes
• Renewal submissions before expiry

Market Surveillance

MOHAP may request additional documentation or conduct inspections.

Recommendations

Manufacturers should establish a compliance calendar and regulatory file maintenance system.