(1) thermometers, sphygmomanometers (various types), electronic blood pressure pulsometer, ambulatory blood pressure monitor
(2) acoustic, optical, electrical, magnetic stimulators, acupuncture needles
(3) magnetic therapy machine, magnetic induction electrotherapy machine, low-frequency electromagnetic integrated therapy machine, specific electromagnetic wave therapy machine, magnetic therapy apparatus
(4 )Hemostatic sponge condoms, contraceptive caps sterile medical gloves
(5)Medical vaginal scrubber, medical vaginal douche
(6)Vacuum blood collection tubes, blood collection needles, laser blood collection machine
(7)Medical suture needles (without thread), automatic urine analyzers and test strips, disposable use of urinary catheters non-absorbable suture (with/without needle)
(8) Hearing aids, infusion pumps, syringe pumps
(9) Electrocardiographic diagnostic instruments, electroencephalographic diagnostic instruments, electromyographic diagnostic instruments, other bioelectrical diagnostic instruments
(10) Diagnostic fiberoptic endoscopes (upper gastrointestinal endoscopes, colonoscopes, colonscopes, bronchoscopes), rigid-tube endoscopes for observation (laryngoscopes, rhinoscopes, cystoscopes, uteroscopes, proctoscopes, amniotic fluid scopes)
< p>(11)Multifunctional ultrasound monitor, ultrasound mother/fetal integrated monitor, ultrasound obstetric monitor, fetal monitor(12)Patient monitor (monitoring parameters including electrocardiography, oxygen saturation, non-invasive blood pressure, pulse, temperature, respiration, end-expiratory carbon dioxide) anesthesia gas monitors, respiratory function monitors, sleep evaluation system, labor and delivery monitors
( 13) abortion suction, negative pressure suction device
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article 16 The application for registration of Class II medical device products, the applicant for registration shall be to the seat of the provincial, autonomous regions, municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to submit the application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application to the State Council Drug Administration.
To China's exports of Class II, Class III medical devices outside the applicant for registration, by its designated enterprise legal person in China to the State Council Drug Administration to submit the application for registration and registration of the applicant's country (region) competent authorities to permit the marketing of the medical device supporting documents. Not in the overseas market of innovative medical devices, can not submit the registration applicant's country (region) competent authorities to authorize the marketing of the medical device documents.
The State Council Drug Administration shall review the medical device registration procedures and requirements, and strengthen the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department of the supervision and guidance of the registration review work.