Malaysia MDA Labelling Guidance 2026 Foreign Manufacturer Update

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:

• MDA Malaysia Medical Device Registration

• Malaysia Medical Device Labelling Requirements

External Reference

Official guidance document issued by the Medical Device Authority (MDA):

• Requirements for Labelling of Medical Devices (7th Edition)

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