The Medical Device Authority (MDA) released guidance for the importation of personal use medical devices and the guidance is applied to all home-use medical devices that fall under the definition as defined in MDA/GD/0006.
As generally informed, medical device importation must undergo legal registration and comply with the requirements of MOH before being able to enter the Malaysian market. However, the exemption is granted under Medical Device (Exemption) Order 2016 for medical device registration and establishment license requirements for personal use of medical devices.
The exempted personal use medical devices cover all importation modes either by land, sea, or air. For those personal use medical devices to be placed in the market, it does not include the usage of clinical research or for performance evaluation of the medical devices.
All medical devices for personal use that is imported or purchased (including online purchase) may be exempted from the requirement for medical device registration under Section 5 of Act 737 and establishment license under Section 15 of Act 737, if fulfilled the following requirements:
The medical device is applicable only for home use
The medical device is owned only for own or immediate family use
The medical device’s labeling information should be retained
The quantity of medical devices to own shall be appropriate according to the type of medical devices
There are similar or the same medical device types registered in Malaysia
Acquire formal prescription or letter of recommendation on the medical devices from the registered healthcare professional, upon requests from the Authority
The medical devices are not specified under professional use medical devices (stethoscope etc)
The medical devices are not authorized under MOH to be handled by professionals only (injectable dermal filler etc)
Source: Medical Device Authority (MDA)
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