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14 mandatory standards will be put into force from 2017.01.01

from CIRS by
There are 14 mandatory standards will be implemented from 2017. If your product involves those standards, you shall obey the following rules.
1. If your product in the stage of registration documents preparation, you shall ensure that the performance indexes meet the requirements of new standards. If your product does not meet the requirements, you shall correct the product.
2. If your product has obtained the registration certificate, you shall manufacture your product according to the new standard from 2017.01.01. Otherwise your product will be determined to be non-conforming product in testing by CFDA.
3.If you want to renew your certificate, you shall provide the new registration inspection report which meet the new standard.

Mandatory Standard list:

No.Standard No.Standard NameIssued time
1YY 0952-2015Medical Temperature Blankets2015/3/2
2YY 0572-2015Water for haemodialysis and related therapies2015/3/2
3YY 0953-2015Medical Carboxymethyl Chitosan2015/3/2
4YY 0951-2015Interference electricity therapeutic device2015/3/2
5YY 0950-2015Extracorporeal pressure wave therapy devices by compressed air2015/3/2
6YY 0948-2015Cardiopulmonary bypass systems-Arteriovenous cannula for single use.2015/3/2
7YY 0945.2-2015Medical electrical equipment - Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source2015/3/2
8YY 0832.2-2015Stereotactic and planning system with X-radiation - Part 2:Stereotactic and planning system for radiotherapy with X-radiation for body lesion2015/3/2
9YY 0831.2-2015Stereotactic radiotherapy system with gamma beam - Part 2:Multi-Source stereotactic radiotherapy system with gamma beam for body lesion2015/3/2
10YY 0605.9-2015Implants for surgery-Metallic materials-Part 9:Wrought high nitrogen stainless steel2015/3/2
11YY 0603-2015Cardiovascular implants and artificial organs--Hard-shell cardiotomy/venous reservoir bags2015/3/2
12YY 0599-2015Therapeutic laser equipment - Excimer laser cornea ametropia cure system2015/3/2
13YY 0598-2015Concentrates for haemodialysis and related therapies2015/3/2
14YY 0954-2015Nonactive surgical implants--Type I collagen implants--Specific requirements2015/3/2

If you need the new standards in English, please contact us.
Windy
windy@cirs-group.com.


  

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