The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR). The US FDA QMSR now aligns more closely with the ISO 13485:2016, the international standard for medical device Quality Management System (QMS).

In the ever-evolving healthcare landscape, personalized medical devices have emerged as a groundbreaking approach, tailoring treatments to individual patients based on their unique characteristics. These include devices that are custom-made or personalized to be adaptable to the patients’ solutions.

21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.

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.

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.

21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.

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.

The medical device industry in Korea has been growing rapidly. This growth is a testament to the quality and innovation of medical devices manufactured in Korea, which are increasingly being exported globally. A critical factor in determining the safety and efficacy of Korean devices is their adherence to Korean Good Manufacturing Practices (KGMP), as recommended by the Ministry of Food and Drug Safety (MFDS).

Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.

A quality agreement is a critical document in a medical device Quality Management System (QMS). The document should specify the responsibilities of various parties involved in activities that impact product quality, safety, and efficacy. It is to be signed with suppliers and outsourced service providers such as contract manufacturers, key medical device part suppliers, and entities like authorized representatives, importers, and distributors to ensure compliance with the Regulatory standards.