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ELANBiz Infocard:
Medical Devices
1Prepared by the ELANBiz Expert in México. Last update August 2017 For additional information, use our service Ask the Expert
This Infocard provides information about the access requirements for medical devices to Mexico
EU medical devices can be imported into Mexico duty free. However, it is important to establish their tariff code in order to determine other taxes which may have to be paid (VAT), as well as the specific requirements that must be met, such as the Import Sanitary Permit, the Sanitary Registration or the Mexican Official Standards, of mandatory compliance for the commercialization of these products in Mexico.
Description of the sector
The Mexican General Health Law classifies medical devices into six families based on their function and purpose. The six families of medical devices are:
Medical equipment: Appliances, accessories and instruments for medical use, apparatus, accessories and equipment for specific use, intended for medical and surgical care or screening and diagnostic procedures, treatment and rehabilitation of patients, as well as those intended for biomedical research activities.
Prosthetics, orthotics and functional aids: devices intended to replace or complement one function, an organ or body tissue.
Diagnostic agents: all the medical supplies including antigens, antibodies, calibrators, testers, reagents, reagent kits, culture and contrast media and any other which may be used as an aid in other clinical and para clinical procedures.
Dental supplies: Substances or materials used for dental health care.
Surgical materials: devices or materials with or without added antiseptics or germicides used in surgical practice or in continuity solution treatments, skin lesions and annexes.
Hygiene products: Materials and substances which are applied on the surface of the skin or body cavities and have pharmacological or preventive action.
1“Content information provided in this document, is of general nature only. For more detailed information, events and commercial trade offers as well as commercial business contacts, please contact the Commercial Offices on the member States, the European trade organizations and bilateral chambers of commerce.”
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According to the Mexican Tariff Information System via Internet (known in Spanish as SIAVI), the medical devices sector to which this Infocard refers includes the following tariff headings:
Name of product Tariff code
Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes.
3005
Preparations and pharmaceutical articles as referred in a Note
4 of the chapter. 3006
Medical, surgical, dental or veterinary instruments or devices, including those of scintigraphy and the rest of electromedical equipment as well as the apparatus and equipment for vision tests.
9018
Mechanotherapy apparatus; massage equipment;
psychological aptitude-testing apparatus; ozone, oxygen aerosol therapy apparatus; respiratory resuscitation apparatus and other respiratory therapy apparatus.
9019
The rest of breathing apparatus and old masks, except for the protective masks without mechanism nor filtering element, removable.
9020
Orthopaedic articles and equipment, including medical surgical girdles, bandages and crutches; braces, splints and other articles and apparatus for fractures; prosthetic articles and devices; hearing aids and the rest of apparatus which person carries him or herself or implanted to him or herself to compensate a defect or disability.
9021
X-ray equipment, apparatus based on the use alpha, beta or gamma radiations including for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and the rest of the X-ray generating devices, voltage generators, command consoles, screens, tables, chairs and similar supports for testing and treatment.
9022
Medical, surgical, dental or veterinary furniture (for example:
operating or examination tables, beds with mechanism for clinical use, dental chairs); hairdressing chairs and similar chairs, with lifting and orienting devices; parts of these articles
9402
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Taxes and tariffs
The Integrated Information System of Foreign Trade (known in Spanish as SIICEX) provides information on the tariff taxes applied to any product up to the 8-digit tariff line.
Medical devices of EU origin are exempt from customs duties under the free trade agreement between the European Union and Mexico (known in Spanish as TLUE).
Value - Added Tax: 16%
Import requirements
For the importation of medical devices, it is necessary to comply with the following requirements:
Sanitary Import Permit, Sanitary Registration and the applicable Mexican Official Standards of the sector.
Sanitary Import Permit of medical devices
This is a permit issued by the Health Secretary through the Federal Commission for the Protection against Health Risks (known in Spanish as COFEPRIS).
There are various modalities of Sanitary Import Permits for medical devices. The most common modality for companies engaged in sales of medical devices is the “Sanitary Import Permit of medical devices which also requires Sanitary Registration”. To complete this procedure the importing company must submit the following documents:
Authorisation format, (known in Spanish as Formato de Autorizaciones, Certificados y Visitas), correctly filled out.
Copy of Sanitary Licence or operation notification from the corresponding business category.
Copy of the Sanitary Registration and its corresponding amendments, including a copy of its hologram labels.
Notification copy of sanitary responsible person of health services establishment.
Fees payments (original and two copies).
o Regarding the Fees payments, depends on type of register and fees can be consulted on the following link:
http://www.cofepris.gob.mx/TyS/Paginas/Pago-de-Derechos.aspx
o It is important to consider that the fees are generally updated in the beginning of each year and besides being published on the abovementioned link also it appears on Official Journal of the Federation (known in Spanish as DOF)
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For the following modalities of Import Permit it is not required to have sanitary registration;
Sanitary Import Licence without Sanitary Registration for personal use.
Sanitary Import Licence without Sanitary Registration for medical research involving human beings.
Sanitary Import Licence without Sanitary Registration for donation.
- Application processing time: 40 working days - Validity of the permit: 180 calendar days
- Where to apply: in person in the office of COFEPRIS or through the Single Window Facility for Foreign Trade.
1. Sanitary Registration
The Sanitary Registration is issued by (COFEPRIS). It is worth mentioning that a Sanitary Registration is not required for a certain medical devices published by COFEPRIS http://www.cofepris.gob.mx/AS/Documents/RegistroSanitarioMedicamentos/no_registran.pdf The requirements and processing of the Sanitary Registration may vary based on a series of modalities listed by COFEPRIS:
Application for Sanitary Registration of Medical Devices COFEPRIS-04-001-A Modality A.- Domestically manufactured products COFEPRIS-04-001-B Modality B.- Imported products (Foreign manufacture)
COFEPRIS-04-001-C Modality C.- Domestically manufactured products which are manufactured by other establishments
COFEPRIS-04-001-D Modality D.-Products with Class I FDA Register (USA and Canada Equivalence Agreement)
COFEPRIS-04-001-E Modality E Products with Class II and III FDA Register (USA and Canada Equivalence Agreement)
COFEPRIS-04-001-F Modality F.- Products with Class II, III and IV Register IV HEALTH CANADA (USA and Canada Equivalence Agreement)
COFEPRIS-04-001-G Modality G.- Controlled and designated medical devices (class II criterion established conformity) with issued certificate by one certification body registered before MHLW of Japan (Japan Equivalence Agreement)
COFEPRIS-04-001-H Modality H.- Class II medical devices (without class II criterion established conformity), III and IV with letter of approval issued by MHLW of Japan (Japan Equivalence Agreement)
COFEPRIS-04-001-I Modality I.- Domestically manufactured products considered as being low risk
COFEPRIS-04-001-J Modality J.- Imported products (Foreign manufacture) considered as being low risk
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COFEPRIS-04-001-K Modality K.- Domestically manufactured products considered as being low risk which are manufactured by other establishments
In addition to identifying the relevant modality for your product, it is necessary to determine its Class classification, according to its level of risk. This will determine which specific requirements must be met and the fees to be paid. The Class classification is established in article 83 of Regulation on Health Items
Class I: Defined as those that “are very well known in the medical field, with proven effectiveness and safety, and that generally are not introduced into the human body.”
Class II: Defined as “well known in the medical field, but may have a variation in the raw materials of which they are made, or different component composition or concentration, and that are introduced into and kept in the human body for less than thirty days.”
Class III: Defined as “new products or products recently approved in the medical field, or products that are introduced and kept in the human body for more than thirty days.”
To be certain about the classification of your product according to risk level, we recommend you to make a technical enquiry before the COFEPRIS.
That said, in general terms the requirements for obtaining Sanitary Registration are:
The scientific and technical information describing the characteristics of the device and demonstration of its safety and efficacy.
A copy of the label, in Spanish, with information as required by Official.
Mexican Norms Instructions for the device’s use or operation manual, in Spanish.
Description of manufacturing process.
For medical equipment, a description of the product’s structure, materials, parts, and functions.
Certificate of Good Manufacturing Practices (GMP).
Laboratory test results verifying the product’s specifications.
Bibliographic references.
In the case of medical devices that use radiation sources, a copy of the license issued by the Mexican Energy Secretariat (National Nuclear Safety Commission).
Technical and scientific information to demonstrate that items meet safety and efficacy features.
Certificate of Free Sale (or Certificate for Foreign Government) issued by the authority of the country of origin, translated into Spanish.
Certificate of Good Manufacturing Practice in force issued by the health authority country of origin or equivalent document issued by the body authorized by the country of origin, translated into Spanish.
Original or certified copy of the original letter of representation issued by the manufacturer, if the product is not manufactured by the parent company, subsidiary or
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affiliate of the registrant in Mexico, authenticated that the legal procedure that exists in the country of origin, translated into Spanish.
Manufacturer’s representation letter, certified by the legal procedures which exist in the country of origin, in Spanish or other language, with its respective translation to Spanish made by an official translator. If the product is not manufactured by the parent company, factory or laboratory which is applying for Sanitary Registration in Mexico it is necessary to present Certificate of good manufacturing practices issued by the sanitary authority in the country of origin.
Copy of analysis certificate issued by the company which manufactured the product, on company’s letterhead and duly signed by quality assurance officer.
Fees payment
o The specific fee depends on the type of Registration and can be consulted on the following link: http://www.cofepris.gob.mx/TyS/Paginas/Pago-de-Derechos.aspx o It is important to consider that the fees are generally updated in the beginning of
each year
The documents which an importing company must have are:
o Copy of operation notification from establishments of medical supplies.
o Notification copy of sanitary responsible person of health services establishment NOTE: All documents accompanying applications must be submitted in Spanish, or if not, their translation into Spanish supported by the signature of the sanitary responsible person must be attached to them. Documents issued by authorities of other countries must be apostilled or legalized and translated by official translator.
- Application processing time: Between 30 to 45 working days but it can be up to 1 year depending on the product category
- Validity of permit: 5 years
- Where to apply: in person in the office of COFEPRIS.
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2. Mexican Official Standard (NOMs)
The tariff code will determine if the product to be imported must comply with any Mexican Official Standards (NOM), that establish the sanitary and technical compulsory specifications for the products commercialised in Mexico.
The various standards applicable to medical devices are available in the following link:
http://www.cenetec.salud.gob.mx/contenidos/biomedica/normas_equipo.html Here, you can obtain access to the industry standards by selecting one of the four groups in which they are divided:
equipment, installations, operation and safety.
You can also identify the relevant standards in the Mexican Standards Catalogue published by the Secretary of Economy.
Recommendations for EU exporters
a) COFEPRIS published a list of products intended for medical use that are not considered medical devices, for example: hospital beds, we suggest to review this information in the following link.
b) In the case of importation of medical devices for purposes of medical research, the requirements for the importation are different.
c) The imported products may be labelled after customs release and before sale to general public, provided that the tariff code does NOT indicate otherwise.
d) For the Sanitary Registration application:
o We recommend you to verify the product category, as this will determine not only the duties to be paid for the application, but also the processing time and the specific information that should be provided in the required documents.
o Consider that the products can only be imported by a Registration holder and by the importing company appointed by the holder and stated in the Register.
o Only the products individually specified (by name, code) in the Register may be imported.
o Labels must include the necessary product information and must be consistent with the Sanitary Registration.
o There is an option than may reduce considerably the processing time: the documents required should be submitted first to an entity authorised by COFEPRIS. This entity will prepare an “opinion” on the information provided, which should then be included in the Sanitary Registration application submitted to COFEPRIS. Consider, however, that this option does not assure that you will receive a favourable “opinion” from the authorized entity.
o Take into account that the Mexican regulations are only published in Spanish.
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e) In order to verify the specific requirements applicable to your product, we recommend that you use our service “Ask The Expert”
Frequent Errors
a) The denomination or presentation of the product on the label differs from the one specified in the Sanitary Registration. Take into account that even slight differences are not considered typing errors.
b) The address of the manufacturer or distributor on the label is different from the one that is indicated in the Sanitary Registration.
c) The imported products are sent to a custom different from the one authorised in Sanitary Import Licence.
d) The amount of goods or devices authorised in the Sanitary Import Licence is exceeded.
Useful links
a) General Health Law:
http://www.salud.gob.mx/unidades/cdi/legis/lgs/LEY_GENERAL_DE_SALUD.pdf b) Regulation on Health Items:
http://www.cofepris.gob.mx/MJ/Paginas/Reglamentos.aspx
c) Format of the Health Department for the Protection of Health Risks:
http://www.dof.gob.mx/nota_detalle.php?codigo=5465059&fecha=12/12/2016
On this link, you can find different types and modalities of Sanitary Registration and Import Sanitary Licence.
d) Decision establishing the classification and codification of goods subject to sanitary
regulation on the part of the Health Department.
http://www.cofepris.gob.mx/MJ/Paginas/Acuerdos/AcuerdosCOFEPRIS.aspx e) General Taxation tariffs regarding Imports and Exports:
f) http://www.siicex-caaarem.org.mx g) Official Mexican Standards catalogue:
http://www.economia-noms.gob.mx/noms/consultasAction.do
h) List of products intended for medical use that do not require Sanitary Registration:
http://www.dof.gob.mx/nota_detalle.php?codigo=5376857&fecha=22/12/2014 i) Fees payments:
http://www.cofepris.gob.mx/TyS/Paginas/Pago-de-Derechos.aspx
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Disclaimer
The positions expressed are those of the authors and do not necessarily reflect the official opinion of the European Union. Neither the European Union nor any person acting on behalf of the European Union is responsible for the use which might be made of this information. Neither
the European Union nor the ELANBiz consortium members are responsible or may be held accountable for any loss suffered as a result of reliance upon the content of this Fact Sheet
