The Medical Device (Exemption) Order of 2016 states that medical devices intended for personal use are exempted from the requirement for registration of medical device under Section 5 of Act 737

The following conditions must be met before medical devices for personal use can be imported or purchased, including through online platforms:

1. only for home-use medical devices.
2. the medical device is for own use or the use of immediate family.
3. all labels and labelling information that comes with the medical device shall be retained.
4. quantity for medical device shall be appropriate according to the type of the medical device.
5. no same or similar medical device(s) is/are registered in Malaysia; and
6. to obtain a formal prescription or letter of recommendation on the medical device(s) from a registered healthcare professional upon request from the Authority.
7. not intended for the use of healthcare practitioners on patients.

Upon request, the Authority may provide a letter confirming to the imported medical device's compliance with the definition and requirements of personal use. An application and related documents in accordance with Annex C of Importation of Personal Use Medical Devices Declaration Form may be submitted to the Authority for this purpose. The importation of medical device for the purpose of personal use is also exempted from the requirements of import permit under Customs (Prohibitions of Imports) Order 2023.

 

Work With Us!

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Contact us today here to unlock your medical device potential.

 

 

References:

IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE