- Details
- Written by: Editor
- Hits: 245
We have talked about the documentary requirements for the application for the Sanitary Authorization (Marketing Authorization) of a Medical Device (MD), however, it is important that you also know that in order to be the Holder of the Sanitary Authorization, prior to the application for the Sanitary Authorization, you must comply with the following requirements in accordance with Article 181 of the Health Supplies Regulation (RIS) and the Pharmacopoeia of the United Mexican States (FEUM) Supplement for MDs:
Article 181 of the RIS states the following:
To be a holder of the Sanitary Authorization of the Supplies referred to in Chapter IX, of the Second Title of this Regulation, it is required to have a Notice of Operation of factory or production laboratory, warehouse of deposit or distribution or conditioning established in the national territory.
And to which Chapter IX of the Second Title of these Regulations refers: this section is exclusively focused on medical equipment, prosthesis, orthesis, functional aids, diagnostic agents, dental supplies, surgical and healing material, hygienic products and other devices for medical use, generally known as Medical Devices.
Therefore, in accordance with the provisions of Article 181 of the RIS, in order to be the holder of the Sanitary Authorization of a MD, it is required to have a Notice of Operation with the following particularities according to the type of establishment you have:
- If you are a Factory or Production Laboratory established in Mexico you require:
-
- Notice of Operation of Medical Devices or Herbal Remedies Factory.
- If you are a warehouse or distribution or conditioning warehouse established in Mexico you require:
-
- Notice of Operation of Warehouse and/or Distribution of Medical Devices or Herbal Remedies or Uncontrolled Medicine or Raw Materials for Uncontrolled Medicine).
Additionally, the FEUM supplement indicates that in order to become a Holder it is required to:
- Submit the application in the official format, adding the corresponding fee payment according to the classification based on the sanitary risk of the product according to the Federal Law of Payment of Fees.
- Submit a copy of the Notice of Sanitary Responsible.
- In the case of MD that use radiation sources, in addition to the above, submit a copy of the corresponding license issued by the Ministry of Energy (National Commission for Nuclear Safety and Safeguards).
- As well as the file with the scientific and technical information describing the characteristics of the MD and demonstrating the safety and efficacy of the same, as well as the corresponding legal documentation (Art. 179 and 180 of the RIS for details on this topic visit our blog https://bit.ly/3ENEozL).
So if you are considering to become a holder of the Sanitary Authorization of a MD, remember that you must first register a Notice of Operation established in the national territory before the COFEPRIS and if you need help in carrying out this procedure, contact us and we can help you.
Do not miss our next blog topic, where we will be sharing information to continue learning about relevant topics on Health Regulation.
Write comment (0 Comments)- Details
- Written by: Editor
- Hits: 242
Medicines are one of the most used therapeutic tools to treat diseases in the population.
Given the importance of medicines in the health of the population, it is very important to know what types of medicines exist, the definition of each of them and what it is legal basis.
In the Ley General de Salud and in the Reglamento de Insumos para la Salud, we can find the definition of the types of medicines, as shown below:
Biotechnology medicine: Any substance that has been produced by molecular biotechnology, that has a therapeutic, preventive or rehabilitative effect, that is presented in pharmaceutical form, that is identified as such by its pharmacological activity and physical, chemical and biological properties.
Drugs produced by chemical synthesis: Any substance or mixture of substances of natural or synthetic origin that has therapeutic, preventive or rehabilitative effect, which is presented in pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics, and is registered in the Pharmacopoeia of the United Mexican States for allopathic medicines.
Vitamin Medicine: The product that in its composition contains only vitamins or minerals such as mono or polypharmaceuticals, alone or in association, indicated to prevent or treat ailments due to their insufficiencies, whose presentation is in pharmaceutical form.
Herbal Medicine: Products made with plant material or any derivative of it, whose main ingredient is the aerial or underground part of a plant or extracts and tinctures, as well as juices, resins, fatty and essential oils, presented in pharmaceutical form, whose efficacy therapeutic and safety has been scientifically confirmed in the national or international literature.
Homeopathic Medicine: Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect and that is prepared in accordance with the manufacturing procedures described in the Homeopathic Pharmacopoeia of the United Mexican States, in those of other countries or other sources of national and international scientific information.
Orphan Drugs: Medications intended for the prevention, diagnosis or treatment of rare diseases, which have a prevalence of no more than 5 people per 10,000 inhabitants.
Knowing what type of medicine our product is also helps us define the technical and legal documentation that we must present to the Sanitary Authority (COFEPRIS) to obtain the Sanitary Registry.
Don't miss our next blog topic as we continue to provide you with information to continue learning more about medications.
Write comment (0 Comments)- Details
- Written by: Editor
- Hits: 388
In order to market a Medical Device (MD) in Mexico, it is required to have a Sanitary Register issued by the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS).
But what is a Sanitary Register? A sanitary register is a sanitary authorization, that is, it is the administrative act by which the competent sanitary authority (COFEPRIS) allows a public or private person to carry out activities related to human health.
Now that you know what a Sanitary Register is, it is very important that you know articles 179 and 180 of the Health Supplies Regulation (RIS) which describe the documentary requirements that must be submitted to COFEPRIS to obtain the Sanitary Register of the MD's.
The following is a description of the documents indicated in the two aforementioned articles for MD's of National and Foreign Manufacture.
Article 179. - National Manufacturing:
a) Application in Official Format.
I. The scientific and technical information to demonstrate that the health supplies meets the characteristics of safety and efficacy;
II. The Label project in Spanish language, under the terms of the corresponding Standard;
III. The instructions, if applicable, for its use or operation manual in Spanish language;
IV. The description of the manufacturing process that is carried out to obtain the product;
V. The description of the structure, materials, parts and functions, in the case of medical equipment;
VI. The certificate of good manufacturing practices;
VII. The laboratory tests to verify the specifications of the health supplies;
VIII. Bibliographic references; and
IX. Others established by the Secretariat in the corresponding Standards.
Article 180.- In addition to the above documents, the following must be included for Foreign Manufacturing:
I. The certificate of free sale or equivalent, issued by the sanitary authority of the country of origin;
II. The manufacturer's letter of representation, if the product is not manufactured by the parent company or factory or laboratory that requests the registration in Mexico;
III. The certificate of good manufacturing practices issued by the sanitary authority of the country of origin, and
IV. The original certificate of analysis issued by the company that manufactures the product, with the letterhead of its corporate name and signed by the responsible chemists of the foreign company.
It should be noted that the aforementioned documentary requirements must demonstrate the quality, safety and functionality of the MD´s, since this will dependo on this whether or not the Sanitary Register is granted and thus ensure their commercialization in the national territory.
Currently, the request for a new Sanitary Register can be made in two ways: in person (at the windows of the Integral Service Center of the COFEPRIS) and electronically (electronic procedures page of the COFEPRIS).
If you are about to request the Sanitary Register of a MD and you have doubts about any of the requirements mentioned above, contact us at the number 55 6167 7092, we can help you put together your dossier of MD Class I Low Risk, Class I, II and III with the support of our experience, quality and confidence in obtaining your Sanitary Register (Sanitary Authorizations).
Write comment (0 Comments)