C of C (Certificate of Compliance) for Production Batches of Medical Devices

S

ssarangapani

#1
Hello Medical Device Experts:
I have been asked to submit Certificate of Compliance for three most recent batches of our product by Mexican Regulatory authorities - as part of paperwork related to gaining approval in Mexico. Our product is ISO13485 certified & CE mark approved. The final product is assembled and released by a sub-contractor. Should we ask our sub-contractor to issue the certificate or should we do it, since, we are the Registered manufacturer and Specification Developer?

Also please let me know a template to use for the C of C.

Thanks,

SS from Norwood MA
 
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somashekar

Staff member
Super Moderator
#3
Hello Medical Device Experts:
I have been asked to submit Certificate of Compliance for three most recent batches of our product by Mexican Regulatory authorities - as part of paperwork related to gaining approval in Mexico. Our product is ISO13485 certified & CE mark approved. The final product is assembled and released by a sub-contractor. Should we ask our sub-contractor to issue the certificate or should we do it, since, we are the Registered manufacturer and Specification Developer?

Also please let me know a template to use for the C of C.

Thanks,

SS from Norwood MA
Nothing short of you submitting the C of C will meet the requirement.
The final product is assembled and released by a sub-contractor.
This is the way you do business and has no bearing with the Mexican Regulatory authorities, as long as your products meet the requirement and one of the requirement as you mention is the C of C and this has to come obviously from you.
Our product is ISO13485 certified & CE mark approved.
A product cannot be ISO13485 certified. However as you CE mark the product, your D of C will be a good start to help you make the C of C.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hello Medical Device Experts:
I have been asked to submit Certificate of Compliance for three most recent batches of our product by Mexican Regulatory authorities - as part of paperwork related to gaining approval in Mexico. Our product is ISO13485 certified & CE mark approved. The final product is assembled and released by a sub-contractor. Should we ask our sub-contractor to issue the certificate or should we do it, since, we are the Registered manufacturer and Specification Developer?

Also please let me know a template to use for the C of C.

Thanks,

SS from Norwood MA
A CoC is just an authorized statement that a certain batch meets (complies with) a certain specification. The specific wording is not very important, as long as it's clear what product you are referring to, what batch(es) and what specification. Sign and date, optionally stamp, and you're good to go.

Cheers,
Ronen.
 
S

ssarangapani

#7
In response to Somasekhar's comment:
I agree. ISO 13485 if for our quality system, and not for the product. It was a typing error. Thanks for pointing this out,
SS
 
L

lamorenita_QA

#8
Hello our complany received a minor finding from CB auditor rgarding ISO 13485 7.5.1.1-Process control. Desc of nonconformity-the process for verifying and approving batch records is not sfficiently effective. Supporting audit evidence-reviewed lot control records provide not sufficient evidence for formal verification and approval of the 'batch records'. Specifically this addresses our component date lot code entry in our pick list,of closed work order were missing evidence of verification and approval. Our action plan is to state when the component date lot codes are entered by our stockrom and floor stock personnel, this is the verification requirement, and at the end of the completed work order- a final QC inspector will sign and final approval of the batch record. If anyone has a similar problem with a better action plan, I would appreciate your advice. BTW, our MRP system is not sophisticated enough to automate this process, it needs to be perfomed manually.:confused:
 
S

ssarangapani

#9
In our component fabrication list, we have a place for signature of the line worker and a supervisor. When we assemble the lot records, we staple all the component records together, which have the approval signatures.
I beleive you can also create a table of lot codes of components and expiry dates, for a given batch and obtain signature from both the line worker and the supervisor.
SS from NOrwood:)
 
L

lamorenita_QA

#10
Thx! this is general how our action plan is laid out, but haven't tried it out yet, has this worked for your company well?
 
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