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

B

bblbbblb

#1
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:
Elsmar Forum Sponsor
L

Lotus_zou

#2
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

#3
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

#4
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

#5
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

Involved In Discussions
#6
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!
 

QAengineer13

Quite Involved in Discussions
#7
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!
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.
 
Thread starter Similar threads Forum Replies Date
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 4
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
R Medical Device Smartphone App Regulatory Requirement and Labeling US Food and Drug Administration (FDA) 1
G Medical Device Power Inlet/Outlet Voltage Labeling IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
M When is a Manufacturing Date required on Medical Device Labeling? Other Medical Device Regulations World-Wide 12
P Medical Device OEM, OBL and Private Labeling Questions EU Medical Device Regulations 5
M Identification and labeling medical device replacement system components Other Medical Device and Orthopedic Related Topics 12
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
J Labeling for Repair Parts of a Medical Device Other Medical Device and Orthopedic Related Topics 1
K Medical Device Labeling Requirement in Mexico Other Medical Device Regulations World-Wide 2
K Medical Device Labeling Requirement - Manufacturer Name 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D US-EU Medical Device Labeling Consistency 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
J Sterile Medical Device Labeling Requirments - ISO 1041 Other Medical Device and Orthopedic Related Topics 1
A Are Medical Device Servicing Instructions Part of Labeling? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Medical Device Labeling Content Development ISO 13485:2016 - Medical Device Quality Management Systems 3
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
P Class 1 Medical Device Labeling and CE Marking Requirement EU Medical Device Regulations 8
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
T Requirements for Private Labeling a Class III (PMA) Medical Device in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Medical Device Battery Labeling Requirements in the US US Food and Drug Administration (FDA) 1
S Private Labeling Regulations - Medical Device from Canada into India Other Medical Device Regulations World-Wide 3
C Timescales for Changing Medical Device Labeling EU Medical Device Regulations 4
E Labeling Requirements for an Implantable Medical Device Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
D CE Mark Labeling Requirements for a Class II Medical Device EU Medical Device Regulations 3
J Labeling Software for Medical Device Product and Packaging Labels for Production Use Other Medical Device Regulations World-Wide 5
M Labeling a Small Class IIb Medical Device EU Medical Device Regulations 8
L Medical Device Labeling Requirements - EN:980:2008 Other Medical Device Regulations World-Wide 2
L Special Medical Device Labeling Requirements in Thailand Other Medical Device Regulations World-Wide 5
N European Medical Device Labeling Requirements - Electrical Muscle Stimulator EU Medical Device Regulations 11

Similar threads

Top Bottom