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In order to strengthen the supervision and management of medical sodium hyaluronate (sodium hyaluronate) products, further standardize the registration (filing) of relevant products, and ensure the safety and effectiveness of public pharmaceutical devices, in accordance with the relevant provisions of the Drug Administration Law and the Regulations on the Supervision and Administration of Medical Devices, the following announcement is made on matters related to the management of such products:
1.
According to different intended uses (indications), working principles, etc.
, medical sodium hyaluronate (sodium hyaluronate) products are managed separately according to the following situations:
According to different intended uses (indications), working principles, etc.
, medical sodium hyaluronate (sodium hyaluronate) products are managed separately according to the following situations:
(1) Products used to treat arthritis, dry eye, etc.
, shall be managed
in accordance with drugs.
, shall be managed
in accordance with drugs.
(2) When the following circumstances are met and do not contain pharmaceutical ingredients that exert pharmacological, metabolic or immunological effects, the management category shall not be lower than Class
II according to the management of medical devices.
II according to the management of medical devices.
1.
When applied as a contact lens care product, it is managed
in accordance with Class III medical devices.
When applied as a contact lens care product, it is managed
in accordance with Class III medical devices.
2.
When applied as an absorbable surgical anti-adhesion material, it is managed
in accordance with Class III medical devices.
When applied as an absorbable surgical anti-adhesion material, it is managed
in accordance with Class III medical devices.
3.
When applied as an ophthalmic viscoelastic agent, it is managed
in accordance with Class III medical devices.
When applied as an ophthalmic viscoelastic agent, it is managed
in accordance with Class III medical devices.
4.
When applied as an injection filling product to increase tissue volume, it is managed
in accordance with Class III medical devices.
When applied as an injection filling product to increase tissue volume, it is managed
in accordance with Class III medical devices.
5.
When injected into the dermis layer, it is mainly applied to improve the skin condition through the moisturizing and hydrating effects of sodium hyaluronate contained in it, and it is managed
according to Class III medical devices.
When injected into the dermis layer, it is mainly applied to improve the skin condition through the moisturizing and hydrating effects of sodium hyaluronate contained in it, and it is managed
according to Class III medical devices.
6.
When used to repair the bladder epithelial glucosamine protective layer, it is managed
in accordance with Class III medical devices.
When used to repair the bladder epithelial glucosamine protective layer, it is managed
in accordance with Class III medical devices.
7.
When used as a medical dressing, if the product can be partially or completely absorbed by the human body, or used for chronic wounds, it shall be managed according to Class III medical devices; If the product cannot be absorbed by the human body and is used for non-chronic wounds, it is managed
as a Class II medical device.
When used as a medical dressing, if the product can be partially or completely absorbed by the human body, or used for chronic wounds, it shall be managed according to Class III medical devices; If the product cannot be absorbed by the human body and is used for non-chronic wounds, it is managed
as a Class II medical device.
8.
When applying scar repair dressings to assist in improving pathological scars on the skin and preventing the formation of pathological scars on the skin, they shall be administered
in accordance with Class II medical devices.
When applying scar repair dressings to assist in improving pathological scars on the skin and preventing the formation of pathological scars on the skin, they shall be administered
in accordance with Class II medical devices.
9.
When applied as auxiliary materials for the healing of mouth ulcers and oral tissue wounds, it shall be managed
in accordance with Class II medical devices.
When applied as auxiliary materials for the healing of mouth ulcers and oral tissue wounds, it shall be managed
in accordance with Class II medical devices.
10.
When the lubricant is introduced as a body cavity device (excluding condoms), it shall be managed
according to Class II medical devices.
When the lubricant is introduced as a body cavity device (excluding condoms), it shall be managed
according to Class II medical devices.
11.
Condoms containing sodium hyaluronate lubricant are managed
in accordance with Class II medical devices.
Condoms containing sodium hyaluronate lubricant are managed
in accordance with Class II medical devices.
(3) For pharmaceutical and device combination products containing sodium hyaluronate (sodium hyaluronate), it shall be judged as a drug-device combination product based on the primary action mode of the product or the drug and device combination product
with the main effect of the medical device.
The addition of antibacterial ingredients
to drug-device combination products is not advocated.
with the main effect of the medical device.
The addition of antibacterial ingredients
to drug-device combination products is not advocated.
Medical dressing products containing antibacterial ingredients and injectable fillers for plastic surgery containing drugs shall be judged according to the following principles:
1.
Medical dressing products containing antibacterial ingredients shall provide non-clinical pharmacodynamic studies and/or clinical studies to confirm whether the product has antibacterial therapeutic effects
.
Non-clinical pharmacodynamic studies and/or clinical studies and evaluation criteria used to determine whether a product has antimicrobial therapeutic effects can refer to the non-clinical and clinical technical guidelines
related to drug development.
(1) If non-clinical pharmacodynamic studies and/or clinical studies confirm that the product has a clear antibacterial therapeutic effect, wherein the product that mainly achieves its intended use through antibacterial therapeutic effect is judged to be a drug-based drug-device combination product; Products that mainly achieve their intended use through wound physical coverage and exudation absorption are judged to be medical devices-based pharmaceutical device combination products
.
(2) If non-clinical pharmacodynamic studies and/or clinical studies do not show that the product has antibacterial therapeutic effects, the product is managed
as a medical device.
Medical dressing products containing antibacterial ingredients shall provide non-clinical pharmacodynamic studies and/or clinical studies to confirm whether the product has antibacterial therapeutic effects
.
Non-clinical pharmacodynamic studies and/or clinical studies and evaluation criteria used to determine whether a product has antimicrobial therapeutic effects can refer to the non-clinical and clinical technical guidelines
related to drug development.
(1) If non-clinical pharmacodynamic studies and/or clinical studies confirm that the product has a clear antibacterial therapeutic effect, wherein the product that mainly achieves its intended use through antibacterial therapeutic effect is judged to be a drug-based drug-device combination product; Products that mainly achieve their intended use through wound physical coverage and exudation absorption are judged to be medical devices-based pharmaceutical device combination products
.
(2) If non-clinical pharmacodynamic studies and/or clinical studies do not show that the product has antibacterial therapeutic effects, the product is managed
as a medical device.
2.
Drugs containing local anesthetics (such as lidocaine hydrochloride, amino acids, vitamins), injection fillers for plastic surgery that mainly increase tissue volume by filling, are judged to be medical device-based pharmaceutical device combination products
.
Drugs containing local anesthetics (such as lidocaine hydrochloride, amino acids, vitamins), injection fillers for plastic surgery that mainly increase tissue volume by filling, are judged to be medical device-based pharmaceutical device combination products
.
3.
Medical cosmetology injection materials containing local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins, etc.
), mainly through the moisturizing and hydrating effects of sodium hyaluronate contained in it, improve the skin condition, and are judged to be medical device combination products
.
Medical cosmetology injection materials containing local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins, etc.
), mainly through the moisturizing and hydrating effects of sodium hyaluronate contained in it, improve the skin condition, and are judged to be medical device combination products
.
4.
Body cavity devices containing drugs (excluding condoms) are introduced with lubricant and judged to be medical devices-based pharmaceutical device combination products
.
Body cavity devices containing drugs (excluding condoms) are introduced with lubricant and judged to be medical devices-based pharmaceutical device combination products
.
2.
Products applied to the skin, hair, nails, lips and other human surfaces for the purpose of cleaning, protecting, modifying and beautifying by rubbing, spraying or other similar methods are not managed
in accordance with drugs or medical devices.
Products applied to the skin, hair, nails, lips and other human surfaces for the purpose of cleaning, protecting, modifying and beautifying by rubbing, spraying or other similar methods are not managed
in accordance with drugs or medical devices.
Products used to relieve vaginal dryness (excluding products used for vaginal wound care) are not regulated
as drugs or medical devices.
as drugs or medical devices.
Lotions, disinfectants, disinfectant pads, etc.
containing disinfectant ingredients that are only used for broken skin and wound disinfection are not managed
in accordance with drugs or medical devices.
containing disinfectant ingredients that are only used for broken skin and wound disinfection are not managed
in accordance with drugs or medical devices.
3.
After the modified sodium hyaluronate (sodium hyaluronate) is verified, if the relevant physical, chemical and biological properties are consistent with sodium hyaluronate, the management properties and management categories can be implemented with reference to this announcement
.
After the modified sodium hyaluronate (sodium hyaluronate) is verified, if the relevant physical, chemical and biological properties are consistent with sodium hyaluronate, the management properties and management categories can be implemented with reference to this announcement
.
4.
From the date of issuance of the announcement, the registration application
of medical sodium hyaluronate (sodium hyaluronate) products will be accepted according to the above management categories.
From the date of issuance of the announcement, the registration application
of medical sodium hyaluronate (sodium hyaluronate) products will be accepted according to the above management categories.
5.
For the registration application that has been accepted in accordance with the drug or medical device, the variety that is being reviewed and approved shall continue to be reviewed and approved in accordance with the drug or medical device, and if it meets the requirements, the drug approval number or medical device registration certificate
shall be issued.
Among them, if it is necessary to change the administrative attribute or category, the deadline for limiting the validity period of the approval number or registration certificate is December 31
, 2024.
For the registration application that has been accepted in accordance with the drug or medical device, the variety that is being reviewed and approved shall continue to be reviewed and approved in accordance with the drug or medical device, and if it meets the requirements, the drug approval number or medical device registration certificate
shall be issued.
Among them, if it is necessary to change the administrative attribute or category, the deadline for limiting the validity period of the approval number or registration certificate is December 31
, 2024.
6.
If a product that has obtained a drug approval number or a medical device registration certificate needs to change its management attributes or management category, the original drug approval number or medical device registration certificate shall continue to be valid during the validity period of the certificate; The enterprises involved shall actively carry out the conversion work in accordance with the relevant requirements of the corresponding management attributes and categories, and complete the conversion
before December 31, 2024.
If the original drug approval number or medical device registration certificate expires during the conversion work, provided that the product is safe and effective and no serious adverse events or quality accidents occur after marketing, the enterprise may apply for an extension to the original approval department according to the original management attributes and categories, and if the extension is granted, the validity period of the original drug approval number or medical device registration certificate shall not exceed December 31
, 2024.
If a product that has obtained a drug approval number or a medical device registration certificate needs to change its management attributes or management category, the original drug approval number or medical device registration certificate shall continue to be valid during the validity period of the certificate; The enterprises involved shall actively carry out the conversion work in accordance with the relevant requirements of the corresponding management attributes and categories, and complete the conversion
before December 31, 2024.
If the original drug approval number or medical device registration certificate expires during the conversion work, provided that the product is safe and effective and no serious adverse events or quality accidents occur after marketing, the enterprise may apply for an extension to the original approval department according to the original management attributes and categories, and if the extension is granted, the validity period of the original drug approval number or medical device registration certificate shall not exceed December 31
, 2024.
7.
Cold gels, photon cold gels, liquid dressings, paste dressings and other products that have been filed for Class I medical devices shall be implemented
in accordance with the relevant requirements of the Notice on Matters Related to the Implementation of the Catalogue of Class I Medical Devices (NMPA Circular No.
107 [2021]) and the Announcement on Adjusting Part of the Classification Catalogue of Medical Devices (NMPA Announcement No.
25, 2022).
Cold gels, photon cold gels, liquid dressings, paste dressings and other products that have been filed for Class I medical devices shall be implemented
in accordance with the relevant requirements of the Notice on Matters Related to the Implementation of the Catalogue of Class I Medical Devices (NMPA Circular No.
107 [2021]) and the Announcement on Adjusting Part of the Classification Catalogue of Medical Devices (NMPA Announcement No.
25, 2022).
8.
All relevant enterprises shall earnestly implement the main responsibility for product quality and safety to ensure the safety and effectiveness
of listed products.
Drug regulatory departments at all levels should strengthen publicity and training, and effectively do a good job in relevant product review and approval and post-market supervision
.
All relevant enterprises shall earnestly implement the main responsibility for product quality and safety to ensure the safety and effectiveness
of listed products.
Drug regulatory departments at all levels should strengthen publicity and training, and effectively do a good job in relevant product review and approval and post-market supervision
.
9.
This announcement shall be implemented from the date of promulgation, and the "Announcement on the Management Category of Medical Sodium Hyaluronate Products" (formerly Announcement No.
81 of 2009 of the State Food and Drug Administration) shall be abolished
at the same time.
This announcement shall be implemented from the date of promulgation, and the "Announcement on the Management Category of Medical Sodium Hyaluronate Products" (formerly Announcement No.
81 of 2009 of the State Food and Drug Administration) shall be abolished
at the same time.
State Food and Drug Administration
November 10, 2022
