A large number of medical equipment sampling failed!

Recently, the State Food and Drug Administration's newly issued notice on the results of national medical device supervision and sampling shows that the State Food and Drug Administration recently organized a product quality supervision and sampling inspection of 5 varieties including intervertebral fusion devices and semiconductor laser treatment machines, a total of 12 batches.
(Taiwan) The product does not meet the standard requirements
.
The unqualified problems of sampling products mainly include that the external marking of equipment or equipment parts, the accuracy of control devices and instruments do not meet the standard, the surface roughness does not meet the standard, and the total irradiance and central illuminance of the surgical shadowless lamp do not meet the standard.
etc.

_ The bureau has requested the provincial drug regulatory department where the enterprise is located to make an administrative decision in a timely manner and announce it to the public for products that do not meet the standards and regulations found in the sampling inspection
.
The medical device industry is the core resource on the supply side of the medical ecology.
The safety of medical devices is closely related to the health of the people.
In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, relevant departments in China have continued to strengthen supervision and strictly build medical devices.
The security line of defense, the scope of sampling inspections has both national and local levels
.
For example, on April 8, the Food and Drug Inspection Center of the State Food and Drug Administration issued the "Notice of Unannounced Inspection of Medical Devices".
The inspection center organized unannounced inspections of medical device manufacturers from October to December 2021.
7 companies in Beijing have general items that do not meet the requirements of the "Quality Management Specification for Medical Device Production" and related appendices
.
A total of 64 non-conforming items were found in the inspection.
The unannounced inspection varieties included disposable tubular gastrointestinal stapler, disposable anorectal stapler, disposable skin stapler, disposable foreskin cutting stapler, and disposable linear stapler.
Cutting stapler and components, semiconductor laser treatment system, disposable sterile self-destructing syringe with needle, tracheal intubation, disposable negative pressure drainage and wound protection materials, infrared forehead thermometer,
etc.
Not long ago, the Fujian Provincial Food and Drug Administration also conducted a round of supervision and sampling inspection of medical devices.
The inspection found 6 batches of products that did not meet the standards, including medical surgical masks, medical disposable protective clothing, etc.
The unqualified items included microbial indicators, masks Belt, etc.
do not meet the regulations
.
According to the news from the first quarter of 2022 medical device post-market supervision risk conference organized by the Device Supervision Department of the State Food and Drug Administration on April 20, since the first quarter of this year, through in-depth organization and development of special drug safety rectification and medical device risk potential investigations, The quality and safety risks of medical devices have been effectively prevented and controlled
.
The meeting requested that unannounced inspections, quality supervision and sampling inspections, and adverse event monitoring should be fully used in the supervision of medical devices to strengthen the investigation and disposal of potential risks; implement list management of discovered potential risks and sell them one by one to ensure product quality and safety; Continue to follow up on the disposal of potential risks, urge local regulatory authorities to implement their regulatory responsibilities, and promptly investigate and deal with violations of laws and regulations
.
In addition to frequent random inspections, the industry's new policies and standard formulation and revision work are also continuing to advance, forcing the standardized development of the industry
.
For example, from May 1, 2022, the "Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operations" will be officially implemented, and the entire medical device industry will usher in strict supervision; on April 14, the State Food and Drug Administration The "Announcement of the 2022 Medical Device Industry Standard Formulation and Revision Plan Project of the General Department of the State Food and Drug Administration" was released.
The 2022 medical device mandatory industry standard formulation and revision plan project includes 93 standard-setting projects and 23 standard-revising projects
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.