FAQ

To increase the sterilization method by changing the registration of permission items, it is necessary to submit sterilization verification data and carry out sterility performance test.

In case of any other performance changes caused by the addition of sterilization methods, the test shall be conducted. For example, if the sterilization method of ethylene oxide is added, the sterility test item and residual amount of ethylene oxide shall be added.

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It is necessary to clarify method and parameters of heat treatment of the product, evaluating and verifying the suitability of the heat treatment method. The basis for determining the heat treatment parameters (including heating time, holding temperature, holding time, etc.) and the acceptability criteria of the results after heat treatment also need to be clarified.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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According to Guidelines for Technical Review of Animal-based Medical Device Registration (2017 Revision), to apply for the registration of animal derived medical devices, the description of the process of inactivating and removing viruses and / or infectious factors in the production process and the effectiveness verification data or relevant materials shall be provided.

The efficacy of virus inactivation can be validated through laboratory validation or from suppliers of animal-derived materials, or evaluated through literature or historical data. If the validation data submitted are not based on the data obtained from the validation of the declared product itself, an analysis and demonstration of its applicability shall be conducted

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The biological evaluation can’t be exempted. The equivalence comparison can be used to prove that the product under application has the same biocompatibility with the marketed product, so as to determine the reduction or exemption of biological test for the product under application.

For materials conforming to Appendix B of YY 0341.1, equivalence comparison is still required, such as demonstrating whether new biological risks are introduced in the production process and whether the production processes (processing process, sterilization process, packaging, etc.) are the same.

Since the production process may also introduce new harmful substances (residues such as sterilizers, processing AIDS and demoulding agents), if it is evaluated that the production process does not introduce new biological risks, it can be considered to be exempted from biological tests.

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