Some home care products will no longer be regulated as medical devices, which will unleash huge market vitality

Some home care products will no longer be regulated as medical devices, which will unleash huge market vitality.
China has released a list of 301 products that will no longer be managed as medical devices in 2022, mainly involving health and rehabilitation products and medical software products that are widely used in daily life. This kind of product is gradually entering the home application scene, without the help and guidance of doctors and nurses, you can use alone to relieve physical discomfort, without great harm to medicine. No longer subject to strict medical management, it will promote more manufacturers to lower prices, improve quality, stimulate market vitality, and help more Chinese daily health care products to enter the international market. Healthsmile Medical Technology Co., Ltd. will continue to provide customers with high-quality and affordable health care products. Such products are as follows:

-Waterproof adhesive: polyurethane film, external quadrilateral border coated with medical pressure sensitive adhesive, the middle quadrilateral without glue. It is used to apply to the skin around the wound application that has been applied to the wound or medical instruments in specific parts of the human body to prevent the wound application or medical instruments from being soaked by liquid.
- Anti-bedsore mattress: It is composed of high-density foam pad, polyurethane viscoelastic foam material and polyurethane PU mattress cover. Static mattress that requires no electricity and is not inflated. By using the high elastic material and structural process characteristics of the cushion core, the shape will be changed under the influence of body temperature, and the shape will be softened to fully conform to the outline of the body. The supporting area will be greatly expanded, so as to increase the contact area between patients and the mattress, reduce the local pressure of the body, and finally achieve the purpose of preventing bedsores.
- Medical pillowcase: made of nonwoven fabric and plastic film combined or sewn. For single use non-sterile products. Health care products for hospital beds or examination beds.
- Medical quilt cover: made of nonwoven fabric and plastic film composite or sewn. For single use non-sterile products. Health care products for hospital beds or examination beds.
- Urinary sheath: a collection container in the form of a sheath. It is made of silica gel material. For single use non-sterile products. To use it, the condom is attached to the penis and the urine flows out through the joint under its own gravity. Used to collect urine from patients who cannot voluntarily control their urine. The urethra is not inserted, and the catheter or drainage tube inserted into the body cavity is not connected.
- External urinalysis device: plastic urinalysis bag, catheter, catheterization bag/atrophic catheter bag, fixation belt. It is a reusable non-sterile product. When used, it is placed outside the body on the perineum (for men, on the penis) at the urethral opening. Used to extract and collect urine. The urethra is not inserted, and the catheter or drainage tube inserted into the body cavity is not connected.
- Nursing machine: It is mainly composed of nursing host, toilet (built-in sprinkler) and hand controller. The nursing host includes heating module, power module, main control module, display module, negative pressure pump, water pump, water distribution valve, sewage bucket and clean bucket. Active product. It is expected to be used for cleaning up after the toilet for people with mobility difficulties. This product does not have the function of treating or assisting diagnosis of any disease.
- Mobile bedside bath machine: by suction device, water spraying device, dry skin machine, gardening joint, basin, waste water box (two drainage pipes), disposable waterproof non-woven sheets, host (built-in clean bucket). When in use, start the sprinkler and move the machine to the bedside; The disposable waterproof non-woven sheet is spread on the bed, and the sewage suction head is placed on the disposable waterproof non-woven cloth bed cover, which can automatically suck the sewage back to the sewage tank; After the completion of the bath can be used to dry the patient’s body water stains. For long-term bedridden, partial paraplegic people and the elderly bathe.
- Seat: consists of shell, hydraulic lifting system and wheelchair system. When the product is in use, the original car seat needs to be rebuilt before installation. Mainly used for the elderly and pregnant women to get on and off the bus. Not used in medical institutions for patient transport, nor installed in ambulances for use.
- Displacement vehicle for domestic use: it is composed of bracket, casters, base legs, lifting mechanism assembly and handrails. This product is mainly used for the elderly, patients and disabled people in hospitals, pension institutions and families. By using this product to assist special people to go to bed, bath, toilet.
- Bath chair: It is composed of backboard, armrest, support and foot tube. Passive products. Used as a seat in the shower for people with mobility disabilities.
- Bed for bedridden personnel: It is composed of sanitary ware, sewage collection bucket and posture adjustment system. It is used to clean up the people who cannot move in bed for a long time. The product is not intended for use in medical institutions. It does not have the function of treating or assisting in diagnosis and treatment of any disease.
- Bedside frame: It is composed of handrail tube, support tube, foot tube and fixer. Installed on the home bed, convenient for users to complete the movement of getting up, turning over and so on.
- Handling belt: by the motherboard (fixed seat), webbing, handle, outsourcing, rotating shaft, butterfly screw composition. When in use, the main board (fixing seat) of the product is fixed on the upper backboard of the home bed. It is used to assist elderly people with mobility difficulties to move in bed.
- Toilet chair: It is composed of back tube, seat frame tube, armrest tube, seat cover, seat plate, toilet bucket and foot tube. Passive products. The toilet bucket is stuck to the seat rack, so that people with mobility disabilities can sit on the product and go to the toilet.
- Electric toilet cleaning bed: It is composed of bed body, bed plate, cleaning and blowing parts, driving parts and electrical control parts. It is used to clean up the disabled people who cannot take care of themselves. The product is not used in medical institutions, and does not have the function of treating or assisting the diagnosis and treatment of any disease.


Post time: Jan-08-2023