The Medical Device Authority (MDA) of Malaysia has released the Third Edition Guidance on special access for unregistered medical devices. This update introduces a more structured and stricter process, replacing the previous notification-based system (including email submissions and Route A/B classification) with a single, mandatory online application via the MeDC@St system.
Eligibility is now limited to local manufacturers or Authorized Representatives (AR), enhancing regulatory accountability. The guidance also sets a fixed validity period of 6 months (non-extendable), strengthens labelling requirements, and outlines clear post-approval handling (e.g. disposal, export, or registration).
Overall, the update shifts towards a more controlled, digital, and compliance-focused framework.
Read the full updated guidance here: [PDF]
Purpose of the Guidance Update
- To introduce a revised framework governing the import and/or supply of unregistered medical devices under the special access exemption application process.
- To replace the previous notification-based system with a centralized online submission mechanism.
Scope of Application
This guidance applies to applications for special access exemption for unregistered medical devices in Malaysia.
Applications are limited to local manufacturers or Authorized Representatives (AR).
Key Highlights
- Mandatory online submission via MeDC@St
- Removal of Route A and Route B classifications
- Applications limited to local manufacturer or Authorized Representative (AR)
- Fixed validity period of 6 months (no extension)
- Enhanced labelling requirements
- Clear post-approval handling requirements (e.g. disposal, export, or registration)
Implications to Clients
- Applications must be submitted through local entities or Authorized Representatives (AR), with full compliance to the revised submission requirements.
- Applicants should plan ahead for product registration within the 6-month validity period, as extensions are not permitted.
- Companies should review internal procedures to align with the mandatory online submission process and enhanced compliance requirements.
Effective Date
March 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.