14 mandatory standards will be put into force from 2017.01.01

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 Name	Issued time
1	YY 0952-2015	Medical Temperature Blankets	2015/3/2
2	YY 0572-2015	Water for haemodialysis and related therapies	2015/3/2
3	YY 0953-2015	Medical Carboxymethyl Chitosan	2015/3/2
4	YY 0951-2015	Interference electricity therapeutic device	2015/3/2
5	YY 0950-2015	Extracorporeal pressure wave therapy devices by compressed air	2015/3/2
6	YY 0948-2015	Cardiopulmonary bypass systems-Arteriovenous cannula for single use.	2015/3/2
7	YY 0945.2-2015	Medical electrical equipment - Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source	2015/3/2
8	YY 0832.2-2015	Stereotactic and planning system with X-radiation - Part 2:Stereotactic and planning system for radiotherapy with X-radiation for body lesion	2015/3/2
9	YY 0831.2-2015	Stereotactic radiotherapy system with gamma beam - Part 2:Multi-Source stereotactic radiotherapy system with gamma beam for body lesion	2015/3/2
10	YY 0605.9-2015	Implants for surgery-Metallic materials-Part 9:Wrought high nitrogen stainless steel	2015/3/2
11	YY 0603-2015	Cardiovascular implants and artificial organs--Hard-shell cardiotomy/venous reservoir bags	2015/3/2
12	YY 0599-2015	Therapeutic laser equipment - Excimer laser cornea ametropia cure system	2015/3/2
13	YY 0598-2015	Concentrates for haemodialysis and related therapies	2015/3/2
14	YY 0954-2015	Nonactive surgical implants--Type I collagen implants--Specific requirements	2015/3/2

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

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