Author: jafet

On June 22^nd of this year an agreement was published, which modifies the one published on January 28^th, 2020, on marketing authorization certificates through equivalence acknowledgement for authorized medications by the regulatory agencies, mentioned afterwards.

The most important modification is that in the agreement of June 22^nd, Medical Devices are now included, which were not on the first edition of the agreement. It also establishes the criteria and technical requirements needed to apply for the approval through equivalence acknowledgement.

Remember that ‘medical devices’ include all items mentioned on Chapter IX of the Regulation of Healthcare Products (RIS): medical equipment, prosthetics, orthotics, functional help, diagnostic agents (IVD), odontology products, surgical material, healing material, hygiene products, and other healthcare products.

It is important to differentiate this agreement from the ones published in 2010 and 2012, since the requirements of marketing authorization certificates through equivalence acknowledgement are totally different. Though, it may be confusing because some of the regulatory agencies are the same and both agreements mention equivalence and acknowledgement. However, they are completely different topics.

The agencies acknowledged on this agreement for the marketing authorization certificate in Mexico are:

Marketing authorization certificates protected by this agreement:

• To apply for marketing authorization certificates of medical devices, it is required to apply in writing
• Dossiers can be submitted in English or Spanish
• Attention times for applications will be half than the established period
• The established periods mentioned on Art. 179 in RIS are:
  • Class I – 30 days with affirmative ficta
  • Class II – 35 days
  • Class III – 60 days
  • With pre-verification from authorized third parties – 15 days
• So, the longest period will be 30 days, which should be confirmed in practice.

There are some important considerations mentioned in the publication form January 28, 2020, that will not be affected by the last publication:

It will be reason to reject the application if the product is bulletined by the WHO or by any regulatory agency, or when the safety profile is not acceptable, or the risk-benefit ratio is not favorable.

Period: 30 workdays with negative ficta, one third (10 days) for administration requirement deficiency letters, two thirds (20 days) for technical requirement deficiency letters. As in any other procedure, once a deficiency letter is issued, the timeline will be suspended and resumed the next workday after an answer has been submitted.

The marketing authorization certificate holders that obtain the certificate through this ordinance are not exempt of complying with other requirements to maintain the approval, or be subject to sanitary monitoring and control. It remains an obligation to make registration renewals and variations, as with any other marketing authorization approval obtained through any other path.

If the registration in the country of origin is revoked, Cofepris must be informed within 5 workdays, as well as any changes in the safety profile or risk-benefit ratio.

The requirements to obtain the registration by this path will be published soon in this same site, please subscribe to our newsletter to be informed.

Traditionally our MoH does not comply with the official times of registration, based on our experience (pre-COVID), we can give you an estimate from submission, of a 100% completed dossier, in Spanish, just as Cofepris expects it.

Traditional path of registration directly to Cofepris (pre-COVID timing):

• New registration: Class IA: 1-3 months.
• New registration: Class I and II: 6-10 months
• New registration: Class III: 10-18 months

If the dossier is not complete, or if there is a doubt about anything, Cofepris will request additional information in a deficiency letter, called “prevention”. Cofepris provides a deathline to answer that prevention, if the information is not submitted complete and on time, the application will be cancelled, so always consider that the more complete the dossier is, the faster it will be approved, as the issuing of a prevention delays the registration time in about 4 months, plus the time you take to get the information and answer.

This is why is so important that your consultant have experience in fulfilling complete and accurate applications, so your products will be approved faster. For more information contact us.

We will be discussing in the future the updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.

UNOPS fast track registrations.

Equivalence procedures for medical devices.

On November 18^th, 2020, Cofepris published very aggressive timelines: 5 working days for registration approval for those new registrations submitted via equivalence procedures.

However, we cannot guarantee that our authorities will actually comply this timing. This approval is only for bids and government sales (UNOPS biding), and it is not applicable for private sales. If you want to sale in private market you can use or not equivalence procedures, but the registration time will be the regular one.

There are 3 recognized equivalence procedures:

• US FDA (they require a 510k + EIR)
• Health Canada
• Japan

We will be discussing in the future the specific requirements for each equivalence procedure, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.

For more information about obtaining your registration in Mexico with or without equivalence procedures contact us.

Classes: In Mexico there are 4 classes for Medical devices:

• IA – Low risk – there is a specific list and the device must be listed to be in this classification.
• I – Mainly external products – not sterile, per example: hygienic products
• II – Sterile or invasive that stays in the body or in contact with the patient for less than 30 days
• III – Invasive that stays in the body or in contact with the patient for more than 30 days. Includes all implants. High risk products.

Classification/grouping is according to Mexican criteria and ruling, despite the classification in the country of origin.

If you have any doubt please contact us and we will help you to determine the classification for your medical devices.

Grouping criteria:

In Mexico, as in many countries, you can register a family of products together, if they comply with the grouping criteria from Cofepris, which a Grosso modo are the following.

The products to be grouped must have:

• The same manufacturer
• Same class (according to Mexican classification)
• Same intention of use (final indication) and technology (new technology is new registration)
• Same materials or formulation (same active ingredients)
• Consider that all that can be sold apart must be registered apart (p. e. consumables, if they will be imported independently, they will need a separate registration)

Final criteria are always from Cofepris. If you have any doubts about how to group your product please contact us and we will be happy to help.

We will be discussing in the future the specific requirements for registration, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.

If you are a medical devices manufacturer and are interested in selling / importing your medical devices to Mexico, then you want to continue reading.

Medical devices are described under the General Health Law in Mexico and includes the following products:

– Medical equipment

– Prothesis, orthosis and functional aids

– Reactives, diagnostic agents and IVDs

– Odonthological supplies

– Surgical and healing supplies (medical materials)

– Hygienical products

Medical devices require a registration (Marketing authorization) that is valid for 5 years and can be renewed, and sometimes requires importation permit after registration for each importation.

In order to register a medical device in Mexico, you need to comply the following in order to be eligible to be a registration holder in Mexico, and make a registration application:

1. You need to be a legally established company in Mexico with a legal representative with permanent residence in Mexico
2. You need to have an operational warehouse with a quality system (SOPs) – notified in MoH, The Mexican Pharmacopeia describes the infrastructure you need for a health supplies warehouse, and basically it needs to be an independent warehouse from other companies and different classification of products.
3. Also you need a Sanitary responsible also called technical director that can be a Pharmacist, biomedical engineer or chemist – notified in MoH
4. Finally you need to have a technovigilance unit with a technovigilance responsible – notified in MoH

If you are not ready to develop your own infrastructure, Rafconsulting can act as your Mexican Registration Holder (MRH) for your registrations in Mexico. Please contact us for more information.

Once you comply with the company’s requirements to register medical devices, then you can proceed to the registration application for your medical device:

The general requirements for registration are the following:

1. Free sale certificate (FSC) issued by the Health Authority from the Country of Origin or clinical trials performed in Mexico. Legalized original.
2. GMP certificate or ISO 13485 for every facility involved in the process (Manufacturing, sterilization, packaging, etc.) Legalized original
3. Representation letters or Power of attorney naming holder and distributors (issued by manufacturer) Legalized original.
4. Technical dossier: must document every step from design, materials, manufacturing, finished product, stabilities, performance, etc. You need to demonstate quality, safety and efficacy, and detailed evidence is required.
5. Original Certificate of Analysis or Conformance.
6. Everything must be submitted in Spanish and organized according to Cofepris Criteria.

In Rafconsulting we will be happy to help you determine the requirements for your specific product, we can help you with all that you need to register, import and sale your medical devices in Mexico, please contact us for more information.

We will be discussing in the future the specific requirements for registrations, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.