How To Obtain Medical Device Approval in Mexico
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How To Obtain Medical Device Approval in Mexico

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Explains the medical device registration process in Mexico. Covers device classification, COFEPRIS regulations, Mexican Registration Holder, import requirements and more.

Explains the medical device registration process in Mexico. Covers device classification, COFEPRIS regulations, Mexican Registration Holder, import requirements and more.

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  • 1. The Medical Device Regulatory Process in Mexico The Medical Device Regulatory Process in MexicoAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 2. The Medical Device Regulatory Process in Mexico Key Topics • Overview of the Equivalency Agreements • Who are eligible to submit under these Agreements • Options for those that are not eligible • Overview of the Classification system • Appointing a Mexico Registration Holder • Documents required to submit the registration • How to prepare the application • Additional device requirements • Adding distributors to the regsitration • Transferring registrations • Ongoing complianceAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 3. The Medical Device Regulatory Process in Mexico Overview of COFEPRIS Equivalency Agreements • COFEPRIS released equivalency with Health Canada and US FDA in October 2010; effective as of January 2011 • Additionally published an equivalency with Japan in January 2012, effective February 2012 • Intent: – Push through backlogged submissions and expedite the registration process – Official approval timeframe is 30 working daysAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 4. The Medical Device Regulatory Process in Mexico Who is eligible to submit? • US FDA: – Class I, II, III devices all eligible – Must be able to provide: • Establishment Inspection Report (EIR) • Certificate to Foreign Government (CFG) • Class II, III devices: history of adverse events • Proof of listing, clearance, approvalAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 5. The Medical Device Regulatory Process in Mexico Who is eligible to submit? • Health Canada: – Limited to Class II , III, and IV devices – Class I devices are NOT eligible – Must be able to provide: • Medical Device License • ISO 13485 Certificate with CMDCAS • Standards Council of Canada accreditation to registrar • ISO 17021 certificate of the registrarAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 6. The Medical Device Regulatory Process in Mexico Who is eligible to submit? • Japan: – Limited to Class II Ninsho, Class II, III, and IV Shonin products – Class I Todokede products are not eligible – Must be able to provide: • Certificate of Free Sale • Certificate of Export • Proof of certification or approvalAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 7. The Medical Device Regulatory Process in Mexico Equivalency Agreement: Non-Eligible Companies •Standard Registration Process oReview direct by COFEPRIS, or oThird Party Reviewer UNIVERIX TAPVS NYCE Class I: 30,000 MX Class I: $50,000 MX Class I: $35,000 MX Class II: $48,000 MX Class II: $100,000 MX Class II: $55,000 MX Class III: $70,000 MX Class III: $150,000 MX Class III: $65,000 MXAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 8. The Medical Device Regulatory Process in Mexico Mexico’s Classification System Class I Class Ia Class II Class III Level of risk to patient/userAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 9. The Medical Device Regulatory Process in Mexico Classification System • Manufacturers must still register under COFEPRIS’ classification system – Class I, Class “Ia” notification, Class II, Class III • Classification Criteria semi-equivalent to EU Medical Devices Directive 93/42/EEC: o 18 Rules, plus 2 additional o Rule 19 – HIV/AIDS, Hepatitis B, Hepatitis C o Rule 20 – Hygiene productsAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 10. The Medical Device Regulatory Process in Mexico Classification System, cont’d. • The following is also used to classify devices: o List of 1669 deregulated medical devices o List of 96 Class Ia devices o HS Codes Listing used by customs, published by the Ministry of Economy in conjunction with COFEPRISAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 11. The Medical Device Regulatory Process in Mexico Classification System, cont’d. • Products must be grouped in accordance with COFEPRIS guidelines. Sample criteria: o The same type of product with its different presentations or models may be included providing that they are of the same material, formulation or composition and intended use, such as catheters, probes, surgical sutures, disinfecting solutions, among others. o Those products that have the same indication, intended use, or model may be registered as a system, for example: coronary stent systems, systems for blood fractionation, hip prostheses, spinal systems, knee systems, among others. o If the generic product has the same commercial or distinctive trade name, same indication or intended use. o If the products are fabricated by the same manufacturer or its subsidiary, or by a contract manufacturer authorized by the manufacturer or owner of the product.AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 12. The Medical Device Regulatory Process in Mexico Classification System, cont’d. Examples of Class Ia Devices: •Cotton, dressings, gauze, band-aids •Optical and surgical microscopes •Motion exercisers •Collars, splints, immobilizersAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 13. The Medical Device Regulatory Process in Mexico Classification System, cont’d. Examples of Deregulated Products: •Hospital beds •Stand-alone software •Stretchers, walkers •ScalesAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 14. The Medical Device Regulatory Process in Mexico Appointing a Mexico Registration Holder (MRH) • Manufacturers with no local presence in Mexico must appoint a Mexico Registration Holder (MRH) to act as their in- country regulatory representative and liaise with COFEPRIS • MRH must have licenses in order to submit device registrations – Aviso de Funcionamiento (Operating License) – Aviso de Responsable Sanitario (License of the Responsible Person)AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 15. The Medical Device Regulatory Process in Mexico Mexico Registration Holder, cont’d. • MRH will be named as the applicant and master distributor on registration certificate • Only MRH can authorized changes to the registration, such as: – Model additions – Distributor additions – Registration transfer – Registration renewalAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 16. The Medical Device Regulatory Process in Mexico List of Documents Required to Submit the Application under US/Canada Equivalency • Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements – Product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for useAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 17. The Medical Device Regulatory Process in Mexico List of Documents Required to Submit the Application under Japan Equivalency • Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements • Notification of Exportation • Original Certificate of Free Sale with codes; no older than one year • Certification issued by the Registered Certification Body or MHLW: – Description – Indications for use – Formula and/or composition, if applicable – Stability information, if applicable – Sterility period, if applicable – Primary and secondary packaging information, if applicable – Compliant labeling, instructions for useAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 18. The Medical Device Regulatory Process in Mexico List of Documents Required to Submit the Application under the Standard Process • Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof of home country approval – Detailed product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for useAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 19. The Medical Device Regulatory Process in Mexico List of Documents Required to Submit the Application under the Class Ia Process • Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Compliant labeling, instructions for use (Companies have 5 years from publication in Official Diary to comply with Class Ia registration)AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 20. The Medical Device Regulatory Process in Mexico Additional Requirements • Radiation Emitting Devices – License issued by Secretaria de Energía/Ministry of Energy (Comisión Nacional de Seguridad Nuclear y Salvaguardias) • HIV/HCV Test Kits, Condoms – Certificate of Analysis evaluation results from an authorized laboratory in MexicoAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 21. The Medical Device Regulatory Process in Mexico How to Prepare the Application 1. MRH makes payment to COFEPRIS on Manufacturer’s behalf, based on classification 1. Class I: MX $8,932 (≈ US $700) 2. Class II: MX $13,100 (≈ US $1,000) 3. Class III: MX $16,673 (≈ US $1,300)AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 22. The Medical Device Regulatory Process in Mexico How to Prepare the Application 2. Complete Applicable COFEPRIS FormAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 23. The Medical Device Regulatory Process in Mexico How to Prepare the Application, cont’d 3. Provide all documents required based on eligible registration route 1. All documentation must be provided in Spanish 2. Note, proposed labels must be in accordance with COFEPRIS Guidance Document NOM-137-SSA1-2008: http://www.cofepris.gob.mx/MJ/Documents/Normas/137ssa1.pdfAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 24. The Medical Device Regulatory Process in Mexico How to Prepare the Application, cont’d 4. Submit to COFEPRIS’ office in Mexico City 1. Must physically submit the application 5. Status can be checked on COFEPRIS database 6. Responses to and from COFEPRIS during review must be physically picked up and dropped offAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 25. The Medical Device Regulatory Process in Mexico Completion of Registration • Upon completion of its review of your device, COFEPRIS will issue a certificate.AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 26. The Medical Device Regulatory Process in Mexico Completion of Registration, cont’d • COFEPRIS registration is valid for five years. • Registrations are publically available, in the name of the MRHAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 27. The Medical Device Regulatory Process in Mexico Additional Considerations • Certain products also require Import Permits after the device approval, such as: – Radiation Equipment – Animal Tissue products – Implantable DevicesAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 28. The Medical Device Regulatory Process in Mexico Additional Considerations, cont’d • Import permits are issued either: – For a set time period, or – For a set number of productsAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 29. The Medical Device Regulatory Process in Mexico Adding Distributors to the Registration • Manufacturers must identify distribution partners within Mexico and prepare Letters of Representation for these partnerships – The letters must be provided in Spanish; or if provided in any language other than Spanish, it must be translated by a certified translator – The letters must also be notarized and apostilled/legalized – Distributors must have: • Aviso de Funcionamiento (Operating License) • Aviso de Responsable Sanitario (License of the Responsible Person) – Mexico Registration Holder must submit the distributor addition requestAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 30. The Medical Device Regulatory Process in Mexico Transferring Registrations • Original MRH must provide a signed letter, notarized in Mexico, agreeing to transfer the approval. • Original MRH must also provide a copy of the full dossier submitted for the registration, plus any amendments made after the approval. • New MRH submits Administrative application Form and provides the above supporting information.AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 31. The Medical Device Regulatory Process in Mexico Ongoing Compliance in Mexico, cont’d • Device registration renewals occur every five years – Must be submitted 150 calendar days before the expiration • New models require a technical modification to the registration • Other changes also require a modification, such as to the manufacturing site • Draft Guidance released for vigilance activitiesAFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  • 32. The Medical Device Regulatory Process in Mexico Thank you for your time! Additional Resources Mexico Regulatory Process Chart: http://www.emergogroup.com/files/medical-device-regulatory-process-mexico.pdf Mexico Medical Device Regulations: http://www.emergogroup.com/resources/regulations-mexico For more information, please contact: Ann Marie Boullie EMERGO GROUP | Director of Business Development annmarie@emergogroup.com +1.512.327.9997AFRICA | ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com