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On March 24, the State Food and Drug Administration issued the "Announcement on Adjusting Some Contents of the <Medical Device Classification Catalog> (No.
25 of 2022)".
It is worth noting that liquid and paste dressings (non-sterile ones) will be provided by I.
Class medical devices are adjusted to Class II medical devices.
How much impact will this have on the medical device industry? 1.
What are some common liquid/paste dressings that you can't think of? Masks, liquid band-aids, scar patches, burn/wound dressings, cold headbands/eye masks, spray dressings, wound care ointments are all liquid/paste dressings
It is worth noting: Medical dressings, medical cold compresses, also known as facial cold compresses, according to the old "Medical Device Classification Catalog", these products are managed as first-class medical devices
According to the 2022 new version of the "Medical Device Classification Catalog", this product is managed as a second-class medical device
Reasons for the adjustment of Class I to Class II medical devices.
There is a huge difference between the first class of medical devices and the second class of medical devices in applying for the administrative license for product qualification.
According to relevant regulations, the first class medical device products are subject to filing management.
You only need to provide relevant information, no clinical evaluation is required, and the certificate can be issued if the information is passed, and the inspection will be carried out within three months after the certificate is issued
The second category of medical devices is subject to registration management, and relatively detailed information including clinical evaluation data needs to be provided.
After on-site inspection of the medical device quality management system assessment, the certificate can be issued
Due to the lax filing application of the first category of medical device products, it is relatively loose, so in the huge market, many manufacturers take risks, in order to obtain more benefits, regardless of product safety, add prohibited ingredients without authorization, or take advantage of loopholes Playing word games and walking into a gray area, the actual situation of the product is inconsistent with the situation at the time of declaration
Impact on medical device companies 1.
Medical cold compresses, facial masks, etc.
cannot be registered as "physical cooling equipment", and the intended use is limited to "local cooling for fever patients
It is only used for intact skin on the body surface", and " medical cold compress, medical cold compress headband, medical cold compress eye mask, cold compress gel" has been deleted from the product name example
Physical cooling equipment cannot contain these components.
Physical cooling equipment cannot contain traditional Chinese medicines, chemical drugs, biological products, disinfection and antibacterial components, natural plants and their extracts, etc.
to play a role in pharmacology and immunology.
, Metabolic components or components that can be absorbed by the human body
(From the "List of Prohibited Ingredients in Some Class I Medical Device Products") 3.
Liquid dressing products cannot promote the following functions.
The "Notice on Carrying out the Standardization of the Filing and Clearing of the First Class Medical Devices in China" (hereinafter referred to as the "Notice"), which mentions the key inspection items for liquid dressing products, such as liquid dressing products: can not claim to have "antibacterial" "disinfection" "Promoting wound healing", "promoting local tissue growth", "reducing epilepsy scar formation", etc.
; cannot claim to be used for the care of chronic wounds and deeper wounds; liquid dressings, spray dressings, wound care ointments, liquid wound dressings, wounds The relevant ingredients added in the posted product formula cannot be absorbed by the human body, etc.
Impact on the filer According to the “Administrative Measures for Registration of Medical Devices” and “Announcement on the Announcement of Application Materials for Medical Device Registration and the Format of Approval Certificates”, medical device registration applications are accepted according to the adjusted categories
If the medical device is approved for registration, the medical device registration certificate shall be issued, and the adjusted product management category shall be indicated in the remarks column of the registration certificate
(3) Before January 1, 2022, the first-class medical device product filing has been handled in accordance with the 2017 version of the "Medical Device Classification Catalog", and the product filing before April 1, 2023 will continue to be valid
For the filers, there is only one year left to continue producing and selling such products, so the filers should re-register as soon as possible to avoid illegal removal of the products next year
Impact on production and operation enterprises From April 1, 2023, such products shall not be produced, imported or sold without obtaining a medical device registration certificate in accordance with the law
Enterprises that have only recorded the production of Class I medical devices before, if they want to continue to engage in production, they need to apply for a "Medical Device Production License", equipped with workshops, facilities and quality management system documents for the production of Class II medical devices, and need to pass the medical device production license.
On-site inspection by supervisory authorities
In the past, companies that sold Class I medical devices only needed to increase their business scope on their business licenses.
Now, if they want to continue selling, they need to apply for a "Class II medical device business record"