National Key Regulatory Medical Device Catalog (2009 Edition)
I. Single-use Sterile Medical Devices
1. Single-use Sterile Syringes;
2. Single-use Infusion Devices;
3. Single-use Blood Transfusion Devices;
4. Single-use Burette Type Infusion apparatus;
5. Single-use intravenous infusion needle;
6. Single-use sterile hypodermic needle;
7. Single-use plastic blood bag;
8. Single-use blood collector;
9. Single-use anesthesia puncture kit;
10. Medical suture needle (thread).
Second, orthopedic implants medical devices
1. surgical implants joint prosthesis;
2. metal straight, shaped bone plate;
3. metal bone, orthopedic nails;
4. metal orthopedic rods;
5. intramedullary needles, bone pins;
6. spinal fixation equipment.
Three, implantable medical devices
1. artificial crystal;
2. artificial heart valves;
3. cardiac pacemakers;
4. intravascular stents, catheters, guide wires, balloons.
Four, filler materials
1. Breast filler materials;
2. Intraocular filler materials;
3. Orthopedic filler materials.
V. Allogeneic medical devices
1. allogeneic bone;
2. allogeneic skin;
3. biological amniotic membrane.
VI. Animal-derived medical devices
1. Artificial biological heart valves;
2. Bio-protein sponges;
3. Bio-films;
4. Xenogeneic bone repair materials;
5. Bio-dressings;
6. Tissue-engineered whole-layer skin;
7. Bio-adhesives.
VII. Medical devices for family planning
1. Intrauterine device;
2. Rubber condom.
VIII, extracorporeal circulation and blood treatment medical equipment
1. Hollow fiber dialyzer;
2. Hemodialysis device;
3. Dialysis powder, dialysis solution;
4. Plasma separator cups, plasma piping.
Nine, surgical anti-adhesion medical devices
Ten, corneal reshaping lenses
Eleven, infant incubator
Twelve, medical protective masks, medical protective clothing.
Guangdong Province, the key product catalog of medical device supervision (2012 edition)
I. Production
(A) medical electronic instruments and equipment (cardiac diagnostic instruments; non-invasive monitoring instruments);
(B) operating room, emergency room equipment and appliances (infusion aids);
(C) Physiotherapy and rehabilitation equipment (electrotherapy) Instruments, high-voltage potential therapy equipment);
(D) clinical testing and analysis instruments and in vitro diagnostic reagents (home glucose meters and test strips);
(E) the first time to obtain the certificate of registration of the second and third class of medical devices produced within one year of the production of varieties of manufacturers;
(F) the current year was reported by complaints of the production of varieties of enterprises;
(VII) The previous year and the current year's medical device quality bulletin failed varieties;
(viii) the previous year and the current year ordered a deadline for rectification of varieties produced by the enterprise.
Two, the market
(A) circulation regulation.
1. sterile medical devices;
2. orthopedic implants class;
3. implantable medical devices (IOLs, artificial heart valves, cardiac pacemakers, intravascular stents, catheters, guide wires, balloons, IOLs, rigid, plasma corneal contact lenses);
4. filler materials (breast filler materials, intraocular filler materials, orthopedic Filling materials);
5. Allograft medical devices (allograft bone, allograft skin, bio-amniotic membrane);
6. Interventional devices (intravascular catheters, guidewires and sheaths).
(2) advertising regulation.
1. Medical optical apparatus, instruments and endoscopic equipment (artificial crystals, corneal contact lenses (soft, rigid, plastic corneal contact lenses) and nursing fluids);
2. Physiotherapy and rehabilitation equipment (high-voltage potential therapy equipment, physical therapy and rehabilitation equipment, magnetic therapy equipment, compresses);
3. Traditional Chinese medicine devices (therapeutic instruments).
Three, the use of links
(a) extracorporeal circulation and blood processing medical devices (hollow fiber dialyzer, hemodialysis device, dialysis powder, dialysis fluid, plasma separation cup, plasma piping, circulatory piping);
(b) operating room, emergency room, diagnostic room equipment and appliances (infant care equipment);
(c) implantable materials (implantation) equipment, stents);
(d) filler materials (breast filler materials, intraocular filler materials, orthopedic filler materials).