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).

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.

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.

The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA). They must understand and comply with the US FDA’s regulations to successfully launch their products in the US.

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.

An Overview of Document Registration for Medical Devices in Turkey

The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996. This action, if implemented, will align 21 CFR 820 more closely with ISO 13485:2016, the international consensus standard for devices widely accepted by global Regulatory Authorities. The FDA believes that globally harmonizing the device regulation will help provide consistent, safe, and effective devices, contributing to public health through timely access for patients.

Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices. To meet the comprehensive QMS requirements, there is a need to adapt to the ISO 13485 international standards.

Medical device’s global standard for quality management system gets a long-awaited amendment to a new standard: ISO 13485. However, the new amendment allows the manufacturers, regulators, certification bodies a time window of three years for the transition process. Till then the previous standards ISO 13485:2003 and ISO 13485:2016 will coexist.