The " Medical Device Classification Rules" has been implemented since January 1, 2016. The State Food and Drug Administration is also in the process of carrying out the revision of the "Medical Devices Classification Catalogue". It is expected that the new edition of the "Catalogue" will be introduced this year.

China's medical devices were disclosed in early March. The new edition of the Catalogue has adjusted the original 43 subdirectories of the 2002 edition to 22 subdirectories, and CFDA has initially completed the revision of the first 11 subdirectories.

However, the latest news is that the preparation of the first 22 sub-directories and the registration of information related information have been initially completed in late March.

The CFDA Medical Device Standardization Center held an expert seminar on commonality and special issues in the catalogue revision work in Beijing on March 21, and a preliminary summary of the revised catalogue was carried out. Zhang Zhijun, deputy director of the Standardization Center, requested that the draft for review be completed as scheduled at the end of June.

On March 29-30, the CFDA Medical Device Standardization Center held a seminar on “Clinical Laboratory Medical Device Classification (Revised)” in Beijing. The news will be uploaded. According to the schedule, the clinical examination medical device classification catalogue (revised draft) will enter the public notice period in mid-April.

According to Chinese medical devices, the clinical laboratory medical device classification catalog is one of the 11 sub-directories that were first revised. The catalogue is under the responsibility of the Beijing Medical Device Quality Supervision and Inspection Center.

The new 22 clinical test instrument subdirectory will be merged from the 6840 and 6841 subdirectories in the 2002 version of the catalog.

43 subdirectories of the old version of the Medical Device Classification

"Medical Devices Classification Catalogue" 2002 Edition

6801 basic surgical instruments

6802 microsurgical instruments

6803 neurosurgery instrument

6804 ophthalmic surgical instruments

6805 ENT surgical instruments

6806 Stomatological Surgical Instruments

6807 Thoracic Cardiovascular Surgical Instruments

6808 abdominal surgery equipment

6809 urinary anorectal surgery equipment

6810 Orthopaedic (Orthopedic) Surgical Instruments

6812 surgical instruments for obstetrics and gynecology

6813 family planning surgical instruments

6815 injection puncture device

6816 burn ( orthopedics) surgical instruments

6820 general examination equipment

6821 Medical electronic equipment

6822 Medical optical instruments, instruments and endoscope equipment

6823 medical ultrasound equipment and related equipment

6824 medical laser equipment

6825 medical high frequency equipment

6826 physical therapy and rehabilitation equipment

6827 Chinese medicine equipment

6828 medical magnetic resonance equipment

6830 medical X-ray equipment

6831 medical X-ray accessory equipment and components

6832 medical high energy ray equipment

6833 medical nuclides equipment

6834 medical radiation protection products and devices

6840 clinical test analysis instrument

6841 medical laboratory and basic equipment

6845 extracorporeal circulation and blood processing equipment

6846 implant materials and artificial organs

6854 operating room, emergency room, medical equipment and equipment

6855 Dental Equipment and Apparatus

6856 ward care equipment and appliances

6857 Disinfection and Sterilization Equipment and Apparatus

6858 medical cold therapy, low temperature, refrigeration equipment and appliances

6863 dental materials

6864 medical hygienic materials and dressings

6865 medical suture material and adhesive

6866 medical polymer materials and products

6870 software

6877 intervention equipment

As shown in the above table, the old version 6840 corresponds to a clinical test analysis instrument, and the 6841 corresponds to a medical test and a basic equipment.

Pain Relief Patch(Pain Areas)

Pain Relief Patch
[Name] Medical Cold Patch
[Package Dimension] 6cm×8cm 4pieces/box
The pain relief patch is composed of three layers, namely, backing lining, middle gel and protective film. It is free from pharmacological, immunological or metabolic ingredients.
[Scope of Application]
For cold physiotherapy, closed soft tissue only.
[Indications]
The patches give fast acting pain relief for strains, sprains, cramp, bruises, swollen areas or joint stiffness.
[How To Use a Patch]
Please follow the Schematic Diagram. One piece, one time.
The curing effect of each piece can last for 6-8 hours.
[Attention]
Do not apply the patch on the problematic skin, such as wounds, eczema, dermatitis,or in the eyes. People allergic to herbs and the pregnant are advised not to use the medication. If swelling or irritation occurs, please stop using and if any of these effects persist or worsen.notify your doctor or pharmacist promptly. Children using the patch must be supervised by adults.
[Storage Conditions]
Store below 30c in a dry place away from heat and direct sunlight.

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