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Test Objects
  • In applying for registration or filing, inspection shall be carried out in accordance with the product technical requirements and the inspection report shall be submitted.
  • Inspection report of medical device submitted for registration or filing can be the self-inspection report of the applicant and the filer, or the inspection report issued by the authorized qualified medical device inspection institution.
Preparation Before Inspection
  • Representative samples that are in line with the national medical device quality management requirements of the production
  • Product technical requirements
  • Product related technical data
  • Have the ability to inspect the items stipulated in the product technical requirements (self-inspection)
Choice of Inspection Institution If the registration applicant submits the self-inspection report and does not have the inspection ability of some items in the product technical requirements, it can entrust the relevant items to a qualified medical device inspection institution for inspection. A qualified medical device testing institution shall comply with the relevant provisions of Article 75 of “the Regulations on the Supervision and Administration of Medical Devices”.
Commissioned Inspection Workflow
  • The applicant shall sign the inspection contract with the inspection center;
  • The applicant shall submit product technical requirements and product technical data, and deliver the samples to the inspection center;
  • Inspection center will carry out testing;
  • The inspection center will issue an inspection report.
Tips The self-inspection report submitted when applying for product registration shall be the inspection report of the whole project in conformity with the technical requirements of the product.

Q&A About Test

  • Q1: What should I do if there are more than one type of product applying for registration?

A1: Products tested in the same registration unit shall be representative of the safety and effectiveness of other products in the same registration unit.

  • Q2: Can the inspected sample be commissioned for production?

A2: The registered applicant for commissioned production may entrust the commissioned production enterprise to carry out self-inspection, and the registered applicant shall issue the corresponding self-inspection report. The self-test capability of the entrusted manufacturer shall meet the relevant requirements of the “Regulations on the Administration of Medical Device Registration Self-Test”.

  • Q3: What should enterprises pay attention to when submitting transformers for inspection?

A3: The enterprise needs to provide complete transformers with twice the number of secondary units, plus 1 unpainted (or disassembled) transformer. And provide the specific specifications of the transformer (insulation level, each secondary test voltage, current, thermal circuit breaker limits, structural diagram), stamp the official seal of enterprises, and provide instructions consistent with the product used.

  • Q4: When independent software is tested according to GB/T 25000.51-2016, do the product description and user documentation collections need to be provided separately? What is the difference between the two?

A4: The software manual needs to provide two types: product description and user documentation collections: the content of the product description needs to meet the software technical requirements 2.2.1. This product description is mainly for potential users. The content of the user documentation collections needs to meet the software technical requirements 2.2.2. The description of this documentation collections is mainly for the use of buyer users. It needs to describe detailed operation steps (including pictures and text descriptions), which can include instruction manuals, quick start manuals, etc., but one of them must include all requirements of technical requirements 2.2.2.

  • Q5: If a product has an internal power supply and a charger. Can the charger not be included? If the charger can not be included, how should this product be classified?

A5: The charger does not need to be a component. If the charger is not a component, it should be added content that complies with the requirements of 6.8.2) h) of GB9706.1-2007 in instructions. When the product charger is not an integral part of the product, if it does not work properly when charging, the product is an internal power supply device; if it can work when charging, the product is a Class II internal power supply device.

  • Q6: What is the content of network security testing for hardware?

A6: Network security content consists of two parts, namely data interface and user access control. The data interface consists of four parts, namely data interface name, transmission protocol, interface purpose, and storage format (media transmission).

  • Q7: The electrodes of the medium frequency therapy device have a heating function. There is a temperature probe inside the electrode piece. When the temperature exceeds the set value, the heating will automatically stop. Does this meet the safety requirements?

A7: These alone cannot meet the requirements. According to the requirements of 56.6 a) in GB 9706.1-2007, when the failure of the thermostat will cause a safety hazard, an independent non-automatic reset thermal circuit breaker should be equipped. The operating temperature of this additional device should be higher than the temperature reached by the normal control device at its maximum setting, but should not exceed the safe temperature limits required for the intended function. For example, if the thermostat fails and the temperature of the applied part exceeds 60°C, which may pose a safety hazard to the patient, it should be equipped with a non-automatic reset thermal circuit breaker, and it must be an independent thermal circuit breaker. Only a thermostat alone isn’t enough.

  • Q8: What kind of products should comply with the GB9706.1 standard for electrical safety, and which products should comply with the GB4793.1 standard?

A8: Medical electrical equipment or systems that comply with the definitions of 3.63 and 3.64 in the GB9706.1-2020 standard need to implement the GB9706.1 standard. Such equipment usually has the function of diagnosis, treatment or monitoring of patients, and has components that need to come into contact with the patient to transmit energy to or obtain energy from patients. This type of equipment conforms to the scope of application of GB4793.1 for laboratory electrical equipment, such as in vitro diagnostic equipment, sterilizers, centrifuges, etc., which comply with the GB4793.1 standard.

  • Q9: Can two identical samples be sent for safety and electromagnetic compatibility testing respectively?

A9: No, the consistency between two products cannot be guaranteed, so the same sample must be used for testing.

  • Q10: Do the optional accessories of the product need to be tested together during registration inspection?

A10: Registered inspection companies need to select representative products in the same registration unit for testing, usually the models with the most complete configurations and functions. Regardless of whether the components are optional accessories, all possible components of the product applying for registration need to be submitted for testing together.