On June 2020, Medical Device Authority (MDA) of Malaysia has published a guidance document to set a framework for the management of medical device distribution records.
The guidance document is created for establishments which include exporters who are dealing with medical devices.
Pursuant to the Medical Devices Act 2012 (Act 737), licensees are required to continuously monitor the safety and performances of the medical devices in the market vigilantly. As such the document will enable proper management and maintaining of the distribution records.
The vital information that should be contained in the distribution record are such postal address of the consignee(s) along with a telephone number, the address of the place of storage, identification of medical device, class, make, part number, model number, batch number, shipping and delivery documentation information and information pertaining to the disposal of the medical device.
As for the implantable medical device, among the important information that should be included in the distribution records are such as the details of a healthcare facility, the patient of whom the device is implanted, the date of the implantation, and details of the removal of the medical device.
The record of the above information will allow the withdrawal of the medical device in the market in a complete and rapid manner.
The record of the medical device should also be maintained vigilantly in terms of its adequacy and eligibility and ensured that there are no obsolete records. The medical device should also contain appropriate identification data in the event they are retained for any purpose.
Please refer to the link below to access the said guidance document:-
https://portal.mda.gov.my/documents/guidance-documents/1428-distribution-records-60-60-3june2020-1/file.html