The Medical Device Authority (MDA) has issued Circular Letter No. 1/2026, introducing new requirements under Act 737 governing the procurement of medical devices by healthcare facility institutions in Malaysia. These requirements take effect from 28 January 2026.
The Circular clarifies the regulatory obligations applicable to companies participating in medical device tenders and sets out mandatory documentation requirements for healthcare facilities prior to procurement.
Read the full circular here: MEDICAL DEVICE AUTHORITY (MDA) CIRCULAR LETTER NO. 1/2026 PROCUREMENT OF MEDICAL DEVICE FOR HEALTHCARE FACILITY INSTITUTIONS
Purpose of the Circular
- To enforce compliance with Act 737 for the procurement of medical devices by healthcare facility institutions.
- To clarify the regulatory status and responsibilities of companies participating in medical device tenders.
- To strengthen post-market control and accountability for medical devices supplied through tenders.
Scope of Application
This Circular applies to companies participating and succeeding in medical device tenders, and considered to be placing medical devices in the Malaysian market.
Key Highlights
Classification of Tenderers
- Tenderer is a company or representative of a supplier company participating in procurement activities for supply tender to the Government of Malaysia or private institutions..
- Such companies are deemed to be placing medical devices in the market under Act 737.
Regulatory Requirements for Tenderers
All tenderers must:
- Hold a valid Establishment Licence for medical device distribution.
- Implement a Quality Management System in accordance with GDPMD requirements.
- Assume full post-market responsibilities, including incident reporting and implementation of corrective actions.
Procurement Requirements for Healthcare Facility Institutions
Prior to procurement, healthcare facility institutions must obtain the following from tenderers:
- A valid Establishment Licence (Distributor).
- A valid Medical Device Registration Certificate.
- A Letter of Appointment issued by the Authorized Representative (AR) or the original establishment.
Revocation of Previous Circular
With the issuance of this Circular, Circular Letter No. 2/2016 (Revision 2) is revoked.
Implications to Clients
Importers and distributors in Malaysia should ensure that:
- A valid MDA Establishment Licence is in place.
- GDPMD certification requirements are fully met.
- A valid Letter of Appointment from Andaman Medical is obtained prior to any distribution activities.
Effective Date
28 January 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.
