Malaysia MDA Labelling Guidance 2026 Foreign Manufacturer Update
Malaysia’s MDA updated the Requirements for Labelling of Medical Devices in 2026 by revising Clause 4.8(e) for foreign manufacturers. Under the new requirement, manufacturer name and address remain mandatory, while contact details such as email, phone number, or website address for technical assistance are now optional. The update provides greater flexibility for medical device labelling compliance in Malaysia.
Malaysia’s Medical Device Authority (MDA) has revised the Requirements for Labelling of Medical Devices guidance document in 2026, specifically updating Clause 4.8(e) relating to foreign manufacturer information. The latest MDA labelling guidance clarifies that foreign manufacturer contact details for technical assistance are now optional, while manufacturer name and address remain mandatory.
Key Update to Clause 4.8(e)
The revised requirement states:
4.8(e) Foreign manufacturer: Shall provide the name, address and contact details [email and/or phone number and/or website address], is optional) for technical assistance.
Under this update:
Foreign manufacturer name remains mandatory
Foreign manufacturer address remains mandatory
Contact details for technical assistance are now optional
The optional contact details include:
Email address
Phone number
Website address
Impact of the 2026 MDA Labelling Update
The revision provides greater flexibility for foreign manufacturers when preparing medical device labels for the Malaysian market.
Manufacturers may now simplify packaging and labelling layouts, particularly where space limitations exist or where global labelling harmonization is required across multiple jurisdictions.
Although technical assistance contact details are optional, companies may still voluntarily include them to support communication with healthcare providers, distributors, and end users.
What Industry Stakeholders Should Do
Manufacturers, importers, authorized representatives, and distributors should review their existing medical device labelling to determine whether updates are required following the revised Clause 4.8(e).
Stakeholders are also encouraged to refer to the latest official MDA guidance document to ensure continued compliance with Malaysia medical device labelling requirements.
Related Malaysia Medical Device Regulatory Resources
For additional guidance on Malaysia medical device compliance, stakeholders may also refer to:
External Reference
Official guidance document issued by the Medical Device Authority (MDA):
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us