1.What’s the registration unit rule under Chinese regulation for ventilators?
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.
2.How to conduct clinical trials of ventilator integrated cardiopulmonary impedance monitoring module?
This module is not recommended for registration with the ventilator.
In clinical practice, the cardiopulmonary impedance indicator can be used as a reference to adjust the parameters of the ventilator. When the data reaches the adjustment indicator, the physician judges whether it is necessary to make adjustment and records the subsequent patient-related data, so as to evaluate whether the parameter indicator have positive adjustment, negative adjustment or no impact on the main effectiveness evaluation indicators.
3.How to conduct laboratory comparison for predicates without authorization, and whether the reviewers approve the laboratory comparison data?
Laboratory comparison data for unauthorized predicates can be included as part of the CER. The success of CER pathway also depends on the adequacy of other data, such as previous clinical research data, literature data, etc.
4.How does NMPA supervise the sleep respiratory monitoring APP installed on the patient’s mobile phone?
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.
5.The blood oxygen module used in combination with ventilators shall be clinically evaluated through laboratory human study. If the product is not marketed in China, whether the racial difference (difference in skin color evaluation) shall be considered in this evaluation?
The ethnic differences should be considered and the data of Chinese or Asian Americans should be included.
Recommendations based on clinical evaluation of blood oxygen: The manufacturer is advised to consider the age of patients. Different ages should be included as widely as possible, covering at least 18 to 45 years old. The problem of skin melanin precipitation should be considered in this clinical study. Subjects with different degrees of melanin precipitation (or dark skin) should be included, involving at least two subjects with melanin precipitation or at least 15% of subjects with melanin precipitation (whichever is larger).
6.What certification tests are required for the monitor products? Whether test results already available in country of origin can be used？
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.
