AUTHORIZED AGENT - HOLDER

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Medical device registration in Mexico is a procedure that may end up talking up to a year for each proceeding filed before COFEPRIS, which delays the legitimate marketing of products, for which COVELAR offers solutions for your expansion plans in shorter periods of time.

Selling medical devices in The Americas represents around 46% of total global sales, being Mexico, along with USA and Brazil, one of the main entry points to the market of The Americas.

Our offer for foreign companies is mainly based in a platform for the expansion of their brands and products in Mexican territory, assisting in their products’ registration processes, since we have the ability to hold the appointment of health register to then cede it through a subsidiary of the manufacturer, or through the local distributor which authorizes the commercialization of their products in a legal way.

At our international clients request, we handle all legal procedures to the opening of subsidiaries in Mexico, procedure manuals for training sales and technical personnel, recruiting and ongoing training regarding the management of the sales process for client attracting and retention, product launch planning, product registration in hospitals, and implementing a techno-surveillance program to control registered products in force.

The main aim is to reduce expenses both in time and money to our clients, streamlining all proceedings so that as soon as the products are registered, a platform can be presented for them to decide whether they wish to invest by bringing their company to Mexico or initiating negotiations with a national medical trading company already established, to start with a sales plan that will come up as effective and immediate for all parties.

OPERATION NOTICE

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It’s the notification given to the health authority regarding the activities to be performed in an establishment, which may foresee a sanitary risk and, if necessary, the simultaneous notice of a health responsible for the required modality. As well as any modification of the general information or its retirement.

Among the services that COVELAR is able to offer in the aforementioned area, you can find:

• ✓ Registration of operation notice

• ✓ Notification of modification or retirement of the operation notice
•            ‣ Modification of the register holder information
•            ‣ Legal representative
•            ‣ Sanitary responsible
•            ‣ Authorized personnel

HEALTH MANAGER NOTICE

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The sanitary responsible is the legal form in charge of securing the identity, purity and safety of the products and processes performed in the establishment. It is therefore important to notify the authority about the identity of the person that holds such legal form within the establishment.

Our firm has the ability of offering the service of Sanitary Responsible of the establishment, along with the experience of intervening in quality assurance processes.

Some of the services that COVELAR offers are:

• ✓ Registration of sanitary responsible

• ✓ Modification or retirement of sanitary responsible

NEW HEALTH REGISTER

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According to chapter IX of the Regulation of Raw Materials for Health Products, in article 82 it is stipulated that medical equipment, prosthesis, orthosis, functional aids, diagnosis agents, materials for odontology use, surgical materials, healing materials, hygienic products and other medical use devices require health register for their production, sale and distribution.

To obtain a health register it is necessary to submit to COFEPRIS all legal, technical and scientific documentation that verifies the safety and effectiveness of the product in question.

In COVELAR we prepare Class I, II and III medical device registration files to obtain the health register according to the requirements and regulations established by COFEPRIS. That’s why we offer to our clients the following services for the obtaining of new health register:

• ✓ Advisory in proceedings to be presented before COFEPRIS

• ✓ Product classification

• ✓ Evaluation of legal, technical and scientific documentation to form the register file

• ✓ Technical translation from source language to Spanish

• ✓ Production and organization of register file

• ✓ Procedure management before COFEPRIS

MODIFICATION TO THE REGISTER CONDITIONS

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Once a health register is issued, modifications to the original registration terms which weren’t contemplated at the beginning of the process can be requested, so the modification may be required to the authority in order to update the information in the health register.

Among the modification that can be made to the register we can find, but are not limited to, the following:

• ✓ Administrative changes
•          ‣ Manufacturer or register holder name or address change

•          ‣ Incorporation of new licensed distributors

•          ‣ Transfer of rights

• ✓ Technical changes
•          ‣ Changes in the manufacturing process

•          ‣ New product presentations

RENEWAL OF HEALTH REGISTER (EXTENSION)

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If the client requires it, a renewal of a health register approaching delinquency can be requested to COFEPRIS.

To obtain the renewal of the health register the documentation required by the authority to concede such extension must be submitted properly and on time. In COVELAR we take care of scheduling previously required proceedings, thus preparing beforehand all the information and paperwork that is to be presented, as well as managing the procedure itself.

TECHNOVIGILANCE OR PHARMACOVIGILANCE UNIT

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With the aim of assuring the safety and effectiveness of medical devices commercialized in Mexico, it’s necessary for the establishment to have a techno-surveillance unit, which must keep track of every notified unfavorable event, and also conduct an investigation of such events and implementing preventing and corrective actions derived from the investigation, or mandated by the Health Department.

In COVELAR, we provide support to the companies for the setting up and proper operation of their health techno-surveillance units, and also for the arranging of the registration of the surveillance unit before the authority.

TECHNOVIGILANCE OR PHARMACOVIGILANCE REPORT

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As part of the requirements to request before COFEPRIS the renewal of a health register, it is necessary to submit properly and on time the technovigilance or pharmacovigilance report of the commercialization period of the product to be renewed.

COVELAR guides and supports our clients in the making of this report, we also handle all the information required to make this control document, essential to proceed with all the procedures required by COFEPRIS.

Some of the services we offer in regard to techno-surveillance are:

• ✓ Database management

• ✓ Product history

• ✓ Investigation of adverse reaction or event

• ✓ Implementation of preventive and corrective actions

PROCEDURE MANUALS

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As important as necessary to develop different departments, defining positions and their roles, there are manuals which capture the essence of the objectives of the company and how to reach them; in COVELAR we work hard to express each company’s management ideas to achieve it.

TRAINING SALES AND TECHNICAL PERSONNEL

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By knowing better than anyone the information of our medical devices, COVELAR can design a general training program covering the A-B-C of what personnel should have full command over, in the technical area, studies, instructions, publications, as well as the commercial area, strengths, opportunities, weaknesses and threats of the current market, in order to face competence in an effective way.

RECRUITING AND TRAINING OF THE SALES FORCE PERSONNEL

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One of the biggest challenges at industry level is the training of a successful sales team, many of those hired aren’t proficient in the techniques that will lead them to fulfill the expectations of their employers; in COVELAR we examine the candidates and provide a diagnose of each one of them to know which areas of opportunity to work individually to transform any weakness into strengths. We also offer a variety of choices in short length courses useful as a complement for continuing education and motivation of the sales force of your company. Of those, these are some:

• ✓ Task force management

• ✓ Sales fundamentals

• ✓ Sales techniques

• ✓ Sales force administration

• ✓ Post-sale strategy and client loyalty

• ✓ Sales projection

• ✓ Negotiating skills

• ✓ Problem solving and decision making

• ✓ Public relations

• ✓ Pricing strategy

• ✓ Consumer behavior

• ✓ Consumer psychology

• ✓ Costumer service

• ✓ E-Business

REGISTRATION MANAGEMENT IN PRIVATE HOSPITALS

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One of the most important procedures after the acquisition of the health register is processing the registration as a supplier before all of those hospitals with which is desired, said process may take time; COVELAR can counsel you and/or manage your processes prior to the launch of the product so everything’s ready to sell your medical devices as soon as possible.

PRODUCT LAUNCH

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As part of the pre-launch of your medical devices, it’s important to clearly define the objective or target market that is to be reached; in COVELAR we can guide you through the organization of your product launch event, from the choice of guests, mouth to mouth broadcasting of the event to both your target and your current clients, digital media campaign, setting up of Q & A section during the event — since the newer the device, the more questions it’ll generate, and you have to be up for the occasion —, e-mailing marketing, among others, so it’s a striking and interesting event for your guests.