FDA published a Quality Management System Regulation (QMSR) final rule on February 2, 2024 to revise the current good manufacturing practice (CGMP) requirements for medical devices in the Quality System (QS) Regulation (21 CFR Part 820).
FDA amends Part 820 to incorporate the QMS requirements of ISO13485 as references. Replacing the Quality System(QS) with the Quality Management System Regulation(QMSR) harmonizes it with other regulatory authorities. The FDA says it can save time and money by eliminating redundant regulatory requirements and barriers to market access.
The major revisions to QMSR are as follows.
1) Integrate ISO13485:2016 and ISO9000:2015 Paragraph 3 into Version Reference
: The amount of material published in the CFR(Code of Federal Regulations) will be reduced and will have the same effect as the language specified in the regulations.
2) Modification of 21 CFR part4 to clarify Medical Device Quality Management System (QMS) requirements for composite products
To apply QMSR, the FDA determined that two years is sufficient for companies to adjust internal processes and procedures, make appropriate changes within the organization, and update documents through QMSR, and announced the effective date as February 2, 2026.
Please refer to the link below for more information.
QS Regulation/Medical Device Current Good Manufacturing Practices
Good Manufacturing Practices (GMP) / Quality Systems (QS) Regulation
www.fda.gov
If you have any questions about medical device,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net