NMPA Medical Device Classification Results In 2024

On April 9, 2024, the National Medical Products Administration’s Medical Device Standard Management Center issued the “Summary of the First Medical Device Classification Results for 2024.” It has been reported that this summary includes a total of 223 medical device product classifications, with 13 related to the field of medical aesthetics. Among these, there are 4 products recommended to be managed as Class III medical devices, 5 products recommended to be managed as Class II medical devices, 1 product recommended not to be managed as a medical device, 2 products recommended to be defined through the procedure for determining the management attributes of drug-device combination products, and 1 product recommended to be determined based on specific circumstances.

I. Four Products Recommended to be Managed as Class III Devices:

1. Recombinant Type III Human Collagen Freeze-Dried Fibers: A disposable sterile product made from recombinant Type III human collagen and injection-grade water, formed into a sponge-like material.

2. Wigs and Hair Transplant Systems: Consists of a card box, needles, ejectors, anchors, and threads.

3. High Molecular Weight Dressings: Comprised of a semi-permeable polyurethane backing film, perforated silicone gel film (facing towards the wound), and an absorbent pad (composed of cellulose and polyacrylic ester) between the two layers.

4. Medical Biohydrogel: Composed of sodium carboxymethylcellulose, glycerin, bismuth subgallate, gelatin, and purified water.

II. Five Products Recommended to be Managed as Class II Devices:

1. Warm Therapy Device: Consists of a housing, heating application section, heating device, temperature protection device, control device, and therapy device.

2. Red, Blue, Yellow Light Therapy Device: Composed of a main unit, lamp head, arm, data cable, power cord, and eye mask. It utilizes LED light sources in red, blue, yellow, and infrared wavelengths to interact with human tissues through photobiological and biostimulative effects, aiding in the treatment of diseases.

3. Bio-Glass Wound Paste Dressing: Composed of bio-glass, medical sodium hyaluronate, and medical petrolatum, with the bio-glass consisting of SiO2, Na2O, CaO, and P2O5.

4. Photosensitive Hydrogel Dressing Light Curing Machine: Comprising a light source, light source control device, display, and power part, excluding the photosensitive hydrogel dressing.

5. Follicular Transplantation Pneumatic Surgical Chair: Comprised of a seat, U-shaped face pillow, and U-shaped pillow cover.

III. One Product Recommended Not to be Managed as a Medical Device:

1. Skin Peeling and Neutralizing Solution: Composed of peeling solution and neutralizing solution. The peeling solution consists of glycolic acid (α-hydroxy acid), glycerin, and water, with concentrations of 20%, 35%, 50%, and 70% based on glycolic acid content. The neutralizing solution consists of sodium bicarbonate, glycerin, and water. Claimed to dissolve and promote the rapid exfoliation of the skin’s surface layer, separating accumulated keratin and deep-seated secretions in the sebaceous gland openings and follicles.

IV. Two Products Recommended to be Defined as Drug-Device Combination Products:

1. Medical Copper-Based Dressing: Composed of medical degreased cotton thread and copper-iron-zinc alloy microfilaments (with mass percentages of Cu/87.00wt%, Fe/8.00wt%, Zn/5.00wt%).

2. Sterile Ointment Wound Dressing: Composed of petrolatum, sodium carboxymethylcellulose, zinc oxide, and polydimethylsiloxane.

V. One Product Recommended to be Determined Based on Specific Circumstances:

1. Recombinant Abalone Viscous Protein Paste Dressing: Composed of recombinant abalone viscous protein, white petrolatum, isopropyl palmitate, liquid paraffin, cetyl alcohol, sorbitan monostearate, glycerol monostearate, glycerin, dimethicone, hydroxyethyl cellulose, citric acid, hydroxyacetophenone, and purified water, packaged in plastic tubes or bottles. If used for superficial wound care, directly contacting the wound to promote wound healing, it is recommended to be managed as a Class II medical device. If used to prevent excessive transdermal water loss, providing hydration, increasing water content in the stratum corneum and epidermis, softening keratin, and alleviating symptoms of desquamation and dry skin discomfort, it is recommended not to be managed as a medical device.

For further information or if you have any inquiries regarding the newly classified medical devices, please do not hesitate to contact info@bradyknowsmedical.com. Our team at BradyKnows Medical is ready to assist with any needs you may have in understanding these classifications and their implications.