Class A — Notification / Listing
Overview
Class A devices use a notification (self-declaration) pathway — the fastest and least burdensome registration route under Act 737. No independent conformity assessment body review is required, but the manufacturer remains fully responsible for the accuracy of their self-declaration.
Eligibility
The notification pathway is available for:
- Standard Class A — non-sterile, non-measuring low-risk devices
- Class A sterile — Class A devices supplied in a sterile state (with additional sterility documentation)
What You Need to Prepare
Dossier Contents for Class A Notification
| Section | Required Documents |
|---|---|
| Administrative | Application form, establishment licence details, GMDN code, intended purpose statement |
| Device Description | General description, variants/configurations, materials in contact with body |
| Classification | Classification justification referencing specific rules from Regulations 2012 |
| Labelling | Proposed label and IFU (in English; Bahasa Malaysia as required) |
| Self-Declaration | Signed declaration of conformity to Essential Principles of Safety and Performance |
| Standards | List of standards applied and whether fully or partially complied with |
For Class A Sterile Devices (Additional)
| Section | Required Documents |
|---|---|
| Sterility | Sterilisation method description and validation summary |
| Sterile Barrier | Sterile barrier system design and validation summary |
| Shelf Life | Accelerated and real-time stability data summary |
Application Process via MyMDA
- Log into MyMDA portal
- Select Device Registration → New Application → Class A Notification
- Complete the online form and upload all required documents
- Submit application and pay the registration fee (RM 500)
- MDA processes the notification within 30 working days
- Upon completion, the DRN is issued electronically
Self-Declaration of Conformity
The self-declaration must:
- Be signed by an authorised representative of the manufacturer (or the LAR where permitted)
- State that the device conforms to all applicable Essential Principles
- Reference the standards or other means used to demonstrate conformity
- Be dated and version-controlled
Legal Responsibility
The self-declaration does not mean MDA has independently verified conformity. MDA may conduct post-market audits or market surveillance checks on Class A devices. Non-conforming devices can be subject to recall, enforcement action, and prosecution.
Post-Registration
After receiving the DRN for a Class A device:
- Maintain the self-declaration and supporting documentation on file
- Notify MDA of any significant changes via a variation application
- Monitor for adverse events and report as required
- Renew registration before the 5-year expiry