The Medical Device Authority (MDA) has announced a revision to the requirements for foreign manufacturer contact details under the Guidance Document MDA/GD/0026: Requirements for Labelling of Medical Devices.
The update forms part of the latest revision to Malaysia’s medical device labelling guidance and applies to both general medical devices and In-Vitro Diagnostic (IVD) medical devices.
Read the full announcement here:
MDA Announcement – Revision to Foreign Manufacturer Contact Details Requirement
Purpose of the Update
The revision updates the requirements concerning the contact information that foreign manufacturers should provide on medical device labels and/or accompanying documentation.
The change is reflected in the May 2026, 7th Edition of MDA/GD/0026 and provides greater flexibility in how foreign manufacturer contact details are presented for technical assistance.
Scope of Application
The revised requirement applies to medical devices marketed in Malaysia, including general medical devices and IVD medical devices subject to the labelling requirements under MDA/GD/0026.
It is relevant to foreign manufacturers, Authorized Representatives (ARs), importers, distributors, and other establishments responsible for ensuring compliant medical device labelling in Malaysia.
Key Highlights
- Revision of labelling requirements related to foreign manufacturer contact information on medical device labels and/or accompanying documentation.
- Changes on Clause 4.8 General of contents labelling, foreign manufacturer are required to ensure that the foreign manufacturer’s contact details are complete, accurate, and maintained in accordance with the updated MDA guidance requirements:
| MDA/GD/0026 May 2026 7th Edition | MDA/GD/0026 May 2026 7th Edition |
| Clause 4.8 General of contents labellinge) Local manufacturer and AR: Shall provide the name, address, and at least one contact detail [email and/or phone number and/or website address] is compulsory to facilitate technical assistance. Foreign manufacturer: Shall provide the name, address and website address for technical assistance | Clause 4.8 General of contents labellinge) Local manufacturer and AR: Shall provide the name, address, and at least one contact detail [email and/or phone number and/or website address] is compulsory to facilitate technical assistance. Foreign manufacturers shall provide the name and address on the label. Contact details i.e: email and/or phone number and/or website address are optional for technical assistance. |
Implementation Date
The revised requirement is effective immediately.
Companies marketing medical devices in Malaysia should therefore refer to the May 2026, 7th Edition of MDA/GD/0026 when reviewing or preparing medical device labelling.
Implications to Clients
Manufacturers, Authorized Representatives, importers, and distributors should review their current labelling information against the revised MDA requirements.
In particular, companies should confirm that foreign manufacturer information is presented in accordance with the latest guidance and determine whether any existing labels, IFUs, packaging artwork, or regulatory documentation require revision.
Aligning affected materials with the updated requirements can help minimize potential regulatory non-conformities during submission reviews and post-market activities.
For Inquiries
For inquiries or support regarding medical device regulatory requirements and labelling compliance in Malaysia, please contact sales@andamanmed.com.