New Post Marketing Surveillance procedures for Combination Products in Malaysia
The Malaysian Medical Device Authority (MDA) has released the 4th edition of Guidelines for Registration of Drug-Medical Device and Medical Device-Drug Combination Products on 25 October 2021. The main changes are the inclusion of new Post Marketing Surveillance procedures for Combination Products in Malaysia namely the management of incidents involving registered combination products by the industry.,
The main objective of post-market activities is to ensure that a registered Combination Product is safe and effective for use. It requires the manufacturer, importer, distributor or authorized representative to report incidents to the MDA or the National Pharmaceutical Regulatory Agency (NPRA) by following the process below:
1)All incidents that have caused user/patient harm shall be reported to the relevant agency. The incident reporting form for combination products shall be used (refer to Appendix 7)
2) The relevant agency receiving the incident report shall determine the assessment of the ‘nature of incident’.
- The assessment of the ‘nature of incident’ will be notified to the relevant agency based on a the registered combination product:
- whether they are Medical Device-Drug Combination Product (MDA as the primary agency, Device issue) or
- Drug-Medical Device Combination Product (NPRA as the primary agency, Drug issue)
- or notify both agencies concurrently (Device and Drug issues) in the event where the nature of the incident cannot be determined as stipulated in Table 2 of Chapter 7 on Post Marketing Activities.
3)The investigation report shall be submitted to the relevant agency as in Table 2, within 30 calendar days, or within a timeframe as directed by the agency.
4)The primary agency shall provide regulatory instruction when deemed necessary, and the company shall provide a follow-up report on the action that has been taken within a timeframe as directed by the agency. The report is considered accepted if no feedback is received from the primary agency within 45 calendar days and no further action is needed.
5)The company shall provide a response to the complainant within an agreed timeframe after completion of the investigation or following the standard operating procedure that is in place.
All notification of incident and investigation reports shall be submitted via e-mail to the relevant agency as stipulated in Section 7.2.3.
The reporting timelines are categorized below:
For events occurring in Malaysia (Local Event) if
- Related to the failure of the product or a deterioration in its effectiveness, or any inadequacy in its labelling or in its instructions for use, the timeline to submit notification/initial report is within 30 days from the discovery;
- Has led to the death or serious deterioration in the state of health of a patient, user or other people, or could do so were the incident to recur, the timeline to submit notification/initial report is within 10 days from the discovery;
- A serious threat to public health, the timeline to submit notification/initial report is within 48 hours from the discovery;
For events occurring outside Malaysia (Foreign Event), if
- An individual incident report, there is no requirement to submit a notification or an initial report on a routine basis (*For medical devices: only if the medical device is registered in Malaysian market);
- Notification of any significant safety issue such as new information impacting on risk(s) benefit profile of the product including international regulatory decision or action, the timeline to submit notification/initial report is no later than 3 days;
- Withdrawal/suspension of registration in any country, the timeline to submit notification/initial report is within 24 hours from the discovery.
Other minor changes in these Guidelines (4th edition) are below:
- Table 4 details the documentation requirements for the ancillary medical device dossier (a medical device where the main mode of action is due to the device and so require MDA assessment).
- Appendix 3 provides a checklist for Submissions via Application Form to obtain an Endorsement Letter of Ancillary Component for the registration of Combination Products.
Click here for the full Guidelines of Registration of Drug-Medical Device and Medical Device-Drug Combination Products by the MDA.