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- Device Classification: Determine the classification of your medical device according to China's classification rules (Class I, II, or III). This classification will dictate the regulatory requirements and the specific registration pathway.
- Classification of Your Device: Determine the classification of your medical device according to China's classification rules (Class I, II, or III). This classification will determine the applicable regulatory requirements.
- Class I Devices: Typically, Class I devices that do not require the involvement of a Notified Body (self-certification) may have lower certification costs compared to higher-risk classes.
- Complete and Clear Documentation: Technical documentation must be complete, accurate, and clear, providing all necessary information for assessment and approval.
- Classification and Conformity Assessment Decision: Determine the correct classification of the ventilator and select the appropriate conformity assessment procedure (self-certification or involving a Notified Body).
- Correct Classification: Determine the correct classification of the ventilator according to the rules set out in Annex VIII of the MDR. The classification depends on factors such as intended use, duration of use, and invasive nature of the device.
- 2024-07-22Device Description: Detailed description of the ventilator, including its intended use, specifications, and features.
- 2024-07-22Identify whether your ventilator falls under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Ventilators typically fall under the MDR.
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