Mexico Medical Device Registration Requirements

MDRexpert

Involved In Discussions
#1
Do we need to submit all of the quality information of the product to register our device? We are contract manufacturer in this case and this product will be branded under their name.

Biological Safety Clearance Report
Biological Safety Test Reports & Results
Certificate of Analysis/Compliance
Quality Tests according with COA
ETO Residuals Certificate
Pyrogenicity Evaluation
Certificate of Sterility/Conformity
Clinical Evaluation (CDR)
Design History File
Device History Record (obtained from Mfg site)
Global Market History
Commercialization History Report
Complaint History Report (CHR)
Post Market Surveillance
Manufacturing Process (Flowchart), with a detailed data about in-process and final tests.
Material/Raw material Certificates with results
Pack Integrity Test / Packaging Validation, Reports
Packaging material information and images
Performance Test (Protocol & Report)
SOP's (& DP's)
Shelf Life accelerated ageing (Protocol and Report)
Shelf Life Real time (Protocol and Report)
Shelf Life Rationale ( Real time or accelerated ageing)
Stability Studies accelerated ageing (Protocol & Report)
Stability Studies Real time (Protocol & Report)
Stability Studies Rationale (Real time or accelerated ageing)
Sterilization Method (Protocol & Reports)
Sterilization Validation (Protocol & Reports)
Standards - (Essential Requirements or Standards compliance Report)


Please advise/suggest. Thanks!
 
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pziemlewicz

Involved In Discussions
#2
Usually the person who markets the device is responsible for registration, not the contract manufacturer.

Most of your list does need to be submitted, however the Design History File (DHF) and Device History Record (DHR) are maintained onsite and must be made available for review upon request.
 
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