The fifth edition of the MDA/GD/0026 emphasizes the need for a local manufacturer and AR contact information, such as email, phone number, and website in the labelling for the user to obtain technical assistance. Table 1 below therefore shows the comparison between the previous and current guidelines.
To allow all establishments to comply with the labelling requirements outlined in this fifth edition of the MDA/GD/0026 guidance, the MDA grants a transitional period until December 31, 2022.
All establishments wishing to import and distribute medical devices into the Malaysian market must comply with the labelling requirements outlined in the "Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition," which will take effect on January 1, 2023.
Tabel 1: Comparison between Fourth and Fifth Edition:
Section |
Title |
Fourth Edition |
Fifth Edition |
4.1 |
General Requirements |
There is no sample format for the Malaysian Medical Device Registration Number label. |
A sample format for the label of the Malaysian Medical Device Registration number is provided. Examples of the format allowed: i. MDA Reg. No. xxxxxxx ii. Registered with MDA GXXXXX iii. Registration No. Gxxxxxxx iv. Gxxxxxxx v. Malaysia Reg. No. XXXXXXX vi. Medical Device Registration No. XXXXXXX vii. MDA GXXXXX |
4.5 |
Location of Labeling |
Information to be translated into Bahasa Malaysia shall be made next to the English version; or the location of the translation may be decided through a risk assessment exercise that shall be submitted during registration. |
For information that are provided on the label, Bahasa Malaysia translation shall be provided on the label itself. |
4.8 |
General Contents |
(a) Details of medical device to enable user to identify it, which include name (brand and name of the device), identifier and model. |
(a) Details of medical device to enable user to identify it, which include name (brand name, generic name and specified name) of the device, model and identifier; |
4.8 |
General Contents |
(i) Any decommissioning or disposal information (infection or microbial hazards, environmental hazards; physical hazards). |
(k) Any decommissioning or disposal information, if applicable and based on risk assessment (for example: infection or microbial hazards, environmental hazards; physical hazards). |
4.8 |
General Contents |
No section of 4.8.2 and 4.8.3 |
Addition of: 4.8.2 The information in 4.8.1 (f), (g), (h) & ( i) and other necessary information may be provided, in the form of insert or other types of labelling, after applying risk management as according to ISO 14971. 4.8.3 For all labeling information, requirements on MDA/GD/0032, Code of Advertisement (COA) shall be observed.
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References:
Requirements for Labelling Of Medical Devices