Post the Brexit scenario, the Regulatory landscape for medical devices underwent a profound metamorphosis, impacting manufacturers who were aiming to introduce their products into the United Kingdom (UK) market. As the UK exited from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking.

In the ever-evolving healthcare landscape, personalized medical devices have emerged as groundbreaking, tailoring treatments to individual patients based on their unique characteristics. This shift toward personalized care has given rise to a new generation of medical devices that are designed to meet specific patient needs.

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.

The current Regulatory scenario for medical devices in the UK is governed by the Medical Device Regulation 2002 (SI. 2002 No. 618, as amended), also known as the UK MDR, 2002. This framework was originally based on the European directives, but following the UK’s exit from the European Union (EU), there have been changes to how medical devices are regulated in Great Britain (GB), comprising England, Wales, and Scotland.

The pharmaceutical industry is a complex and highly regulated field where patient safety and product integrity are paramount. The packaging of pharmaceutical products is a critical element of this industry, as it ensures that medications remain effective and safe from the moment, they leave the manufacturer until they reach the patient's hands.

Submitting a Marketing Authorization Application (MAA) to multiple Regulatory authorities can be a complex and time-consuming process, especially when it involves submitting the same Active Substance Master File (ASMF) to each authority. This is because different Regulatory authorities may have different requirements for ASMF submissions.

Introduction

The In Vitro Diagnostic Medical Devices Regulation (IVDR) ensures the safety and efficacy of In Vitro Diagnostic (IVD) medical devices, which include test kits, reagents, and equipment for diagnosis and monitoring of diseases. To place an IVDR medical device in the European market, manufacturers must obtain CE marking.

The South Korean pharmaceutical industry is one of the most dynamic and innovative industries in Asia. The country is strongly committed to Research and Development(R&D), and its Regulatory framework is designed to facilitate the development and approval of new drugs.

When a foreign establishment engages in the production of a medical device imported into the United States (US), it is mandatory to designate a US agent for that establishment. The US agent serves as the point of contact for any US Food and Drug Administration (US FDA) communication related to the foreign registered facility.

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.