8th November, 2017
On November 1st of 2017, the Medical Device Authority (MDA) released the Draft of a new Guidance Document on the Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education. This Guidance Document came just in time to answer foreign manufacturers and local distributors’ concerns on whether unregistered medical devices are allowed to be imported into Malaysia for non-commercial purposes, for a specified timeline.
This Guidance Document specifies the eligibility of the unregistered medical devices to obtain the Notification of Exemption. A matter to take note is that the Ministry of Health, Malaysia provides exemption for six categories of medical device from section 5 of the Act 737. But for the purpose of this guidance, only two categories are described. Secondly, this guidance also clearly describes the steps to notify the authority and requirements to submit a new application for the import of unregistered medical devices and get the Exemption Letter from MDA.
The applicant can also apply for an extension of demonstration period after the expiry of the first notification and this documents specifies the requirements and steps to follow. An important reminder here is that the notification to the MDA does not exempt the applicant from abiding to any other law or regulations in Malaysia with regards to importing and using an unregistered medical device. The applicant has to keep in mind their duties and responsibilities while the device is in use and the post handling steps to follow for the purpose of demonstration.
This Draft Guidance Document is currently open for public comments until 16th November 2017. To know more on importing and/or supplying unregistered medical devices for the purpose of demonstration for marketing or education, check out the draft Guidance Document available on MDA’s official website.