Argentina

REQUIREMENTSARGENTINA                   
New
Normal
Renewal
Normal
Major Variation
Normal
New
Fast Track
ClassClassClassClass
GENERAL REQUIREMENTIII aII bIIIIVIII aII bIIIIVIII aII bIIIIVIII aII bIIIIV
Section 1 Administrative Documents
Free Sale Certificate (from US)
Notarized Copy
Notarized original
Apostilled
ConsularizedXXXXXXXXXXXXXXXXXXXX
Free Sale Certificate from country of manufacture (if non-US)
(Consular stamps for Guatemala, Nicaragua , Costa Rica, Brazil; Apostilled for El Salvador, Honduras and Panama) from the country of origin.
Notarized Copy
Notarized original
Apostilled
ConsularizedXXXXXXXXXXXXXXXXXXXX
Certificate to Foreign Government (CFG)
Notarized Copy
Notarized original
Apostilled
ConsularizedXXXXXXXXXXXXXXXXXXXX
Certificate of Analysis (COA)
Specific lot
Random lotXXXXXXXXXXXXXXXXXXXX
Multiple (state number)
ISO Certificate
Notarized copyXXXXXXXXXXXXXXXXXXXX
Apostilled
Consularized
CE Certificate (Not a requirement, helps in the reg process)
Notarized copyXXXXXXXXXXXXXXXXXXXX
Apostilled
Consularized
Third Party Manufacturer Statement (GMP)XXXXXXXXXXXXXXXXXXXX
Letter of Authorization/Power of AttorneyXXXXXXXXXXXXXXXXXXXX
Country specific specialty letters
Samples of each code (if required in your country, please specify the amount)
Desirable not mandatory
Contracts and related documents
Country specific specialty letters (When applicable)
Justification letter of the change issued and signed by the manufacturer
Legal Documents for REGULATORY EQUIVALENCE WITH CANADA (for products registered in Canada)
a)Apostilled copy of the license of the MD issued by HC to the Title Holder
b)Current Compliance Certificate with Standard CAN/CSA-ISO 13485:03 Medical Devices of the manufacturing site duly apostilled.
c)Current compliance certificate with Standard ISO 17021 Conformity Evaluation duly apostilled.
d)Authorization that Health Canada issues to the Certifier that enables them to certify other companies duly apostilled.
e) Apostilled Title Holder POA to register, import, distribute, the product
f) Apostilled letter explaining the relationship between companies, involved in the manufacturing process.
Legal Documents for REGULATORY EQUIVALENCE WITH USA (for products registered in US)
a) Apostilled copy of the FDA 510K including product name and code numbers
b) If code numbers are not available in the 510K, a sworn letter issued by the manufacturer explaining which codes are included in the registration certificate.
c) Apostilled copy of the Establishment Inspection Report of every facility included in the manufacturing process.
d)Certificate of Foreign Government duly apostilled
e)Apostilled Title Holder POA to register, import, distribute, the product
f) Apostilled letter explaining the relationship between companies, involved in the manufacturing process.
NOTE: Mexican MoH requests that all legal documentation must be apostilled and must link all the relationships between manufacturer, distributor, marketing authorization holder, legal manufacturer, CE Representative and any other entity involved.
Section 2 Product Identification
Product NameXXXXXXXXXXXXXXXXXXXX
Generic Name
Product Code Number(s). A list when there is more than one code.XXXXXXXXXXXXXXXXXXXX
Global Medical Device Nomenclature (GMDN)
Device DescriptionXXXXXXXXXXXXXXXXXXXX
Phisical form or pharmaceutical form if applies or Qualitative & Quantitative Formulation
Presentations
Classification of the Device and rule
How the device functionsXXXXXXXXXXXXXXXXXXXX
Device attributesXXXXXXXXXXXXXXXXXXXX
Basic Scientific conceptsXXXXXXXXXXXX
Component materials and accessories used in its principles of operationXXXXXXXXXXXXXXXXXXXX
Intended UseXXXXXXXXXXXXXXXXXXXX
Indication for UseXXXXXXXXXXXXXXXXXXXX
Warnings, Advertencies and precautions or any other relevant information for the patientXXXXXXXXXXXXXXXXXXXX
Method for the discard or final disposition of the productXXXXXXXXXXXXXXXXXXXX
Spare part List (only for equipments)XXXXXXXX
Accessories List (only for equipments)XXXXXXXX
Information about if the product is to be implanted or has direct contact with a patientXXXXXXXX
Diagram of the device structure
Section 3 Global Regulatory Status
Product Registration StatusXXXXXXXXXXXXXXXXXXXX
FDA Clearance information
Section 4 Material and Components
Composite Bill of Materials. Include suppliers names and complete addresses.XXXXXXXXXXXXXXXXXXXX
Composite Bill of Materials
Device DrawingXXXXXXXXXXXXXXXXXXXX
Device Photo/PicturesXXXXXXXXXXXXXXXXXXXX
Raw Material SpecificationsXXXXXXXXXXXX
Description of Machine components (in case of hardware)XXXXXXXX
MEDICAL DEVICES THAT INCLUDE DRUG PRODUCTS:
FormulaXXXXXXXXXXXX
Formula signed in original by the Technical Responsible.XXXXXXXXXXXX
Description and function of each component in the formulationXXXXXXXXXXXX
Active ingredient:
Chemical, generic or International common description and commercial nameXXXXXXXXXXXX
Structure, molecular formula and relative molecular weightXXXXXXXXXXXX
Phisico-chemical characteristicsXXXXXXXXXXXX
Manufacturing process information: description, raw materials, critical steps in process and final controls.XXXXXXXXXXXX
API manufacturer (name and address)XXXXXXXXXXXX
Specifications and justification when are not included in pharmacopoeia
Analitical methods and validation when are not included in pharmacopoeia
Certificate of analysis
Additives:
Chemical, generic or International common description and commercial nameXXXXXXXXXXXX
Description of the additiveXXXXXXXXXXXX
Structure, molecular formula and relative molecular weightXXXXXXXXXXXX
Phisico-chemical characteristicsXXXXXXXXXXXX
Manufacturing process information: description, raw materials, critical steps in process and final controls.XXXXXXXXXXXX
Manufacturer (name and address)XXXXXXXXXXXX
Specifications and justification when are not included in pharmacopoeia
Analitical methods and validation when are not included in pharmacopoeia
Certificate of analysis
Specifications and justification when are not included in pharmacopoeia
Analitical methods and validation when are not included in pharmacopoeia
Certificate of analysis
Section 5 Manufacturing
Manufacturing location(s) - name and complete addressXXXXXXXXXXXXXXXXXXXX
Legal manufacturer information
Manufacturing location registration information
Manufacturing location inspection informationXXXXXXXXXXXX
Manufacturing location GMP inspection performed by the local Health AuthorityXXXXXXXXXXXX
Manufacturing Process Description. Brief description and Flowchart which includes the explanation of the whole process including third party steps.XXXXXXXXXXXX
Manufacturing SpecificationsXXXXXXXXXXXX
Manufacturing flow chart, which lists all applicable working instructions and test instructionsXXXXXXXXXXXX
Validation of Processes and Test Methods (specifically cleaning and sterilization validation)
Design Dossier Change HistoryXXXXXXXX
When the phases of the manufacturing take place in different facilities, and explanation is required.XXXXXXXXXXXXXXXXXXXX
Batch numbering system
Section 6 Quality Control
Identification of StandardsXXXXXXXXXXXX
Certificate of Electromagnetic Compatibility (Hardware only)XXXXXXXX
Design Basic Characteristics (Also known as Design Philosophy)
Analytical Methods and Validation
Analytical MethodsXXXXXXXXXXXX
Specifications and justification when are not included in pharmacopoeia
Finished Product Quality Control TestXXXXXXXXXXXX
Certificate of Analysis for finished products Certificate of Analysis (COA) (Specific lot/ Random lot / Multiple (state number)
Mandatory for Brazil (A certificate that documents a product batch/lot has met all manufacturing and quality requirements for the finished product. Also known as Batch Release Certificate/Finished Product CertificateXXXXXXXXXXXXXXXXXXXX
Raw material specifications, analytical methods and validation
Finish products QC analytical methods validation
Finish product specificationsXXXXXXXXXXXX
Certificates of Analysis for raw materials (active ingredient, additives, and components). COA from Baxter and from Supplier.
Recent and random lot. One COA per product code/model. The COA must include: Tests, Analythical Methods or Pharmacopoeial references, Specifications, Results (numerical when applicable), final disposition (approved) on letterhead paper, and signed in original by the Technical Responsible. For sterile products, sterility test and result must be included.
l - Hermeticity tests for sterile products.
Section 7 Packaging and Labeling
Packaging Description (primary and secondary packages)XXXXXXXXXXXX
Packaging MaterialsXXXXXXXXXXXX
Hermeticity test, if applicableXXXXXXXXXXXX
Copy/scanned/artwork of the Product LabelXXXXXXXXXXXXXXXXXXXX
Copy/scanned/artwork of the Package or Carton Label and/or Packaging photos or color artworksXXXXXXXXXXXXXXXXXXXX
Copy/scanned/artwork of the Instructions or Directions for Use/Operator's Manual/Direction Insert/Package InsertXXXXXXXXXXXXXXXXXXXX
Copy/scanned/artwork of the Brochure or Catalog PageXXXXXXXXXXXXXXXXXXXX
Electronic file of Operator's Manual (Hardware)XXXXXXXXXXXXXXXXXXXX
Label on shipping cartonXXXXXXXXXXXXXXXXXXXX
Insert in spanish
Section 8 Product Shelf Life
Determination of Shelf Life/Expiration DateXXXXXXXXXXXXXXXXXXXX
Validation of Expiration Dating/Stability Studies/Shelf Life Supporting StudiesXXXXXXXXXXXX
Explanation of Lot Numbering System
Storage conditionsXXXXXXXXXXXXXXXXXXXX
Section 9 Sterilization
Sterilization Method(s)XXXXXXXXXXXXXXXXXXXX
Validation of Sterility Method(s)
Sterilization ParametersXXXXXXXXXXXX
Technical Summary for the Sterilization Method(s)
Sterilization Site(s)XXXXXXXXXXXX
For reusable medical devices, include technical support that the product maintains original specifications
Section 10 Biological Testing
Biocompatibility/Toxicity ResultsXXXXXXXXXXXX
Identification of Biocompatibility StandardsXXXXXXXXXXXX
Technical Summary of Biocompatibility/Toxicity Testing MethodsXXXXXXXXXXXX
Justification letter when some test are not applicable
Support medical device with germicidal and antiseptic activity, when applicable
Section 11 Safety Information / Risk Management Documentation
Risk Assessment
Risk AssessmentXXXXXXXX
Risk Management PlanXXXXXXXX
Risk Management Report/Risk Assessment and Control Table (RACT)
Risk Management Summary Table/File IndexXXXXXXXX
Deferred Defect List and acceptability rationale
Technovigilance report
Report which includes the following information: Date of the report, period covered by the report, adverse events reported (information from the last five (5) years), generic and trade name, product monograph.
Alerts asociated with the product
Section 12 Clinical Investigation Data
Clinical Evidence (other than clinical trial) - (summary and conclusions of clinical trials (just for new products) and in accordance with its classification risk)XXXXXXXXXXXX
Summary of Safety and Effectiveness (Preclinical studies, if applicable)XXXXXXXXXXXX
Biological reactivity report for class II products non implants
Effectiveness evaluation results issued by Third party laboratory
Section 13 Other (Please specify)
Warnings, Advertencies and precautionsXXXXXXXXXXXXXXXXXXXX
Method for the discard or final disposition of the productXXXXXXXXXXXXXXXXXXXX
Monograph for Fast Track Applications signed by manufaturer
Sworn statement registration conditions have not been modified, apostilled
A. Product specifications
B. Manufacturing process Flow diagram
C. Sterilization method
D. Summary of Atoxicity and biocompatibility tests
E. Expiry date and stability study
F. Primary and secondary packing characteristics
G. Codes, models, presentations
H. Summary of Preclinical and clinical studies
I: Bibliographic references
Sterilization certificate (original and signed)
GMP Inspection
GMP certificate (apostilled)
CoA original and signed by responsible
Letter of Authorization to register, import and be the holder (apostilled)
Stability certificate (original and signed)
Explanation of Lot Numbering System (original signed)
Technical specifications of each code are necessary to indicate at least the following: dimensions, material, color, function of each component.
declaration of conformity and references including generic name
Approval Time (Months)966-8N/A
Fees (USD)50000N/A
INMetro Certification Brazil ( This certification is required for Dossier Submission)Class I & II sets Inmetro test are performed at local level. Electromedic Devices class I,II,III & IV test are required per unit and performed at origin manufacturing site.Electromedic Devices Requirements Class I,II,III & IV as follows:
The data required comes from INMETRO Ordinance #350:2010, RDC 27:2011 from ANVISA and Normative Instruction # 04:2015.We shall consider two different flows. They are:
A- Certification without tests
This one will be done based on tests already performed by a Laboratory accredited by an ILAC Member. The required docs are:
1. Quality System manual from manufacturer location and/or Assembly location;
2. Master list of quality documentation from manufacturer location and/or Assembly location;
3. Address of manufacturer and/or assembly location. For that, we need to receive beyond address, the name, e-mail and phone # of responsible person to be contacted by UL auditor in order to schedule the audit;
4. Evidence that power cord is certified according to ABNT NBR 14136 (certificate of power cord);
5. Photo or layout of INMETRO + UL mark;
6. Photo or layout where the INMETRO + UL mark will be applied on the device’s enclosure;
7. Photo or layout where the INMETRO + UL mark will be applied on the device’s package;
8. Customer complaint procedure (from Brazilian representative company);
9. Traceability procedure (from Brazilian representative company);
10. Risk Management File (RMF);
11. User’s manual in Portuguese;
12. Software version;
13. Biocompatibility evidences for all parts of device that be in contact with the patient, proving that those parts are in compliance with ISO 10993 series of standards;
14. Declaration that the product has not changed from the execution of the type tests stating that this premise is true and no changes have been made to the device since then;
15. Test reports according to applicable standards, issued by an ILAC Lab and no older than 2 years old. They are:
i. IEC 60601-1:2012 Edição 3.1;
ii. IEC 60601-1-2:2007;
iii. IEC 60601-1-6:2006;
iv. IEC 60601-1-8:2012;
v. IEC 60601-1-11:2015 and
vi. IEC 60601-2-X.
B- Certification with tests
1. The items A-1 to A-13 shall be provided;
2. One sample of device;
3. Schematics;
4. Mechanical drawings;
5. Bill of material (BOM) and
6. PWB layouts.
In order to allow us start the project we need to receive the following;
A- For no tests profile: Items A-10, A-11 and A-15. All of others can be provided during the process;
B- For tests: Items A-10, A-11, B-2, B-3, B-4, B-5 and B-6.

General country-specific regulatory information is provided on this page. Become a user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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Appointing a Brazilian Registration Holder Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian Registration Holder (BRH). Your BRH will submit your registration application to ANVISA and maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable. …