Home About Qualtech NEWS MALAYSIA: NEW GUIDANCE DOCUMENT MDA/GD/0051 ON NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE - August, 2019
MALAYSIA: NEW GUIDANCE DOCUMENT MDA/GD/0051 ON NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE - August, 2019

August 12, 2019

The importation, exportation, or placement of a medical device in the Malaysia market requires the medical device to be registered under Medical Device Act 2012 (Act 737). The Circular Letter of Medical Device Authority No. 4 Year 2018 exempts medical devices that are for export only from registration requirements and only require notification to the Authority. So, based on this, MDA has issued a new guidance document MDA/GD/0051 which details the necessary information to take note of while applying for an “Acknowledgement on Notification” letter from MDA for these export only medical devices.

An “Acknowledgement on Notification” letter issued by MDA then permits the device to be exported. The applicant for this notification shall be a licensed establishment or contract manufacturer/ authorized exporter who is responsible for exporting the medical device. The notification shall be made according to the Flowchart in Annex A using the Form as in Annex B of this Guidance Documents. The applicant shall submit application form by email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

It is to be noted that the applicant shall submit a notification before exportation of the first shipment, so an “Acknowledgement on Notification” will be issued before exportation of the medical device. Any additional information, particulars or documents required by the authority shall be provided by the applicant within 14 days from the date of request by the authority. Inability of the applicant to produce documents when requested by the Authority may result in the cancellation of the application and applicant shall apply new application.

 

References:
New Guidance Document MDA/GD/0051 On Notification Of Export Only Medical Device


Tags:

Export-only medical devices; Acknowledgement of Notification 

 

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Home About Qualtech NEWS MALAYSIA: NEW GUIDANCE DOCUMENT MDA/GD/0051 ON NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE - August, 2019