Registration Renewal

Registration Validity

All medical device registrations in Malaysia are valid for 5 years from the date of approval. At the end of this period, the registration must be renewed or the device can no longer be legally supplied.

When to Apply for Renewal

MDA recommends submitting a renewal application at least 6 months before expiry. The MyMDA portal will send reminder notifications as expiry approaches.

Do not wait until the last moment — if a deficiency letter is issued during renewal review, responding and completing the process takes time. Devices with lapsed registrations cannot be supplied.

What Triggers a Full Renewal vs Streamlined Renewal?

Scenario	Type of Renewal
No significant changes to device or documentation since registration	Streamlined renewal
Minor updates to labelling, IFU, or administrative details	Streamlined renewal (with change documentation)
Changes to device design, materials, or intended use	Full renewal with updated technical dossier
New clinical data materially affecting benefit-risk	Full renewal with updated CER
New safety signals or incidents affecting risk profile	Full renewal with updated risk management file

Renewal Dossier Contents

Streamlined Renewal (No Significant Changes)

• Completed renewal application form
• Confirmation of no significant changes (or details of minor changes)
• Current establishment licence
• Updated ISO 13485 certificate (if renewed since original registration)
• Updated label/IFU (if minor changes)
• Summary of post-market surveillance data collected during the registration period
• Renewal fee payment

Full Renewal (Significant Changes or Class C/D)

All streamlined renewal contents plus:

• Updated technical documentation reflecting changes
• Updated Clinical Evaluation Report (Class C and D)
• Updated Post-Market Clinical Follow-Up data (Class C and D)
• Updated Risk Management File
• Updated PSUR if applicable

Post-Market Surveillance Summary

For all renewals, MDA expects a PMS summary covering the registration period:

• Number of devices supplied in Malaysia and globally
• Summary of adverse events reported (or confirmation of nil)
• Summary of FSCAs and complaints
• Summary of post-market clinical follow-up data (Class C and D)
• Assessment that the benefit-risk profile remains acceptable

Lapsed Registrations

If a registration lapses without renewal:

• The device cannot be supplied in Malaysia
• Stock already in the supply chain may need to be quarantined
• A new full registration application may be required (not just a renewal)
• This can result in significant market disruption

Set Calendar Reminders

Do not rely solely on MyMDA email reminders. Set internal calendar reminders at 12, 9, 6, and 3 months before each device registration expiry date.

Renewal Fee

Device Class	Renewal Fee (MYR)
Class A	RM 200
Class B	RM 500
Class C	RM 1,000
Class D	RM 2,000

Processing time for renewal: approximately 60 working days (streamlined); longer for full renewals with significant changes.