Malaysia: Medical Device Authority Releases Fifth Edition of Requirements for Labelling of Medical Devices
On 22 June 2022, Malaysia’s Medical Device Authority (MDA) has released The Fifth Edition Guidance for Labeling on Registered Medical Devices. The purpose of the document is to provide guidance to manufacturers and authorised representatives on the content of medical device labelling.
This amendments from the fourth edition to fifth edition are as follows:
Clause No. | Title | Fourth Edition | Fifth Edition |
4.1 | General Requirements | No sample format provided for the label of Malaysian Medical Device Registration Number | A sample format for the label of 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 | Localtion of Labeling | Information to be translated into Bahasa Malaysia shall 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 clause 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. |
4.10 | Instruction for Use | Point (m) “instruction for the user and the patient to report any serious incident that has occurred in relation to the medical device to the manufacturer/ Authorised Representative (AR)” | Deletion of point (m) |
The fifth edition of MDA/GD/0026 also emphasizes the requirements of the contact details of the local manufacturer and AR by including their email, phone number, and website to obtain technical assistance.
To allow all establishment compliance with the labelling requirements as stipulated in this fifth edition of MDA/GD/0026 guidance, the MDA has agreed to give a transitional period until 31 December 2022 via an announcement published on 29 June 2022.
All establishments wishing to import and distribute medical devices to the Malaysian market must meet the labelling requirements “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition” effective January 01 2023.
Additionally, this amendment makes general contents of labelling and instruction of use more feasible with regards to contra-indications, warnings, and precautions, and summary of safety and clinical performance information relevant to the user or patient.
If you have any queries, please get in touch or click the button below.