REQUISITOS PARA EL TRÁMITE DE REGISTRO SANITARIO DE ...€¦ · Dispositivos Médicos Clase I...

REQUISITOS PARA EL TRÁMITE DE REGISTRO SANITARIO DE DISPOSITIVOS MÉDICOS Homoclaves: COFEPRIS-04-001-A, COFEPRIS-04-001-B y COFEPRIS-04-001-C

Dispositivos Médicos Clase I conforme al Art. 83 del Reglamento de Insumos para la Salud

CAS/DEAPE/SESSDM NMV/MINS/CTG VER. 29/07/2014

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LEGAL AND ADMINISTRATIVE

INFORMATION

LEGAL BASSIS TO SUPPORT IT IS A

REQUIREMENT FOR REGISTRATION

ELEMENT THAT INTEGRATES THE REQUIREMENT

CRITERIA STANDARD COMPLIES REFERENCE NUMBER IN THE

FILE YES NO

1.1. Application form • Art.153 RIS • Art. 14 LFPA. • Agreement

Original of application form in two sets Is the format published by Cofepris to carry out the application procedures related to the registration of the product. Current format of authorizations, certificates and visits. Duly filled, the items that do not apply to your application must be canceled with a parallel line, signed by the owner, legal representative or health official.

Agreement. Filling Guide

1.2. Accreditation of legal representative

• Art. 15 LFPA Original or certified copy of a

notarized power of attorney.

It may be submitted simple copy of a certified copy referencing in which proccess the orginal document is located. Note: It will only be valid the simple copy as long as the referenced original document has maximum two months of being submitted.

Summit original or original of certified copy of a notarized power of attorney in favor of the Legal Representative in Mexico through which the company gives broad powers to perform the registry procedures of of the medical devices (article 262 LGS). The Legal Representative must be the same as the one who signs the format of Applications.

1.3. Payment of fees • Art. 195-A LFD. • Agreement

Original Voucher Payment, plus two copies

a. Quota established by the LFD b. In the case of bank payment: bank seal and date c. Printing of electronic payments in three sets

Tariffs stated in the Federal Fees Law.




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1.4 Notice of operation • Art. 181 RIS Simple copy of the notice of operation In case of requesting to include more than one distributor, the corresponding operating notices must be summited.

Formats submitted to the authority to notify the data of the establishment where it is physically carried out an activity related to the process of medical devices additional to the fiscal domicile of the establishment.: Copy or reference numeber of the notice off operation with the following elements or characteristics: - Name of the Company: - Address: -Authorized Classification: -Manufacturing Lines: must include the product requested - Date of Issue - Signature - Entry stamp in CIS a- The notice must correspond with the data of establishment settled on the format. b- Include or attach a simple copy of the notice (s) c- The data expressed in the SCAIN code should correspond to the line of business of the establishment according to the related activity. d- In the case of radiation sources for medical use submit a copy of the license issued by the Secretary of Energy. e- In the case of radiation sources license data must correspond with the data of the company.

Database of Sanitary Licences from the Executive Sub-directorate

1.5 Notice of Public Health Compliance Officer

• Art. 259 LGS

NOM-241-SSA1-2012, Good manufacturing practices for establishments dedicated to the manufacturing of medical devices

Summit simple copy with the following data: a) Public Health Compliance Officer b) Professional Certificate ID

With name and signature of the owner or legal representative. The health official must match the person who supports the technical information. The health official must comply with the profile indicated in NOM-241-SSA1-2012




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INFORMATION





FILE YES NO

1.6. Label and back label projects

•Art. 179 II • NOM 137-SSA1-2008

Label and back label original project and copy of it in a CD (in Word format)

Full or complementary information (back label) in Spanish language in terms of Official Mexican Standard SSA1- 137 2008. Can optionally use the symbols included in the normative appendices A and informative B of this standard. Reusable sterile medical devices must indicate in the instructions for use or proposed label or back label (label) the methodology to be used for re sterilization.

1.7. Free Sale Certificate or equivalent document for foreign manufacture.

Art 180 fracc. I RIS Art. 153 RIS FEUM Guidelines

Free Sale Certificate or equivalent document issued by the health authority of the country of origin. Equivalent documents: 1. Letter issued by the health authority of the country of origin stating that these products are not subject to sanitary control. 2. Document issued by the respective Ministry to regulate medical devices in the country of origin. 3. Results of the clinical study or research protocol carried out in national territory according to what is stated in the regulation of the General Health Law in the Field of Research. 4. In the case of tolling, Certificate of free sale of the country for which the product will be manufactured or Certificate of free sale issued in the country in which the product is manufactured or in which the business relationship and/or supply is established. (The criterion 4 is in consultation with legal department)

a. To. Original or a copy certified by a notary in Mexico. b. Authenticated: 1) Apostille. The Apostille can only be issued by a competent authority designated by the State from which the document emanates from, or 2) Legalized (by Mexican consul in the country of origin) for countries not belonging to the Hague Convention c. Spanish language translation by expert translator in Mexico. They do not require translation into Spanish documents of origin that are issued bilingually and that include the Spanish language d. Current document. Failure to declare the term in the document, the issuance thereof shall not exceed 30 months.. e. The document shall endorse: product (brand name models and as the case may be), Legal Manufacturer and/or manufacturing site, list of codes of presentations, as the case may be.




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INFORMATION





FILE YES NO

1.8. Good manufacturing practice certificate (GMP) of establishment (s) manufacturer(s) of medical device (s) or its equivalent document.

Art. 179 fracc. VI RIS Art. 180 fracc. III RIS Art. 153 RIS

National Manufacturing: Good manufacturing practice certificate issued by Cofepris. Foreign Manufacturing: Good manufacturing practice certificate issued by the health authority of the country of origin or its equivalent document. Equivalents: • ISO 13485 certificate current version issued by approved organism. • CE mark certification for medical devices issued by by authorized agency in the European Union. • Declaration of compliance with Good Manufacturing Practices included in the Certificate of Free Sale issued by the Health Authority or the respective ministry to regulate the product.

National Manufacturing: Certificate for good manufacturing practices issued by the COFEPRIS: 1. Simple Copy that expresses: name, address, date of issue and validity. Foreign Manufacture: Original or certified copy of the certificate of good manufacturing practices or the equivalent document for the manufacturing site or sites.. 1. Apostilled or legalized (by Mexican consul in the country of origin.) 2. Translated into Spanish by an expert translator in Mexico. They do not require translation into Spanish documents of origin that is issued in bilingual or trilingual forms that include the Spanish language. 3. Current document. Failure to declare the term in the document, the issuance thereof shall not exceed 30 months.




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1.9. Tolling agreement if applicable

Agreement FEUM Guidelines

For National Manufacturing: Tolling agreement signed by both parties before a public notary. Submitting simple copy of the certificate of good manufacturing practice issued by COFEPRIS, valid and that endorses the current site and production line.

For Foreign Manufacturing (contract manufacturers): Legal document that proves the relationship between manufacturers, legal responsibility to ensure compliance with regulatory requirements, their responsibilities in the quality of the product to register, notarized certification of origin. (Only to deliver the section where the relationship of manufacturing, responsibilities in the quality of products and/or supply are established). Submitting a certificate of good manufacturing practice in original or certified original copy issued by the health ministry of the country of origin or certification organism, valid and that endorses the site and production line with a Spanish translation by expert translator (certified by the High Court of Justice)

Simple copy, for any of the two cases




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INFORMATION





FILE YES NO

1.10 Letter of representation only when the product is not manufactured by the parent company, subsidiary, or affiliate of the registrant in Mexico

Art. 180 fracción II y Art. 161 fracc. III RIS Agreement

Letter of representation original or certified copy only when the product is not manufactured by the parent company, subsidiary or affiliate of the party requesting registration in Mexico. In case of requesting to include more than one distributor a letter of representation shall be submitted for each one of them.

Document issued by the legal representative or responsible manufacturer, which grants the rights to commercialize and distribute its products to a company established in national territory. a. Should only be submitted if the product is not manufactured by the parent company or subsidiary of the company, factory or laboratory applying for registration in Mexico. b. In Spanish or translated into Spanish by a certified translator. c. Apostilled or legalized (by Mexican consul in the country of origin). d. Issued by the manufacturer responsible abroad. e. Granted to the company requesting the registration in Mexico.




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SCIENTIFIC AND TECHNICAL

INFORMATION FOR SAFETY AND

EFFECTIVENESS

LEGAL BASSIS TO SUPPORT IT IS A REQUIREMENT FOR

REGISTRATION



FILE YES NO

2.1 Statement of endorsement under oath of the corporate health compliance officer to COFEPRIS

Art. 153 RIS

Original letter of endorsement statement of health official to support the technical information presented and, when necessary, the translation. The registrant defines the scope of the letter, which must specify the technical documentation involving this responsive. And must sign the first page of each section of the technical documentation submitted.

2.2 General information FEUM Guidelines

Document issued by the registrant in Mexico

1. Generic name. 2. Commercial name. 3. Physical form or pharmaceutical 4. Presentations 4.1 In the case of having several presentations include the list of product presentations, including keys and its description, being able to include commercial catalogue that contains information purposes only. 5. Purpose of use. 6. Category and classification based on the level of health risk. 7. List of accessories and components for the registry of equipement, may include a list of accessories to be supplied with the same so that they may be included in the registry, if applicable.

2.3 Instructions ,if necessary, for use , insert or manual operation or prospect

Art. 179 fracc III RIS. FEUM Guidelines

Original or hard copy and/or in electronic format not editable in Spanish language.

It shall contain as a minimum the following information depending on the type of information product: 1. Trade name where appropriate, generic name. 2. Description 3. Intended use and method of use. 4. List of components or parts 5. Assemble disassemble 6. Operating and Cleaning 7. Storage conditions and storage 8. Maintenance 9. Calibration




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10. Precautions 11. Preparation, if applicable 12. Warnings and allusive legends 13. Contraindications 14. Adverse events Delivered one set, both, the manual and label and black label must be printed and in electronic format.




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EFFECTIVENESS




CRITERIA STANDARD COMPLIES REFERENCE NUMBER IN

THE FILE YES NO

2.4 Composition , description or diagram of the functional parts of the product

Art. 179 RIS FEUM Guidelines

Description, image, composition or diagram of functional parts

Applies to medical devices not formulated and their accessories a. Mark of which parts is conformed the product (mainly medical equipment). b. List of materials used in the medical device indicating the name and composition of the materials that integrate or are include in it, pointing the function they perform. (Applies to medical devices that are in contact with the patient, tissue or fluid corporares as fpr solutions for administration to the patient) c. Design chart or diagram representing dimensional specifications that represent the medical device

2.5 Declaration of qualitative, quantitative formula per unit of measure, percentage or dose for formulated products

Art. 179 RIS FEUM Guidelines

Document that contains the description of the qualitative and quantitative formula.

Statement of qualitative and quantitative formula per unit of measure, dose or percentage, for formulated products, including all the ingredients of the product, duly signed by the responsible for the quality of the manufacturer in the country of origin, or by the health compliance officer of the establishment requesting the health registry in Mexico.

2.6 Raw materials 268 LGS 14 RIS FEUM Guidelines

Certified copy of the analysis of the raw materials with which to prove identity, purity, sterility, where appropriate, harmless, safety, security, stability, as applicable.

Applies to products in contact with the patient (eg. Ointments against chafing) Must present a certificate of analysis of raw materials with results of chemical analysis, physical, mechanical and other established according to FEUM tests, international Pharmacopoeias or international standards issued by the manufacturer and signed by the quality manager. Certificate of Analysis of raw (stainless steel, titanium and other applicable) material for medical devices made not in contact with the patient or body fluids

.




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EFFECTIVENESS





THE FILE YES NO




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2.7 Laboratory tests RIS Art. 179 fracc. VII Laboratory tests to verify the specifications of the input When using methodology other than Pharmacopeial or comply with an international standard, it shall submit a description of methods of analysis or methodology (procedures) and its summary report of validation of the method used by the manufacturer to verify compliance specifications, according to the nature and characteristics of the device, except medical equipment.

Diagnostic agents or hygiene products: performance tests in accordance with the rules in force. In case of analytical reagents containing blood products (components of human origin) must submit a certificate of absence of HIV antibody, hepatitis and syphilis. Complete electrical testing reports, can be without limitation CB Report, UL report, IECEE Standard, ISO Standard etc., as applicable

2.8 Manufacturing process information

Art. 179 fracc. IV

Brief description or flow chart of the manufacturing process of the product.

It can be submitted through a:

a) Flowchart of the manufacturing process that identifies each of the steps, sub process and process controls, issued by the manufacturer, or b) General survey of the manufacturing process that identifies each of the steps, sub process and process controls, issued by the manufacturer

2.9 Sterilization for those products that hold the legend of sterile

FEUM Guidelines

Summary of the process of sterilization and sterility certificate

Information on the sterilization process. For sterile products or items that are used in sterile products the registration applicant must provide the following information: 1. Type of sterilization process. 2. Summary of the validation of the sterilization process: brief description of the process that was carried out with the evaluated parameters, results obtained and conclusions. 3. In case that that the sterilized medical device is reusable, it shall be submitted the reports and/or documentation demonstrating that the product maintains its original specifications during the processes of re sterilization indicated by the manufacturer. 3.1. Reusable sterile medical devices must indicate in the instructions for use or project label or back label (tag) the methodology to be used for re sterilization and the number of cycles that can be applied to the product. 4. Disposable sterile medical devices should include in the project label or back label (tag) an allusive legend




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that the product is disposable, or no reusable.

5. Certificate of sterility with microbiological results issued by the evaluation assessment officer, (only in the event that the analytical certificate of the finished product does not include this parameter).

6. In the event that sterilization is ethylene oxide should present the results of the test of ethylene oxide residues. (add)




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EFFECTIVENESS





THE FILE YES NO

2.10 Packaging information

FEUM Guidelines

Description of the components of the primary packaging and secondary in its case.

Description of the packaging material, primary and secondary in its case. Information on the packaging. For all medical devices except medical equipment, the registrant must include de following information. 1. Brief description of primary packaging and the secondary, if applicable, noting the materials used in the manufacture of it.

Physical and / or chemical interaction, that can alter its quality, exceeding the limits stated in the individual monograph; not toxic




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EFFECTIVENESS





THE FILE YES NO

2.11 Analytical certificate or product certificate

Art 179 RIS Art.180-IV RIS NOM-241- SSA-2012

Document issued by the quality assurance officer of the product or by the manufacturer in where they are declared the parameters to evaluate and the results of the same batch or serial number, must be issued on letterhead of the company name responsible for its issuance. According to the nature and characteristics of the device description must be submitted to the methods of analysis or methodology (procedures) that uses the manufacturer to verify the compliance with specifications, may submit additionally copy of the international standard or formal method used. For methods of physicochemical and / or biological analysis, in case of not being pharmacopeia methods a summary of the validation report, with which it is shown that it is consistent and reproducible must be submitted

Documents that are equivalent to the certificate of analysis, which can be submitted in accordance to the type of device, presented in an illustrative but not exhaustive way: 1. Document issued by the manufacturer or the legally responsible for the manufacture in where they are declared the parameters to be measured and the results of the same batch or serial number. In this case they must be submitted separately the acceptance criteria or specifications endorsed by the responsible for the quality of the product or health compliance officer in Mexico

2. Certificate of Compliance issued by the legal representative of the manufacture or manufacturer or authorized organism where it is stated that the product meets the criteria set by the company. In this case it must be presented separately the evaluated parameters and its acceptance criteria signed by the health compliance officer in Mexico

3. Copy of the registration in the manufacturing of the product (“Device History Record”, “Batch Production Record”, Routers, Shop floor paperwork ((SFP)), and Final Inspection Report (FIR), which must declare as minimum name or product ID or key number or catalog, lot number or serial number, date of manufacture and the results of qualitative or quantitative acceptance, according to the type of device, showing that it is manufactured according to the specifications of the manufacturer.

4. Certificate of conformity of electrical tests, they may be but not limited CB Report, Report

Is the document that ensures that the product has been tested prior to release of the plant to ensure its safety, effectiveness, quality and functionality after it has been shown compliance with the parameters of acceptance, established on the type of product based on.




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UL, IECEE standard, ISO standard etc.

5. Protocol for the liberation of product, report of quality control (results of the tests carried out during the manufacturing process as the finished product), and must show specifications, results, lot number or serial number, signed by the quality assessment officer.

5. Declaration of Conformity issued by the manufacturer or responsible for the quality of manufacturing or approved organism where it is stated that the product meets the requirements for commercialization and usage based on international quality standards, attaching the full reports evidence., only if it is specific to a batch or serial device to register. Likewise, when the statement does not indicate, it must be submitted separately supplementary document to support the safety and efficacy such as:

• The parameters evaluated and acceptance criteria signed by the manufacturer's quality officer,

• IEC studies, or

• Audit Report, or

• Product Performance Qualification (PPQ), or

• Master Validation Report (MVR), or

• Design Verification Report (DVR)

7. Copy of the summary of the verification report of the medical device (“Device Verification Report” / “Test Verification Report”).

General Considerations:

The certificates of analysis with electronic signature will be accepted as long as the declared information is endorsed by the Health Compliance Officer.




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EFFECTIVENESS




CRITERIA STANDARD COMPLIES REFERENCE NUMBER IN THE FILE

YES NO

2.12 Stability studies for those medical devices which by their nature and purpose of use require an expiration date display

Art. 85 RIS NOM-241- SSA-2012 FEUM Guidelines

Summary and conclusions of the stability studies in the proposed primary container, demonstrating the expiration period.

Stability studies. For those medical devices that by their nature and purpose of use require displaying an expiration date, must assess that the device retains its physical, chemical and biological properties, quality characteristics established to fulfill the purpose for which it was designed. Must present summary containing: Name of the medical device, presentations, number of lots tested, lot size, composition packaging (where applicable), conditions of the study, test parameters, acceptance criteria and reference methods of analysis, times of sampling and analysis, analytical results by storage condition and date of analysis, evaluation data and conclusions. According to the characteristics and nature of the device, the expiration period tentative obtained with an accelerated survey must be confirmed with long-term studies. The summary and its conclusions must be reviewed and signed by the unit responsible for the quality of the manufacturer or by the health compliance officer of the applicant establishment for the health registry in Mexico. The stability studies can be accelerated or in real time. The manufacturer shall establish a methodology and test conditions based on the characteristics of the product to ensure that during the period of life recommended are preserved the original features.




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2.13 Biocompatibility tests

FEUM Guidelines

Complete reports of the biocompatibility tests depending on the type and class of the device

When it applies according to the characteristics of the medical device Reports of tests to verify that the nature and the contact time of a product meets safety specifications either as: 1. The Mexican pharmacopoeia or other recognized pharmacopoeia or Mexican Official Standards or developed tests to specifications of specialized agencies (include corresponding reference of the relevant international standard), or other international recognized scientific bibliography. 2. Biocompatibility testing can be carried out both in finished product or raw materials used to manufacture the product. 3. For widely known materials may be used summaries of evidence applied to other medical devices of the same material and intended use, as long as it is justified with technical information that can be correlated to an equivalent product which shows similarity in composition and purpose of use 4. For all the materials widely recognized and that their quality and biological safety is supported by an international standard (ISO, ASTM, ADA, DIN, ANSI), it may be submitted the bibliographic references of the material with the certificate of analysis that will endorse the raw material. (All input that is in contact with the patient, with body fluids and solutions delivered to the patient must submit complete biocompatibility reports without exception) Biocompatibility reports must be submitted complete, signed and with complete simple translation.

ISO 10993




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2.14 Clinical studies FEUM Guidelines

Full reports of clinical studies and copy of the publications. May submit publications of studies for equivalent or similar products. Integrating justification by a report containing technical data and the evaluation of experts in the area, to substantiate the similarity of the device.

When applicable Translation, of full report In case of publication, shall be at least 3 as a minimum. If there are no posts, it can be submitted a letter explaining that studies of other manufacturers are included, only in the case concerned the same material and indication of use of the medical device to register. And where applicable present preclinical studies.




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(1) NOTE: It can be submitted clarification letters issued by the manufacturer, compliance health officer, legal representative or registrant, as applicable, when

required to explain some point in the file, to rectify discrepancies among others to correct discrepancies among others for example: trade name vs design name,

assignment of rights between manufacturers, differences in business name between manufacturers and any difference in the technical information.

(2) Agreement: AGREEMENT by which it is disclosed the procedures and services, as well as the formats used by the Ministry of Health, through the Federal

Commission for the Protection against Sanitary Risk, registered in the Federal Register of Formalities and Services of the Federal Commission Regulatory Improvement

(published (a) in the Official Journal of the Federation on January 28, 2011 and amended on June 22, 2011, 10 May, 18 July to 23 October 2012 and July 7, 2013.

(3) All documents accompanying applications must be submitted in Spanish, or otherwise, shall be attached thereto a translation in Spanish, endorsed with the

signature of the Health Compliance Officer. (Art. 153 of the Health Inputs Regulation).

(4) In the case in which the grouping of medical devices per family is required it should be considered: belonging to the same manufacturing site, they are made of the

same material, which belong to the same manufacturing line, that the purpose use is specific, that generic product has the same commercial or distinctive name.

(5) In the case of the group of medical equipment and diagnostic agents, they may include accessories and components that part of the same equipment and

necessary for the performance of their duties.

(6) This document is a guide for assembling of dossier for obtaining health registration of inputs Chapter IX of Title II of the Regulation of Health Products referred to,

however this does not exempt compliance with technical and legal requirements under applicable law.

REQUISITOS PARA EL TRÁMITE DE REGISTRO SANITARIO DE ...€¦ · Dispositivos Médicos Clase I...

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