Medical Device Labeling - Order No. 6 Effective Oct 01, 2014

B

bblbbblb

From my understanding of this revised regulation both the Package Insert and Device Label now need to include both Date of Manufacture and Expiration Date as of October 01, 2014.

As we typically do not include manufacturing dates on IVD labels, has anyone else implemented this change? Anyone shipped product to China since Oct 01 without the DOM on the labelling?

Is anyone aware of any grace period for implementing this regulation. Our problem is we need to ship product that was manufactured before the date of this regulation, so do we now need to rework the finished to add the DOM before shipping?

Another one of the new regulations requires all labelling changes to be submitted to the CFDA for approval. So can this change to add the Date of Manufacture even be done without the prior labelling change approval from CFDA?
 
Last edited by a moderator:
L

Lotus_zou

Hi, no futher detailed information has been released from CFDA until now.
From my understanding, it requires Date of Manufacture + validity period or Expiration Date, either way is ok.
 
E

Erik Nielsen

Hi,

The Date of Manufacture + Validity period or Expiration Date may make good sense for products with a limited life time but what about medical devices where no such life time is defined? From my understanding the same rules apply to both IVD's and medical devices so will we have to invent an expiration date and how will that be understood by the users?
 
T

treesei

If you read Order #6 carefully, it says "in general" the labeling shall include a DOM and expiration date. So my interpretation is there is some room to be realistic.
 
E

Erik Nielsen

Hi Treesei,

Thank you for your fast response. It was the answer I had hoped for and using Google Translate on the Chinese text on the Order, I was able to find it.

Thanks, Erik
 
Gamula

Gamula

Involved In Discussions
Yo Folks,

A new regulation was issued by CFDA on Aug. 8th, 2017. :magic:

It is mainly about the draft for Announcement on Using Chinese for Name, Manufacturer’s Address, Address of Manufacturing Site of Registrant or File Submitter for Imported Medical Devices.

Via PN I can send you the respective CFDA link in Chinese. It can be easily translated by using google translator. :notme:

Cheerio!
 
Q

QAengineer13

Quite Involved in Discussions
Gamula said:
Yo Folks,

A new regulation was issued by CFDA on Aug. 8th, 2017. :magic:

It is mainly about the draft for Announcement on Using Chinese for Name, Manufacturer’s Address, Address of Manufacturing Site of Registrant or File Submitter for Imported Medical Devices.

Via PN I can send you the respective CFDA link in Chinese. It can be easily translated by using google translator. :notme:

Cheerio!
Click to expand...
Hi Gamula,

Could you please send Order 6 to me as well, thanks in advance, or if you could kindly post in the forum others can also benefit.
 
E

Edugar

Involved In Discussions
Hi all!
Looking at the previous messages, it seems pretty clear that the manufacturing date needs to be included in the label in China.
However, we now have a doubt regarding the inclusion of the manufacturing date in the UDI. In the Rules for UDI System (NMPA No. 66, 2019), Article 7 states that “production identification by the medical device production process information related to the code, according to regulatory and practical application needs, can contain medical device serial number, production batch number, production date, expiration date, etc..” (translated with DeepL).
Although this says that the manufacturing date CAN be included in the UDI (i.e., it is not an obligation), it seems that hospitals (and other parts of the supply chain) in China are requesting that it is actually always present. Does anyone have any experience with this matter? What is your approach with the manufacturing date in the UDI (in China or elsewhere)?
Thanks in advance for your help.
 
T

TimZhao

NMPAFocus
There doesn't have conflict between the Order No. 6 Effective Oct 01, 2014 and No. 66,2019 . even the production date already included in UDI, but it is mandatory to display the Production Date on Label itself.
 
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