Q：Can you define in detail about the "non-high-risk" and “expected performance of domestic and racial differences"?
A：
(1) If the second level of new medical devices can be excluded as four exceptional conditions, it can be considered as non-high-risk medical devices originally.
(2) Because of the corneal differences of East and West, there may be concern about racial differences, such us contact lenses. Most of the second level of medical devices compared to people without racial differences.
Note: The exceptional conditions for second level of new medical devices:
1. The differences between products which have been sale on the market and second level of new medical devices cannot prove its safety and effectiveness which were verified by the laboratory methods.
2. The devices have racial differences.
3. Intended use or indications had been requested under the listed product (or intended use, indications were reported domestic and abroad have significant adverse reactions)
4. The product has been on the U.S. and EU markets, indications of its intention applying beyond the scope of the U.S. and the EU who are approved.
Q：Is it acceptable for domestic manufacturers who have the CE mark certification to reduce TFDA plant operating check?
A：We are trying to get the recognition of the EU mutually of the efforts in the future.
Q：While applying for QSD, as the scope listed on ISO 13485 certificate is too large. Whether there are other options available to replace Notified Body Description letter or not?
A：Our GMP / QSD check login is classified items. So when the scope is too large for manufacturers to correspond to the actual class difficultly, it still made by the Notified Body Supplement.
Q：TFDA asked the company to send “electromagnetic compatibility test report”, so what’s the meant by "electromagnetic compatibility"? Why does medical electrical devices category or system need to do electromagnetic compatibility (EMC) test?
A：According to the laws of physics, moving electric field generates a magnetic field, and vice versa. We live in the environment which is filled with a variety of electrical appliances, especially lots of medical devices will be operated in hospital (there must be more medical devices in this kind of environment). It will affect safety and health of patients with the diagnosis of disease, surgery or a purpose of support the patient life, such as influenced by other devices’ electromagnetic effects, or interferes with other devices. Therefore, medical electrical devices must be carried out electromagnetic compatibility (Electromagnetic compatibility, referred to EMC) tests.
Electromagnetic compatibility tests include:
1. To confirm the usage in devices or systems do not occur electromagnetic interference beyond the provision, you need to test according to relevant standards (method) called Electromagnetic Interference (referred to EMI) test.
2. To confirm devices or systems in the surrounding electromagnetic environment still can be operated completely and will not detract from its function, you need to test according to relevant standards (method) called Electromagnetic Susceptibility (referred to EMS) test.
Q：What’s the important point that TFDA review Electromagnetic compatibility (EMC) test report carefully?
A：The key-points that TFDA require for EMC reporting are as follows:
(1) It should contain the relevant information of testing laboratory and testers’ signature (seal), in accordance with the relevant standards (method) name and year (revision), power supply specifications, testing product’s name and description, model, manufacturer's name and address. (The last four published content should be consistent with the application product)
(2) It should refer to the relevant international or regional or national standards (method). For example: Formulated by the International Electrotechnical Commission standard IEC 60601-1-2 (EMI includes: IEC CISPR 11, IEC 61000-3-2, IEC 61000-3 -3, EMS includes: IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000 -4-11). If these items wouldn’t test completely, laboratory or the original manufacturer should explain the reason for non-testing items under the structure of standard (method). When it is necessary, it should refer to the provisions of the standards described. (For example: Vendor attached the data which is not processing to IEC 61000-3-2 project, but this standard applies to the rated voltage ≧ 220V, input current ≦ 16A / per phase and its powered by a generally low-power system device. If vendor’s information attached the specifications are not complete, reviewers cannot conclude whether this requirement should exempt or not. It will be inclusive of this missing information, and will be explained by testing laboratory or the original manufacturer about the product specifications and standards for the provision of instructions).
(3) It shall submit the full report issued by the testing laboratory, rather than the content of excerpts of the report. (The full report should include specifications, methods, and results of the original record book)
(4) If the product for in vitro diagnostic medical devices (IVD), you can refer to IEC 61326-1: 2005 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements) and IEC 61326-2-6: 2005 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment). If manufacturers using the criteria above to illustrate the electromagnetic compatibility of the products (EMC), they must submit a complete report of the test included: product name (including models), test pattern (such as PC-link data transmission function), test time, test sites, reference standards and other information. The electromagnetic compatibility (EMC) standard (IEC 61326-1: 2005, IEC 61326-2-6: 2005) references the contents of electromagnetic interference (EMI) and electromagnetic susceptibility (EMS) standards. The report must contain all references standard test results.
(5) Electromagnetic Interference (EMI) standard reference test:
CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics
IEC 61000-3-2: Harmonic current emissions
IEC 61000-3-3: Voltage changes, voltage fluctuations and flicker in public low-voltage supply systems
(6) Electromagnetic Susceptibility (EMS) standard reference test:
IEC 61000-4-2: Electrostatic discharge immunity test (ESD)
IEC 61000-4-3: Radiated, radio-frequency, electromagnetic field immunity test (RS)
IEC 61000-4-4: Electrical fast transient / burst immunity test
IEC 61000-4-5: Surge immunity test
IEC 61000-4-6: Conducted RF
IEC 61000-4-8: Rated power frequency magnetic field (PMF)
IEC 61000-4-11: Voltage dip, Short interruptions
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