Guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.

MALAYSIA IMPLEMENTS ADVERSE EVENTS REPORTING REQUIREMENTS FOR MEDICAL DEVICES

On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.

The new Regulations are very similar to the ASEAN Medical Device Directive’s (AMDD) guidance, however the MDA expands on the procedures and defines Malaysia-specific record keeping requirements and penalties. The new Regulations detail the criteria for reportable AEs, the information needed to maintain and support an effective and timely recall and the process of field corrective and/or preventive actions. 

It is the responsibility of the Malaysia Authorized Representative listed on a product’s registration certificate to communicate with the Ministry of Health for all post-market vigilance issued on behalf of the legal manufacturer.

Recalls

The MDA categorizes recalls into 3 categories: Class I, Class II and Class III, with Class I being the highest risk. For Class I recalls, the establishment must notify the Authority and all persons affected by the recall no less than 48 hours before the recall is made. For Class II recalls, the notice must be made no less than 3 days before and for Class III, no less than 5 days.

Adverse Event Reporting

The MDA has aligned their reporting process with the AMDD and requires establishments to immediately conduct an investigation upon identifying an AE. Establishments must submit a mandatory report in order to determine if a Field Safety Corrective Action (FSCA) is required. Manufacturers are able to perform FSCAs at any time, but must notify the MDA beforehand and then provide a report to formally close out the issue. After the mandatory report, the establishment is required to submit an investigation report within 30 days, identifying the steps they have taken to correct the issue. Like the AMDD, the MDA reserves the right to require the establishment to take additional steps to protect the public’s health, which includes mandatory recalls. 

Record Keeping

Record keeping is a fundamental requirement in both the AMDD and the MDA’s guidance. Record keeping is a crucial component of an effective Post-Market Vigilance system, as it ensures establishments can quickly identify where their products are in the case of a recall or corrective/preventive action. Both the AMDD and the MDA require complaints to be maintained for at least 5 years past the useful life of the product. Additionally, distribution records must be kept for at least 2 years or for the duration of the projected useful life as stated by the manufacturer in the technical documentation. Distribution records must contain the consignee, the specifications of the device, the place of storage, details about the delivery and receipt, and details about the disposal of the device. In addition to these requirements, the MDA stipulates that establishments marketing implantable devices maintain information on the healthcare facility that performed the procedure, the details of the patient, the date of implantation and details of removal of the implant, if applicable.

AMDD & MDA Record Keeping Requirements
AMDMDA
Complaint RecordsUseful Life + 5 yearsUseful Life + 5 years
Distribution RecordsProjected Useful Life of the MD (or) 2 years after the MD is shipped2 Years after the MD is placed on the market (or) 2 years after the MD is shipped (or) for the Projected Useful Life

The ASEAN Medical Device Directive was signed in 2015 with the aim of harmonizing medical device regulations across the 10 participating nations of Indonesia, Malaysia, the Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar and Cambodia. Creating synergies across different areas of the regulations makes it easier for citizens in these countries to gain access to medical devices. One of the most important synergies stemming from the AMDD was the Common Submission Dossier Template (CSDT), which allows manufacturers to use similar documentation when seeking approval in each ASEAN country.

The MDA also recently released additional information outlining the requirements for when an Authorized Representative or Manufacturer goes out of business. 

Asia Actual is available to answer questions about this new guidance or register and maintain compliance for your medical devices as Malaysian Authorized Representative. Contact us to arrange an initial conversation.