You can also check our first update in this link.

1. Submissions to COFEPRIS and return of responses

The first regulatory change to mention is regarding the request and response process of priority requests at COFEPRIS. To avoid agglomerations in the main offices of COFEPRIS located in Mexico City (CIS), the commission implemented measures to keep receiving requests by using courier services such as FedEx, DHL, UPS among others. In general terms, any company requesting a procedure with COFEPRIS must send a prepaid shipping guide.

2. COFEPRIS Confirmed submission list

The process of reception and return of requests as previously described, caused a lack of traceability by users. All companies needed to wait for weeks for a response with the entry number assigned to each request only to confirm that request had been received correctly by COFEPRIS and finally be able to follow-up the response in COFEPRIS website. To solve this issue, COFEPRIS published a list of entry numbers updated periodically. In the above-mentioned list, the users can quickly find their tracking numbers assigned by courier and those numbers are related with its corresponding entry number for each request to follow up the response in the COFEPRIS website.

3. List of serological tests for detection of SARS CoV-2.

With the aim of protecting the health of the population from rapid tests for SARS CoV-2 clandestinely sold without a sanitary registration, COFEPRIS published a list of all rapid tests that have been authorized for its marketing. COFEPRIS updates this list once a new test has completed the temporary authorization process for this type of medical device.

4. Government direct purchases

In the last days with focus on guarantee the supply of health products, including medical devices. Legislators have promoted an amendment to a Law that would allow the Mexican Government making direct purchases abroad without requiring authorizations or tenders. If the amendment to this law is approved, the sector would be negatively affected since a large part of the income of several distributors of medical devices comes from sales to the Government.

Companies and professionals in the sector must monitor the changes mentioned above and those that may arise in the coming months.

Thanks for reading this article, if you have any question about this topic, feel free to contact us at contact@veraqueconsulting.com or check our guides.

The post Changes in the medical device market in Mexico resulting from the COVID-19 (part II) appeared first on Veraque.

During the COVID-19 health contingency, various economic activities have been altered. The medical device industry is not an exception. Therefore, in this article we summarize how this sector has been affected in the latest months and what measures the health authorities in Mexico have taken. We will focus on specific medical devices that have been affected by sanitary regulations.

Submission of requests to COFEPRIS

One relevant measure COFEPRIS has taken to face this outbreak is to publish a list of requests considered as a priority during the emergency. This list includes 186 types of requests. The foregoing means that the rest of the requests (non-priority) will present a delay (not reported), giving COFEPRIS the faculty to legally avoid timeline compliance on those products not related to the COVID-19. As expected, these actions have seriously affected the industry as any request for sanitary registration and other related procedures are treated as second priority if the procedures are not related with products for treatment and diagnosis of COVID-19. This measure will result in long evaluation times.

It is also important to mention that COFEPRIS partially closed its operations, ceasing to receive requests in person. Users now must send and receive their requests by ordinary mail or courier.

Approval for government purchase of products without sanitary registration.

It is worth mentioning that Mexican Government published an official document indicating that during the health emergency, the Ministry of Health (as part of the Government) would be the only organization empowered to import or buy products related to COVID-19 to be used in public hospitals (including: ventilators, masks, diagnostic tests, etc. ) without requesting sanitary registration or import permits from these products.

Although this initiative is suitable for providing health supplies more quickly around the country, it caused cases of corruption and it also generated complaints from the private industry.

It is worth mentioning that the above-mentioned official document has been misleadingly used to confuse buyers of acquiring COVID-19 related products without having a sanitary registration.

Diagnostic tests

Regarding diagnostic tests, COFEPRIS initially approved only molecular tests (PCR); however, the approval of serological screening tests (rapid tests) has been published recently. Another action has been to establish protocols to guarantee the effectiveness of the results of these COVID-19 diagnostic tests, issuing a list of products already approved for commercial use.

About the application of this tests in public hospitals, the Institute of Epidemiological Diagnosis and Reference (InDRE) has also contributed in carrying out molecular diagnostic tests. In this case InDRE is the organization who previously evaluated all diagnostic tests before a sanitary registration could be granted by COFEPRIS.

It is interesting to mention that before the COVID-19 pandemic only a few diagnostic tests were evaluated by INDRE (including those related to SDTs, such as HIV, Hepatitis).

As this is a new process, requiring more procedures (unlike other countries that have shortened the regulatory process), InDRE is currently overworked and there is not guaranteed to have an answer.

To help understanding the current approval process. Whoever interested in registering a diagnostic test for Covid-19 in Mexico should:

• Request an import permit to bring test samples to Mexico (in case they are not manufactured in Mexico).
• Provide samples to InDRE for evaluation. Such approval can be received within 1 month.
• Once InDRE approval has been received through COFEPRIS (by courier, as described above) and wait for a temporary approval document within the next 15 days. This means, COFEPRIS will “automatically” approve the product and meanwhile reviewing technical and legal documentation to issue a formal sanitary registration.

Medical ventilators

Ventilators are considered a Class II (risk classification) medical devices in Mexico. However, recently, universities, engineers and manufacturers have released free diagrams to develop devices known as Ambu-bag ventilators. This type of devices has created confusion in the sector since they are not properly a standard ventilator, but an automated Ambu-bag system. However, when if its purpose is clearly established as life support for patients who require subsequent intubation to a ventilator, this is an adequate alternative.

In Mexico, the regulatory process to make available medical ventilators was not eased (unlike other countries). COFEPRIS currently requires ventilators to be validated through CENAPRECE. Institution that was not previously related to any regulatory process in Mexico. Therefore, the process has been ambiguous and is focused on supporting those manufacturers that exclusively develop and manufacture ventilators (even before the COVID-19). When recieving a CENAPRECE approval, COFEPRIS will also grant a temporary approval document. The process is similar as with the diagnostic tests.

Face masks

There is an actual shortage of protective face masks, mainly KN95 or N95 for medical use.  This situation has led to the development of an informal economy based on manufacturing and distribution of non-regulated face masks made of manufacturers commonly focused in non-medical textile industries.

Is worth mentioning that in Mexico, protective masks for medical use are treated as Class I low risk medical devices and thus require a sanitary registration. This kind of products are considered as low risk devices requiring a simple registration process.

On the other hand, face masks not for medical use are not considered as medical devices and do not require any sanitary registration.

Protective face masks are an example of medical devices benefited by sanitary regulations in Mexico because this product is considered as a priority for approval and their regulatory registration is simple. However there is a challenge with the informal economy offering KN95 or N95 masks for medical use not filling quality and regulatory requirements (putting in a higher risk health professionals working with infected patients).

Surgical clothing

As with face masks for medical use, surgical clothing is considered a low-risk Class I medical device.

This kind of product is also benefited by the Mexican health regulation and it has been found in an informal market that sells products not compliant with the necessary requirements to protect health personnel (as in the case of masks).

Thermometers

These products are considered as Class II medical devices. Although they have been benefited by the Mexican health regulations, their approval process is more complex than low-risk Class I devices.

Likewise, we have noticed a significant offering through online platforms not declaring the sanitary registration.

Surgical gloves

About surgical gloves. Particularly the widely use nitrile or latex, are both considered as Class II medical devices.

These products have also been benefited by the Mexican sanitary regulations and we have noticed that this is one of the only  COVID-19 related products which the supply has not been affected due to national suppliers, because this was an already a solid industry in Mexico prior to the pandemic.

Disinfectants

The disinfectant products situation is controversial overall. Specifically, because there are many products commercialized as sanitizers (that do not destroy the virus), these products are not considered as medical devices.

However, disinfectants including ingredients, which are considered in the health regulations, have an ambiguity, since they are considered class I medical devices (as long as they are not intended for the final process of another medical device – such as autoclaves) and therefore they would be considered class II). However, we also find in the list of products that do not require sanitary registration, that disinfectants do not require a sanitary registration. This ambiguity has caused that they may or may not be sold with sanitary registration.

Conclusion

In this article we have reviewed that there are COVID-19 related medical devices that have benefited from the sanitary emergency and other devices have been affected (ventilators, diagnostic tests, among others).

Likewise, market behavior has been detected that tends to lack information or misleading data to take advantage and selling what seems to be safe. This is not an exclusive trait for Mexico, so we would like to invite all those involved in the industry to do their best to share reliable information for consumers, to deliver products for those who need it most.

For more information, check similar notes in our Guides.

In case you have any question or comment, please feel free to contact us at contact@veraqueconsulting.com

The post How the regulation for Medical Devices in Mexico changed due to COVID-19 appeared first on Veraque.

Introduction

Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS) –a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations.

In this article we highlight the main features you have to consider before submitting a request (here referred as “the dossier”) to COFEPRIS. We focus only on submissions related with medical devices.

Characteristics of the dossier

Considering that paper is used in the majority of the submissions. COFEPRIS has settled in this guide that all the dossiers presented in paper must have the following features:

1. Organized in separated files containing a maximum of 500 sheets each one.
2. Fastened with aluminum screw posts of adequate size to avoid loose sheets.
3. Use sheet protectors to save original documents that should not be perforated nor foliated (e.g. legal documents).
4. Identify each individual file with a printed label containing:
   1. Type of submission.
   2. Company name.
   3. Generic or distinctive name for the medical device.
   4. File number.
   5. Total files in the dossier.
5. The cover color in all files, depending on the type of request, must be:

Moreover, you should avoid:

1. Perforate relevant information and seals.
2. Use sheet protectors for ordinary documents.
3. Underline, cross out, hide or highlight text.
4. Use sheet separators, adhesive strips (Post-it) and blank sheets.

Finally, it is recomended:

1. Print sheets by both sides.
2. Write “No Text” in the back of one side printed sheets.

Sheets numbering

The specifications for numbering all sheets contained in the dossier are as follow:

• Number all pages at the upper-right corner in the front side.
• Use a numbering machine with color and size that allows easy identification.
• Start by numbering the last page of the dossier.
• Include single copies of all legal documents and number those duplicates.
• Cancel wrong numbers with diagonal lines.

To be avoided, when numbering sheets:

• Use handwriting for numbering sheets.
• Use correction fluid or labels to fix numbering mistakes.

Do not number the following documents

• Printed materials such as: product labels, containers, brochures, among others.
• Documents expected to be returned by COFEPRIS after reviewing your request including medical prescriptions, invoices, certificates, power of attorney, etc.
• Any other document when it is disordered, illegible or incomplete.

Paper size

• You must use letter size sheets for all the dossiers.
• Legal documents can be presented in A4 or Legal size.
• All documents larger that a letter size sheet must be folded by the lower edge to fit.

Digital media storage devices (DMSD)

The following rules must be followed when attaching a DMSD (i.e.  CDs, DVDs, USB flash drives):

• Mark DMSD with an adhesive label and/or permanent marker.
• Add a properly numbered sheet including the description of the DMSD included and its content.
• Place the digital media and their description sheet inside a sealed sheet protector.
• When you include a CD or DVD it must be inside an envelope, not to use plastic boxes.

Dossier organization

The content included in the dossier must be arranged as follows:

• Identify the proper COFEPRIS code submitting evidence that all requirements are met to choose the COFEPRIS code in the dossier.
• Submit all the information in the original language and its translation into Spanish when applicable. Expert translation is required for legal documents.
• Sort the information included in the dossier according to the checklist for each kind of request, prevention or as requested by COFEPRIS.
• Send all necessary information in a single dossier as no further information is accepted.

For new requests, free writings and response to preventions:

• The dossier must include a cover with the following data:

1. Number of submission (will be filled by COFEPRIS).
2. Number of initial request (only for preventions).
3. COFEPRIS code.
4. Name and type of request.
5. Company name.
6. Keywords of the request reason (new request, response, and consultation.)
7. Number of sheets included in each file.
8. Total files.
9. Name and signature of the sanitary responsible or legal responsible.

• Request form (filled and complete).
• Deposit receipt, original document and two copies inside a sheet protector.
• Table of contents.
  • This section must mention at least the documents that by requirement are integrated into the application (the order of the checklists should be followed when applicable).
  • Consider at most three levels of detail and identify the numbering in which each section is located.
• Information corresponding to the requirements.

We strongly recommend to follow this guide to avoid any complication during the COFEPRIS submission. To learn more about these rules please contact Veraque.

Also, check our guides for further details and hints!

The post New Cofepris submission guide appeared first on Veraque.

Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this brief overview, we will describe what you need to register your medical device in Mexico and some key facts to take into account making this process easier for you and your team.

Medical Devices in Mexico are regulated by COFEPRIS (COmisión FEderal para la Protección contra Riesgos Sanitarios), a Federal Commission that belongs to the Ministry of Health.

Most of the times, a medical device in other countries is also considered a medical device in Mexico. Nevertheless, it is necessary to confirm the classification and grouping through local legal guides. This is the first step we recommend you to take.

In addition, there is an option to work with Third Party Reviewers. These are COFEPRIS approved entities that deliver a pre-approval. COFEPRIS considers this pre-approval as a proof that another expert has evaluated the dossier resulting in an expedited review and response. An option if you want to have timeframe certainty or agile feedback.

As in other countries, there are different regulatory pathways to register a medical device:

• Standard Process.
  • Time: Even though there are official timeframes, you should consider at least 12 months to receive a response.
    • Third Party Reviewer: As an alternative, you can choose a Third Party Reviewer. This will take around 3 to 6 months upon submission.
    • Third Party Reviewer fee: $2,000-4,000USD depending the reviewer and the device class.
  • COFEPRIS fee: $500-1,100USD depending the device class.
• Equivalency agreement.
  • Applicable for products approved by US FDA, Health Canada (only for Class II-IV) and Japan (only for Class II-IV).
  • Time: 8-11 months for FDA and HC approved products and 5-8 months for Japan.
  • The option for Third Party Reviewers is not applicable for this route.
  • COFEPRIS fee: $500-1,100USD depending the device class.

Holding

In Mexico it is necessary to have a Registration Holder who owns the registration. The Mexican Registration Holder (MRH) also must be a Mexican legal entity.

• Main responsibilities of the holder:
  • To be the main point of contact in Mexico with COFEPRIS.
  • Apply for any process with COFEPRIS, related with the registrations or any product.
  • Report any incidence, in terms of Technovigilance

• Benefits of having a holder as a commercial partner:
  • Assign or remove local distributors, avoiding dependence with them.
  • Have a local ally, with local presence to oversee your sanitary authorizations.

Post-authorization activities

When the registration is released from COFEPRIS, you are able to sale your medical devices. It is important to consider that any change in the sanitary registration conditions must be notified through a modification process.

On the other hand, the registration is valid for 5 years only and can be renewed for 5 more years.

Finally, in case your medical device is related to an adverse incident, your holder must report it to COFEPRIS. The effective holder’s role in such cases will be determinant for a successful surveillance process.

In conclusion, to have a great experience registering a Medical Device in Mexico, we recommend establishing a strategy, starting with a classification. Then, evaluating the most suitable regulatory pathway (standard, equivalency or third party) and finally consider your post authorization duties. Our last advice is carefully choose your Sanitary Registration Holder. As discussed, this entity plays a major role as your representative in Mexico.

For more information, check similar notes in our Guides.

In case you have any question or comment, please feel free to contact us at contact@veraqueconsulting.com

The post Medical Device Regulatory Overview (Mexico) appeared first on Veraque.