Post-market clinical follow-up (PMCF) is one of the post-market surveillance methods that the SFDA enforces in Saudi Arabia. It is a standard international practice to approve medical devices. PMCF provides clinical evidence demonstrating conformity to essential requirements, including assessing the benefit-risk ratio.
However, it’s essential to recognize that demonstrating conformity assessment is a pre-market element influencing the decision to place the medical device in the Saudi market. In certain situations, manufacturers fail to detect risks that become visible only after long-term use of the device. Therefore, manufacturers must implement a proper post-market surveillance plan to investigate and assess the risks after marketing the product.
The investigation aims to collect and accumulate real-world data that addresses patient safety and the device’s effectiveness at the post-market phase through systematic and appropriate post-market clinical follow-up studies.
In these circumstances, the decision is evaluated at the pre-market phase, based on identifying possible residual risks and uncertainty on long-term clinical performance that could affect the benefit/risk ratio.
The decision in these circumstances is evaluated at the post-market phase, which is undertaken based on a triggering in the adverse events reporting and any other means of the post-market activities. In these situations, the SFDA post-market clinical evaluation team will take the responsibility of evaluating the medical device in question, and in case there is insufficiency in the clinical data that facilitates withdrawing clinical evidence, the team might request PMCF studies that address the unanswered question(s) that may impact the device benefit/risk ratio.
In this section, we will clarify the steps undertaken by SFDA to identify the issue to be complemented with PMCF studies and the SFDA expectations afterwards. Following the identification of the issue, manufacturers and their Saudi-authorized representatives will be responsible for conducting the study in a manner that addresses the unanswered question(s).
First, when PMCF studies are needed during the pre-market evaluation, the decision will be made during the pre-market approval process. During the medical device registration (MDMA), the applicant will be requested to provide a PMCF plan specially designed for the Saudi market.
Secondly, SFDA may identify issues appropriate for PMCF studies during a device’s life cycle management. Such issues may be identified through various sources, including analysis of adverse event reports, a recall or corrective action, post-approval data, review of pre-market data, reports from other governmental authorities, or review of scientific literature.
Whenever SFDA identifies a potential issue for a medical device that may warrant PMCF studies, an order will be issued to target the corresponding manufacturer and its AR in Saudi Arabia. Such an order should be dated, assigned a number, and clearly describe the needed clinical evidence. On the other hand, a manufacturer must submit a PMCF plan within 30 days of receipt of the PMCF order and commence the study not later than 15 months after the date SFDA issues the PMCF order.
The study should:
The data and conclusions derived from the PMCF study provide clinical evidence to support the post-market surveillance program and input into the clinical evaluation process. This may result in the need to reassess whether the device continues to comply with the Essential Principles. Such assessment may result in corrective or preventive actions, for example, changes to the labelling/instructions for use, changes to manufacturing processes, changes to the device design, or public health notifications.
We at PharmaKnowl provide experienced support in SFDA PMCF implementation in Saudi Arabia. We help with:
The design of the PMCF plan for Saudi Arabia is a critical step since it defines the scope and the type of protocols that might implicate the applicant in unnecessary scope, hence costs and timelines. For guidance and consultation, feel free to contact us or request an exploratory meeting.
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