M
Sreenu, thank you for the English translation!
It looks to be a very positive move, both for clarity and streamlining the processes.
Is there any indication of when the "classification catalogue" will be available?
Under the current regulations our devices (anaesthesia machines) require technical and clinical testing within China, however under the new regulation our clinical evaluation report (via the literature route) should suffice based on article 17.
Our technical standards testing (ISO 60601-1, 80601-2-13 etc.) has been performed by Intertek UK who have a sublicence/agreement from UKAS for the ILAC agreement, which is also observed by the CNAS in China.
If I am understanding it corectly, Article 7 of the new regulation should allow this testing to be upheld and valid for use during the registration process with the CFDA.
What is the expectation of the timelines and clauses such as clinical evidence via literature and technical evidence will be upheld?
At this time I do not have any direct contacts to confirm my assumptions with - I don't want to submit documentation and end up waiting 18 months for them to turn around and request a machine for testing to take another 18 months to get tested...
Best Regards,
MP.
It looks to be a very positive move, both for clarity and streamlining the processes.
Is there any indication of when the "classification catalogue" will be available?
Under the current regulations our devices (anaesthesia machines) require technical and clinical testing within China, however under the new regulation our clinical evaluation report (via the literature route) should suffice based on article 17.
Our technical standards testing (ISO 60601-1, 80601-2-13 etc.) has been performed by Intertek UK who have a sublicence/agreement from UKAS for the ILAC agreement, which is also observed by the CNAS in China.
If I am understanding it corectly, Article 7 of the new regulation should allow this testing to be upheld and valid for use during the registration process with the CFDA.
What is the expectation of the timelines and clauses such as clinical evidence via literature and technical evidence will be upheld?
At this time I do not have any direct contacts to confirm my assumptions with - I don't want to submit documentation and end up waiting 18 months for them to turn around and request a machine for testing to take another 18 months to get tested...
Best Regards,
MP.