Active Device

At present, it is necessary to conduct performance parameter test, electromagnetic compatibility test (YY 0505-2012/IEC 60601-1-2:2004), electrical safety general standard test (GB 9706.1-2007/IEC 60601-1:1988 + A1 + A2, YY 0709-2009/IEC 60601-1-8:2003) and all the applicable standards of included monitoring functions, such as pulse function (YY 0784-2010/ISO 9919:2005), blood pressure function (YY 0667-2008/IEC 60601-2-30:1999), ECG monitoring function (GB 9706.25-2005/IEC 60601-2-27:1994), etc.
From May 1, 2023, China will implement the new version of GB 9706.1 standard equivalent to IEC 60601-1:2012 and the corresponding parallel standard and special standard, at which time the test will be conducted according to the new version of the standard. Currently only the test report of IEC 60601-1: 1988 + A1 + A2 can be used directly to avoid some test items. The corresponding policies for the implementation of the new standard in 2023 have not been clarified yet.

READ MORE >

How to supervise depends on the specific function and purpose of the APP. If the APP can only record and display data without the function of data processing and calculation, and its displayed data is not used for diagnosis or treatment, the APP will be classified as non-medical devices and NMPA will not supervise it.

If the data of APP is used to assist diagnosis and treatment, and does not involve artificial intelligence technology and big data technology based on deep learning, it shall be supervised according to class II medical devices, with classification code of 21-03.

READ MORE >

A ventilator is a pulmonary ventilation device used to automatically increase or provide ventilation to a patient’s lungs. According to the Guidelines for the Classification of Registration Units of Medical Devices, active medical devices with different technical principles should be classified into different registration units.

According to the state of the art, critical-care ventilators, home-care ventilators, ventilators for first aid and transport, high frequency jet ventilators and high frequency oscillation ventilators with different technical principles should be classified as different registration units. Critical-care ventilators with different technical principles, such as electronically controlled pneumatic ventilators and electrically powered ventilators, should be classified as different registration units.

Ventilators with same technical principles but different product design structures (such as ventilators with different gas circuit designs) should be classified as different registration units. Passive consumables (such as breathing tube, tracheal cannula, mask, etc.) used in combination with the ventilator should be classified as different registration units.

READ MORE >

Ordinary ultrasonic cutter head (excluding transducer) only transmits sound energy, not electric energy, which theoretically has no effect on EMC performance. In order to identify the functions of disposable use and collect the working parameters of some ultrasonic cutter heads, there is a chip in the cutter head, which needs power supply and may affect the EMC performance. For the ultrasonic cutter head without chip and without transmitting conductive signal and electric energy, one type of cutter head can be selected for detection.

READ MORE >

Definitely not. Changes in clinical functions shall be major updates of software. If the naming rules for software version number specified by the manufacturer cannot clearly distinguish major and minor software updates, software release version number shall follow its higher risk. The software release version in China shall reflect such changes.

For example, the naming rule of software version number developed by the manufacturer is X.Y.Z, of which X represents major update, Y represents minor update and Z represents correction. If the change of clinical function is reflected in the Y field, the software release version number shall be determined as X.Y.

READ MORE >

Accessories for radiation protection, such as radiation protection clothing, radiation protection cap, radiation protection skirt, radiation protection collar, medical radiation protection glasses, etc., are used for the protection of human body during radiation diagnosis. Such protective accessories usually are connected with active equipment by no power connection or other physical connection. They are managed separately as medical devices in the classification catalogue and are recommended to be declared separately. Except for non-removable accessories.

READ MORE >

The endoscopes mentioned in the clinical trial exemption list are limited to conventional-designed products. Endoscopes like disposable electronic endoscopes (including combined endoscopes that are disposable as a whole and only the insertion part is disposable), three-dimensional endoscopes and capsule endoscopes are not included in the clinical trial exemption list.

READ MORE >