Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref. : EIC 111/2/19

6 February 2024

Dear Sirs,

Commercial Information Circular No. 127/2024

US : FDA's Amendments on Quality System Regulation for Medical Devices

The US Food and Drug Administration (FDA) published in the Federal Register (FR) of 2 February 2024 the final rule amending the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonise and modernise the regulation.

2.FDA is revising its medical device CGMP requirements as set forth in the QS regulation by incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485. Through this rulemaking, FDA is harmonising quality management system requirements for medical devices with requirements used by other regulatory authorities.

3.This rule is effective on 2 February 2026 and shall apply to the specified finished devices intended for human use that is manufactured in, or imported or offered for import into the US.

4.For details, please refer to the FR notice at https://www.govinfo.gov/content/pkg/FR-2024-02-02/pdf/2024-01709.pdf.

ENQUIRIES

5.For enquiries concerning the content of this circular, please contact Miss K Y HO at telephone number 2398 5405.

Yours faithfully,

(Miss Kwany KOU)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.