Back in November 2019, the Malaysian Federal Government released legislation pertaining to the duties and obligations of medical device establishments in Malaysia. The regulation highlighted the information required to be collected and stored by establishments, such as distribution records, records of complaint handling, mandatory problem reporting, field corrective or preventive action, voluntary recall, and mandatory recall. This regulation shall come into operation on 1 July 2020.
Specifically, as regards to medical device distribution records, the Medical Device Authority (MDA) released a guidance document, MDA/GD/0008, on 4 June 2020 in advance of the requirements coming into effect on 1 July 2020. This ensures that medical devices placed on the market meet appropriate standards of safety, quality, performance and effectiveness and that medical devices are used safely by the public.
Distribution records shall contain the following information:
- Postal address of the consignee(s) in a format that allows physical location to be established together with a telephone number;
- Address of the place of storage of the medical device;
- Identification of a medical device(s); make, class, model number or item description, part number, batch number, and quantity of the devices, including any medical device that is part of a medical device grouping as prescribed in Part II, Second Schedule of Medical Device Regulations 2012 (if applicable);
- Details of the delivery and receipt of the medical device which are traceable to all shipping/delivery documentation information;
- Information and documentation on the disposal of the medical device (if applicable); and
- Any other information as may be required by the Authority.
For implantable medical device, the distribution records shall contain additional information as follows:
- Details of the healthcare facility where the implantable medical device is implanted including the department which conducts the implantation procedure;
- Details of the patient on whom the implantable medical device is implanted or used if possible, to get the information;
- Date of implantation of the medical device; and
- Details of removal of the implantable medical device, if applicable
Distributors and importers in Malaysia, including exporters dealing with the medical devices, shall have correctly documented information in the distribution records. Distribution records shall be retained as follows:
- For 2 years after the date on which the medical device is supplied;
- If the medical device is for export, for 2 years from the date the medical device is shipped out of Malaysia; or
- If the medical device has a projected useful life, for the projected useful life of the medical device as determined by the manufacturer, whichever period is longer.
For implantable medical devices such as pacemakers, defibrillators, and drug infusion systems, establishment shall track all implantable medical device down to patient level in the case of any incident relating to the implantable medical device, FCA, or recall is required to be conducted. If tracking is not possible at the patient level, the establishment shall track the implantable medical device down to the healthcare facility level or keep track of the date of the medical device being put into service or implanted into a patient.
Click here to read the full guidance document on medical device distribution records in Malaysia.