As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards. Here is what you need to know about the US FDA’s inspections and enforcement actions and how to prepare for them.

Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent. This blog will provide a comprehensive guide on why you need a China agent, their key responsibilities, and the process of appointing them for medical device registration in China.

What is Data Privacy in Healthcare?

Healthcare data includes technologies and systems used for creating health information that is accessible to patients and healthcare providers. It allows doctors to access vital patient information and enables hospitals and other physicians to protect patient data and build trust with patients.

In the ever-evolving world of healthcare, the development and introduction of  new medical devices play a pivotal role in enhancing patient care and advancing medical science. However, before such innovative devices can reach healthcare professionals and patients, they must achieve compliance with a comprehensive Regulatory framework. In India, securing a manufacturing or import license for new medical devices is a multifaceted process that involves compliance with stringent rules and regulations.

The advancement of medical devices has revolutionized patient care and treatment outcomes.

Literature reviews play a crucial role in the clinical evaluation of medical devices and In Vitro Diagnostics (IVDs) throughout their entire lifecycle. These reviews enable researchers to examine previous studies, build upon existing knowledge, and contribute meaningfully to their respective fields. However, adhering to traditional approaches in a literature review can be time-consuming and arduous, particularly considering the evolving needs and demands of the medical field. This can lead to missed opportunities and incomplete analysis.

Brazil, the largest economy in Latin America (LATAM), is also the most promising medical device market in the region. The medical device market in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, which came up with a new resolution titled RDC 751, effective from March 01, 2023.

Introduction

The US Food and Drug Administration (USFDA) has proposed the harmonization of the 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for medical devices in accordance with the International Organization for Standardization (ISO) 13485:2016.

As digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, achieving Regulatory compliance can be a complex and arduous task. Thus, startups must adopt suitable strategies that will help them navigate the ever-changing Regulatory landscape. This blog outlines ten (10) strategies that digital health startups can follow to ensure compliance, and in turn, successful continuation of operations. Let us now explore the strategies in further detail: