The Health Sciences Authority (HSA) is Singapore's Regulatory agency in the sphere of healthcare products. Importers and wholesalers dealing with medical devices in Singapore should develop a medical device Quality Management System (QMS) that conforms to the requirements of the Good Distribution Practice for Medical Devices (GDPMDS). SS 620: 2016 is the Singapore Standard for Good Distribution Practice for Medical Devices (SS620 GDPMDS).
Post-market surveillance (PMS) is a system through which surveillance of adverse events and malfunctions of health products in the post-market phase are carried out, aimed at recommending the adoption of measures to ensure the protection and promotion of public health.
Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions. Hence, PMS plays an important role in refining the safety and efficacy of medical devices.
You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021. These provisions are designed to offset the negative consequences in the absence of an MRA (Mutual Recognition Agreement) update and to ensure a sufficient supply of medical devices to Switzerland. Let us know more about these amendments.