• PMS Requirements for Medical Devices in Thailand
    September 24, 2021 Medical Devices, Regulatory Affairs

    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.

  • Swissmedic’s New Medical Device Regulations
    July 30, 2021 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.