CFDA MD regulation_20140331 - Comes into effect June 01, 2014

June 01, 2014 , come into effect.

some changes listed:

1) class I listing is OK(previous need device license);
2) changed from "manufacturing license before device license" to "device license before manufacturing license" ;
3) define the content of technical file for "device license" (similar to STED or MDD technical file)
4) clinical literature route is acceptable for class I products, but clinical trial is required for Class II/III products;
5) valid period of device license changed from 4 years to 5 years.
6) more requirement for QMS (similar to ISO 13485).
7) specific requirement for IFU.
8) specific chapter for recall / advisory notice.
9) more strict punitive measure

Re: CFDA MD regulation_20140331

4) Clinical literature route is acceptable for class I products, but clinical trial is required for Class II/III products;

What if the Product do not need the Clinical trial for example Medical Device software.

6) more requirement for QMS (similar to ISO 13485).

Is there a separate standard

7) specific requirement for IFU.

is that a separate standard or is incoporated in the similar standrad as ISO 13485?

cnpacs said:

June 01, 2014 , come into effect.

some changes listed:

1) class I listing is OK(previous need device license);
2) changed from "manufacturing license before device license" to "device license before manufacturing license" ;
3) define the content of technical file for "device license" (similar to STED or MDD technical file)
4) clinical literature route is acceptable for class I products, but clinical trial is required for Class II/III products;
5) valid period of device license changed from 4 years to 5 years.
6) more requirement for QMS (similar to ISO 13485).
7) specific requirement for IFU.
8) specific chapter for recall / advisory notice.
9) more strict punitive measure

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Thanks cnpacs. Do you have the reference document or a weblink ?

Here is the link. http://www.sfda.gov.cn/WS01/CL0784/97814.html

Yesterday CFDA published several regulations for public comments.

Revised Regulations for the Supervision and Administration of Medical Device Manufacturing. Deadline 4/10/2014. Fax 86-10-88363234. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97820.html

Registration (Record Filing) of Medical Devices (draft). Registration (Record Filing) of IVDs (draft). IFUs, Labels, and Package Labels (draft). List of Class II Medical Devices Exempt from Clinical Trials (draft). List of Class III Medical Devices Exempt from Clinical Trials (draft). Deadline 4/30/2014. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97818.html

Regulations for the Supervision and Administration of Medical Device Distribution (draft). Deadline 4/10/2014. Fax: 86-10-88331441. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97817.html

Dear All

Thank-you for sharing these links. I'm wondering if anyone can assist with a couple of questions.

1. Does anyone know how the CFDA will treat applications that are made prior to 1-June-2014 but have not completed the evaluation process, ie will these applications be required to comply with the new regulations or the old ones?

2.

Registration (Record Filing) of Medical Devices (draft). Registration (Record Filing) of IVDs (draft). IFUs, Labels, and Package Labels (draft). List of Class II Medical Devices Exempt from Clinical Trials (draft). List of Class III Medical Devices Exempt from Clinical Trials (draft). Deadline 4/30/2014. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97818.html

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– Does this mean that literature reviews alone are not acceptable for clinical evidence unless the product is listed as ‘exempt’?
- Do products have to meet the specific description ‘product description’ per Appendix 4 & 5 to be exempt ?
- For products not exempt, do the clinical trials have to be conducted in China or can be be conducted anywhere as long as they are to ICH GCP?

thanks

treesei said:

Here is the link. http://www.sfda.gov.cn/WS01/CL0784/97814.html

Yesterday CFDA published several regulations for public comments.

Revised Regulations for the Supervision and Administration of Medical Device Manufacturing. Deadline 4/10/2014. Fax 86-10-88363234. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97820.html

Registration (Record Filing) of Medical Devices (draft). Registration (Record Filing) of IVDs (draft). IFUs, Labels, and Package Labels (draft). List of Class II Medical Devices Exempt from Clinical Trials (draft). List of Class III Medical Devices Exempt from Clinical Trials (draft). Deadline 4/30/2014. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97818.html

Regulations for the Supervision and Administration of Medical Device Distribution (draft). Deadline 4/10/2014. Fax: 86-10-88331441. Email to: [email protected]. http://www.sda.gov.cn/WS01/CL0779/97817.html

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Does anyone have a translated version of the WORD and Excel sheets? I tried Google docs. It is not complete. Thanks and appreciate your help.

TS

Will there be more details to these regulations coming out before June 1st, 2014?

Here is the english version of new CFDA MD regulations that I got from a friend.

Regards,
Sreenu

What would happen to the Application submitted before this date....would we have to change them?

Based on my previous experience for software regulations (April 2012), I believe CFDA will give you a supplemental notice to submit the documents for the gaps.

Regards,
Sreenu