how to obtain medical device approval 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 compliance



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 days



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, approval



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 registrar



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 approval



Equivalency Agreement: Non-Eligible Companies

UNIVERIX TAPVS NYCE

Class I: 30,000 MX Class I: $50,000 MX Class I: $35,000 MX

Class II: $48,000 MX



Class III: $70,000 MX



•Standard Registration Process oReview direct by COFEPRIS, or oThird Party Reviewer



Mexico’s Classification System

Class I Class Ia Class II Class III

Level of risk to patient/user



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 products



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 COFEPRIS



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.




Examples of Class Ia Devices:

•Cotton, dressings, gauze, band-aids

•Optical and surgical microscopes

•Motion exercisers

•Collars, splints, immobilizers




Examples of Deregulated Products:

•Hospital beds

•Stand-alone software

•Stretchers, walkers

•Scales



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)



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 renewal



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 use



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 use



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 use



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)



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 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)



How to Prepare the Application 2. Complete Applicable COFEPRIS Form



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.pdf

http://www.cofepris.gob.mx/MJ/Documents/Normas/137ssa1.pdf�



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 off



Completion of Registration • Upon completion of its review of your device, COFEPRIS will issue a

certificate.



Completion of Registration, cont’d • COFEPRIS registration is valid for five years. • Registrations are publically available, in the name of the MRH



Additional Considerations • Certain products also require Import Permits after the device

approval, such as: – Radiation Equipment – Animal Tissue products – Implantable Devices



Additional Considerations, cont’d • Import permits are issued either:

– For a set time period, or – For a set number of products



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 request



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.



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 activities

http://dof.gob.mx/nota_detalle.php?codigo=5230373&fecha=19/01/2012�



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 [email protected] +1.512.327.9997

http://www.emergogroup.com/files/medical-device-regulatory-process-mexico.pdf�

http://www.emergogroup.com/resources/regulations-mexico�



how to obtain medical device approval in mexico

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