Protective equipment
Body temperature measuring equipment
Monitoring equipment
Oxygen equipment
Sterilisation equipment
Medical respiratory equipment
Medical imaging equipment
Injection equipment
Infusion equipment
Cardiopulmonary bypass equipment
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AWestern seven countries head of state meeting (G-7) How much does it cost to file a Class II medical device?Find a Good assistant for, 1 minute quick response, industry-specific support, park support medical equipment companies, one-on-one service, for progress at any time to check!Transparent charges, no charges after the signing of the agreement, for the period without any additional costs.One-stop enterprise service.Save money + save heart + save time!
AThe legal time limit for medical device business licence is 30 working days, and the actual processing takes 10-15 working days.Materials and personnel are complete, Good assistant on behalf of 3 days out of the certificate.
A Scope of operation of Class III medical device business licence: Sales of medical equipment Class III: Medical electronic instruments and equipment Medical Optical Apparatus Instruments and endoscopic equipment Medical magnetic resonance equipment Medical X-ray equipment Operating theatres Emergency room Diagnosis and treatment room equipment and apparatus Class II: clinical testing and analysing instruments. Sales of computer software and auxiliary equipment, electronic products, cultural goods, handicrafts (excluding cultural relics), construction materials, machinery and equipment, furniture, instruments and meters; economic and trade consulting.Retail injection and puncture instruments, medical polymer materials and products, clinical test and analysis instruments, in vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilisation equipment and apparatus.
A Medical device licences are valid for 5 years.If the validity period expires and needs to be renewed, you can find a Good assistant for the continuation of the medical device business licence.
AClass II medical device business scope: Class II medical device business scope: Surgical Instruments 6815 Injection and Puncture Instruments 6820 General Diagnostic Instruments 6821 Medical electronic instruments and equipment 6822 Medical optical instruments and endoscopic equipment 6823 Ultrasonic instruments and related equipment for medical use 6824 Medical laser instruments and equipment 6825 Medical high frequency instruments and equipment 6826 Physiotherapy equipment 6827 Traditional Chinese Medicine Instruments 6828Magnetic resonance equipment for medical use 6830Medical X-ray equipment 6831Medical X-ray accessory equipment and parts 6833 Medical nuclide equipment 6834 Medical radiation protection supplies and devices 6840 clinical testing and analysis instruments (in vitro diagnostic reagents limited to early and early pregnancy test paper, ovulation test paper, urine sugar test paper, blood glucose test paper) 6841 Medical laboratory and basic equipment 6845 Extracorporeal circulation and blood processing equipment 6846 Implantable materials and artificial organs 6854 Operating theatres, emergency rooms, diagnostic and treatment room equipment and apparatus 6855 Dental equipment and apparatus 6856 Ward care equipment and apparatus 6857 Disinfection and Sterilisation Equipment and Apparatus 6858 Medical cold therapy, cryogenic, refrigeration equipment and apparatus 6863 Stomatological materials 6864 Medical hygiene materials and dressings 6865 Medical suture materials and adhesives 6866 Medical polymer materials and products 6870 Software preparation
AMedical device business licence should be in the location of the municipal food and drug related departments to apply for Application needs to have the relevant conditions: with the business scope and scale of operation of the quality management institutions or quality management personnel, quality management personnel should have relevant professional qualifications or titles. Medical device license required materials: a copy of the business licence; legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, a copy of the academic qualifications or professional titles.
1Business Licence.
2Application Report.
3Supporting documents for the business premises and warehouse premises, including a copy of the property certificate or lease agreement and the lessor's property certificate.
4Business premises, warehouse layout plan.
5A copy of the identity card, proof of academic qualifications or proof of professional title of the person in charge of the proposed approach, the person in charge of the enterprise, the quality manager, and a copy of his or her curriculum vitae.
1、Submit the information of medical equipment business licence application to the relevant departments
2. Formal review of information
3. Formal acceptance of information
4. Administrative review of relevant departments
7. Certificate making and issuance
6. Administrative decisions of relevant authorities
5. On-site review
Focus on the whole industry, in-depth analysis of the industry real-time attention to industry dynamics
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