Sanitary Registry of Medical Device

In order to market a medical device in Mexico, it is necessary to have a sanitary authorization for the product, the name of such authorization is called SANITARY REGISTRATION.

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1. REGISTRATION OF ESTABLISHMENT

Notice of Operation and Health Responsible

  • To begin the regulatory process in Mexico, you must register the establishment that will appear in the product's sanitary registry, this company will acquire all legal responsibility for the product.

  • The company requesting this procedure must be legally constituted in Mexico.
    This procedure accredits a PLACE

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2. PRODUCT NOTIFICATION

Health Register

  • To be able to market a health product, it is necessary to have a document that authorizes the sale and free distribution of the product in national territory.

  • This document endorses the PRODUCT .

  • To obtain the sanitary registration, it is necessary to comply with legal, administrative and technical requirements.

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3. ACTIVITIES

Import, Advertising

  • Once you have obtained the sanitary registration, you require authorization to carry out activities such as importation and/or advertising.

  • This procedure allows the action of IMPORTING OR ADVERTISING the product.

  • In order to obtain the import permit, it is necessary to have the sanitary registry.

PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU

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SUBSIDIARY IN MEXICO
  • Registration with a subsidiary owner

  • Managing your time

ADVANTAGE

DISADVANTAGES

  • investment required

  • Requires time to carry out procedures for the legal constitution of the company

  • It requires a physical place where the legal address of the establishment is declared.

  • You need to develop a Quality Management System.

  • Requires notifying a drug or technovigilance unit

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HOLDER (STRATEGIC COMPANY)
  • Establishment has already been notified before COFEPRIS.

  • Avoid wasting time to carry out the legal constitution of the company in Mexico.

  • It already has a health professional who will act as the product's health manager.

  • It has a Pharmaco and Technovigilance unit.

ADVANTAGE

DISADVANTAGES

  • Registration with a subsidiary owner

  • Managing your time

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AGREEMENT WITH DISTRIBUTORS

Administrative  

  • You can have 1 or multiple distributors.

ADVANTAGE

DISADVANTAGES

  • Problems with distributors due to disagreement in the commission agreement.

  • Favorable contracts for distributors.

  • They can violate confidentiality agreement and make use of industrial designs.

FREQUENT QUESTIONS

How long does it take to obtain the sanitary registration of a medical device in Mexico? Currently, the times before COFEPRIS have been prolonged due to the lag derived from the health contingency, with the most encouraging scenario being 10 months once the process has been submitted to COFEPRIS. Do not believe in those who promise you less time. Is a lie.

What is the validity of the health registration? 5 years, once that period has elapsed, an extension must be requested to extend the validity of the sanitary registration for another 5 years.

What documents must be submitted to request the sanitary registration? It will depend on the characteristics and classification depending on the level of risk of the product, which may be: 1. Legal Documents a) Certificate of Good Manufacturing Practices or ISO 13485 b) Certificate of Free Sale c) Letter of Representation 2. Documents proving product quality a) Quali-quantitative formula (if applicable) b) Analytical certificate c) Laboratory tests d) Manufacturing Process Flow Chart e) Sterilization f) Stability g) Biocompatibility h) Clinical studies i) Others

If in the future I wish to make any changes to the conditions of the sanitary registration of my product, can I make changes? Yes, it is possible to make several changes to the sanitary registry such as: 1. Assignment of rights 2. Presentations 3. Distributors 4. Importers 5. Expiration 6. ...

How many distributors and/or importers can I place in the sanitary registry? As many as you want, as long as each of them has its operating notice.

How to know the classification of my medical device? There are several alternatives: 1. Consultation with COFEPRIS (Disadvantage takes too long) 2. REGULATE performs the analysis based on regulation, technical product information and ex

Who will be in charge of supporting me in the process of obtaining the health registration? A group of specialists in medical device regulatory affairs will be in charge. Pharmaceutical chemists who have worked within COFEPRIS and/or Authorized Third Parties. We have reviewed around 500 files with more than 95% success.

Does REGULATE have experience in the regulatory process for obtaining health registrations? If REGULATE MÉXICO has been in the market for health supplies (drugs, medical devices and herbal remedies) for several years, as well as with products (cosmetics, food supplements, non-alcoholic beverages and food)