Post-market Surveillance (PMS), in the context of Quality Management Systems (QMS), refers to the systematic approach to collecting, recording, and analyzing data on the quality, performance, and safety of a medical device throughout its entire lifecycle, actively and continuously. This process is an integral part of a manufacturer’s QMS. It is essential for ensuring that a medical device continues to meet its intended purpose and remains compliant with the Essential Principles of Safety and Performance.

Clinical trials form a critical phase in the development and approval of medical devices. They provide the necessary evidence to demonstrate the safety and efficacy of a device before it can be marketed. The United States Food and Drug Administration (US FDA) sets stringent requirements for conducting clinical trials to ensure that the data collected are reliable and that patient rights are protected.

Post-market Surveillance (PMS), in the context of Quality Management Systems (QMS), refers to the systematic approach to collecting, recording, and analyzing data on the quality, performance, and safety of a medical device throughout its entire lifecycle, actively and continuously. This process is an integral part of a manufacturer’s QMS. It is essential for ensuring that a medical device continues to meet its intended purpose and remains compliant with the Essential Principles of Safety and Performance.

Instructions for Use (IFUs) for medical devices are documents that provide essential information and instructions on how to use the devices safely and effectively. They are typically supplied by the manufacturer and form an integral part of the device’s Regulatory requirements.

Reprocessing refers to the method through which you can reuse medical devices safely and effectively. The European Union Medical Device Regulation (EU MDR) 2017/745 describes the word “reprocessing” as exclusively used for single-use devices, while it describes the reprocessing of reusable devices as “the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilization appropriate to the member state or the member states in which the device has been placed on the market. “

In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO), is a temporary license that allows a manufacturer to conduct tests on their medical device before they can obtain a permanent license for it. The test license allows the manufacturer to conduct clinical trials and other tests on the device and gather data on its safety and efficacy. The CDSCO requires the manufacturer to obtain this license to ensure that the device is safe and effective for patients’ use.

IVD devices are essential for healthcare professionals in providing accurate and timely diagnosis, monitoring, and treatment of diseases, leading to improved patient outcomes and better public health. IVD devices are classified into different classes based on their level of risk to the patient and the complexity of the device. The classification system for IVD devices varies depending on the region or country.

An operation manual is in many ways referred to as labeling, Instructions for Use (IFU), or a user guide. It is a document that is instrumental in achieving the safety of a medical device and illustrates the general ways to use or operate a medical device.

In effect from March 1, 2023, the technical dossier must be planned as described in the Brazilian Health Regulatory Agency, or the Agência Nacional de Vigilância Sanitária (ANVISA)’s   new medical device regulation, RDC 751/2022. This blog provides you with an insight on technical dossier Regulatory compliance in accordance with the new resolution.

Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.

According to the Therapeutic Goods (Medical Devices) Regulations, 2002, a custom-made medical device is defined in the following terms: