Temporary importation of medical equipment, there is a way out!

On 18 October 2023, NMPA released NMPA Integrated Division Publicly Solicits Opinions on <Management Requirements for Temporary Import and Use of Clinically Urgent Medical Devices in Healthcare Institutions (Draft for Public Comment)>, which is now open for public comment, and feedback can be provided by email before 15 November.

In order to do a good job of revising the supporting documents of the Regulations for the Supervision and Administration of Medical Devices, NNMPA has drafted the Management Requirements for the Temporary Import and Use of Clinically Urgent Medical Devices for Medical Institutions (Draft for Public Comments) and other documents, which are now open to the public for comments.

#01 Feedback notes

Time：By November 15, 2023

Methods: Relevant opinions are sent to ylqxzc@nmpa.gov.cn by E-mail with the subject line marked “Opinions on urgent import and use “.

#02 Applicable Conditions

This management requirement applies to medical devices temporarily imported and used by medical institutions due to special clinical needs of patients, which have been listed abroad but have not been approved for the same variety of products in China, and are used for the prevention and treatment of serious life-threatening diseases, and there are no effective treatment or prevention measures in China, but does not include equipment that should be included in the management of large-scale medical equipment configuration licenses.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Article Source：NMPA，Device Market

Translated & edited ： Bradyknow