Regulatory Background
A Circular Letter of Medical Device Authority No.1 Year 2026 has come into full effect as of 28 January 2026. The circular introduces mandatory licensing requirements for all medical tenderers participating in any new tender or subsequent tender activities.
Exemption Categories
However, exemptions will be granted to the tenderers who fall under following categories to ensure smooth administration of government and private procurement activities, as well as continuity of medical supply. These exemptions apply only to tenderers engaged in activities prior to 28 January 2026:
| Category | Tenderer's type |
| Category I | Tenderers who are currently supplying medical devices under tenderers awarded |
| Category II | Tenderer who has received a Letter of Acceptance (LOA) or Tender Award |
| Category III | Tenderers who have participated in tender processes arising from tender advertisements |
Nevertheless, this exemption remains valid only until the existing contract period expires or the relevant tender activity is completion.
Compliance Requirement
All tenderers seeking to participate in any new or upcoming tenders shall hold a valid establishment license in accordance with Section 15 of the Medical Device Act 2012 (Act 737), the Medical Device Regulations 2012, and Circular Letter MDA No.1 Year 2026.
Enforcement
Industry stakeholders are reminded that failure to comply with these requirements constitutes an offence and may result in legal action by the MDA.
With the enforcement of mandatory licensing requirements for medical tenderers, companies involved in procurement activities in Malaysia should ensure that a valid establishment license is in place before participating in new tenders.
Qualtech Consulting Corporation supports medical device companies in obtaining establishment licenses and ensuring compliance with Medical Device Authority (MDA) requirements.
Contact us to ensure your eligibility for upcoming tender opportunities in Malaysia!
Reference
Implementation Of Medical Device Authority (PBPP) Circular No.1 2026