Common specifications for medical devices refer to the specific medical purposes for which a device is intended to be used. This includes the type of medical conditions that a device is designed to diagnose, treat, monitor, alleviate, or prevent. It also includes the target patient population, the body part or type of tissue that the device is designed for, and the medical conditions for which the device is intended to be used (e.g., hospitals, clinics, home care settings, etc.).

Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases. With improved patient outcomes, real-time monitoring, greater accessibility and flexibility as well as cost-effectiveness, digital therapeutics has revolutionized the healthcare sector, and worldwide health agencies are currently focusing on regulating this class of devices effectively.

Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.

The Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, registration, post-approval modifications, and revalidation of medical devices in Brazil. ANVISA’s Resolution of the Board of Directors (RBD) No. 751/2022 was recently published and has been effective from March 01, 2023.

In Indonesia, the Good Method for the Distribution of Medical Devices, locally known as the Cara Distribusi Alat Kesahatan yang Baik (CDAKB), is a set of guidelines used in a series of distribution and quality control activities aimed at ensuring that the distributed medical device products meet the requirements for their intended use.

The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations. Clinical investigations are necessary to assess a device’s safety and performance and demonstrate that it meets the requirements of the EU MDR. Under the EU MDR, the clinical investigation has been divided into three (03) components –

As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.

Direct-to-Consumer (DTC) drug advertising has become a favorite topic of discussion in recent years. These advertisements, which are aimed at consumers rather than healthcare professionals, have been credited with increasing patient awareness and demand for certain drugs. However, they have also been criticized for potentially leading to overdiagnosis and overtreatment.

In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.

The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.

Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).