Demystifying the US FDA’s Medical Device Classification System

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Demystifying the US FDA’s Medical Device Classification System

Navigating the complex landscape of medical device regulations can be a daunting task for manufacturers and healthcare professionals. The United States Food and Drug Administration (US FDA) classifies medical devices into different categories, based on risk, intended use, and other factors. Understanding these classifications is crucial for ensuring compliance as well as the safety and efficacy of medical devices.

Approval Pathway of Digital Therapeutics in South Korea

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Approval Pathway of Digital Therapeutics in South Korea

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.

Upcoming Changes in Brazil’s Medical Device Labeling and Artwork Standards: RDC 751 Update for 2023

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Upcoming Changes in Brazil’s Medical Device Labeling and Artwork Standards:  RDC 751 Update for 2023

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.

Good Distribution Practices (GDPs) for Medical Devices in Indonesia

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Good Distribution Practices (GDPs) for Medical Devices in Indonesia

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.

A Deep Dive into Pre-market Clinical Investigation Under the EU MDR 2017/745

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A Deep Dive into Pre-market Clinical Investigation Under the EU MDR 2017/745

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 –

Understanding the Post-market Clinical Investigation Under the EU MDR 2017/745

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Understanding the Post-market Clinical Investigation Under the EU MDR 2017/745

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.

US FDA Approval Pathways for IVDs

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US FDA Approval Pathways for IVDs

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.

Classification

Consultation of Companion Diagnostics (CDx) & Guidance on Procedural Aspect

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Consultation of Companion Diagnostics (CDx) & Guidance on Procedural Aspect

Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment. The Notified Body (NB) would issue the conformity certificate after the assessment is concluded.

The conformity assessment and documents to be submitted depend upon the type of device that is being placed on the market -