The Medical Device Authority (MDA), Malaysia has issued an Interim Directive on Implantable Device Traceability concerning the traceability requirements for implantable medical devices under Subregulation 3(2) of the Medical Device Regulations 2019.
While the legal obligation for establishments to maintain traceability records down to the patient level remains in force, the policy is currently under review. During this interim period, establishments are temporarily required to maintain traceability only up to the healthcare facility level.
Read the full announcement here:
MDA Circular Notice – Interim Directive on Implantable Device Traceability
Key Highlights
Scope of Reinforcement
While patient-level tracking remains a legal requirement, establishments are currently only required to maintain implantable medical device traceability up to the healthcare facility level during the interim period.
Audit Compliance
Effective 20 April 2026, Conformity Assessment Bodies and the License Unit are required to accept audit reports where implantable device traceability records are maintained only up to the healthcare facility level.
This interim approach applies while the MDA continues reviewing the policy and developing more detailed requirements.
Pending Guidance
The MDA’s Policy Division is reviewing the existing requirements and is expected to issue a formal reference document providing:
- Specific guidance on implantable device traceability requirements.
- Clarification on patient-level tracking expectations.
- A definitive enforcement date for mandatory patient-level traceability.
Stakeholders should continue monitoring MDA announcements for further updates.
Implementation Date
The interim directive is effective from 20 April 2026.
Until further guidance is issued, establishments may maintain implantable medical device traceability records up to the healthcare facility level.
Implications to Clients
Establishments handling implantable medical devices may continue maintaining traceability records up to the healthcare facility level during this interim period.
Companies should nevertheless continue preparing their systems and processes for the eventual enforcement of patient-level traceability requirements.
Stakeholders are also advised to monitor upcoming MDA guidance and reference documents for further clarification on implementation requirements and enforcement timelines.
For Inquiries
For inquiries or support regarding medical device traceability and regulatory requirements in Malaysia, please contact sales@andamanmed.com.