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
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
Examples of significant changes requiring a formal variation application include: changes to device design, materials, or intended use; relocation of manufacture; changes to sterile barrier system or sterilisation method (for Class A Sterile); material changes to IFU that affect safety or performance; and any change in the manufacturing quality system scope. Minor updates such as cosmetic label changes or correcting typographical errors may be submitted as administrative variations. When in doubt, contact MDA before making changes.