In recent months there have been new changes in laws and regulations that had led to an international tender for the consolidated purchase of medicines and health supplies for the public sector in Mexico. This is not the first time such process is made, the key difference is that UNOPS (United Nations Office for Project Services) will be in charge of it.

In this article we provide an updated summary highlighting some key facts about the regulatory requirements.

Overview

Last October the 5^th, took place an open informative session organized by the UNOPS presenting details about the first international tender. As previously announced, the aim of this tender is to reduce costs for public health institutions (IMSS, ISSSTE, Sedena, PEMEX and the 32 states of Mexico). It is also projected that its value is around 100,000 million MXN (around 4,725 million USD).

Regulatory requirements

During this session the COFEPRIS commissioner, Dr. José Alonso Novelo, mentioned that derived to the agreement released on January 28, 2020, the general requirement to participate in this tender is:

• to have a sanitary registration in the country of origin issued by a recognized Regulatory Agency from the following countries:
  • Swiss, EU, USA, Canada, Australia
  • or be included in international programs like the WHO prequalification programs as well as those related to PICS members.
• If a sanitary registration in Mexico is not granted by the time a favorable response is received, the interested manufacturer must show evidence of the sanitary registration submission within the 5 days of the arrival of the products to Mexico.

 Milestones

Based on this report it is programed that from January to April 2021, the Government will start receiving the supplies in Mexico.

 Conclusions

Though, it is not the first time the government in Mexico releases international tenders, this represents the first trial to work with international parties (UNOPS) to improve the efficiency and avoid corruption within the institutions.

In addition, we consider that a major advantage for international manufacturers is that they do not necessarily need a sanitary registration in Mexico. Nevertheless, it has been clarified that it must be eventually requested.

Finally, it is worth mentioning, that if this process represents savings and concludes in an efficient and transparent acquisition. The government in Mexico expects to keep using this tool.

If you are medical device manufacturer interested to participate in this bid or those programmed in the following years, send us an email to contact@veraqueconsulting.com to receive more information about it.

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Even though several statistics has been reported, we could not find resources about the Mexican medical device market for this year. And many questions arises among this turmoil. Therefore, we considered that making a research from different public data bases, central banks mainly, would provide some light for fair conclusions.

In this article we present a brief summary of this work. Specifically, the importation/exportation value in Mexico compared to other countries. We also add some facts about the healthcare system and the local market. This will help you to get a better picture of what it is still considered the second largest market in Latin America.

The Mexican Market

After reviewing the Mexican central bank data bases and matching them with the UN’s, we found that Mexico is in the 9^th place in terms of medical device importations (as referred in the table below) and the 4^th place in exportations*

*Notes:

The information is obtained based on the most representative tariff codes related to medical devices.

Data up to July 2020.

China is not considered. But it is inferred within the first 5 countries based on other reports from previous years.

The Local Medical Device Sector

There are approximately 170 Medical Device manufacturers and nearly 2000 distributors located in Mexico**. The major cities concentrating them are in Mexico City, Monterrey, and Guadalajara.

** Data from COFEPRIS public data bases.

Changes in the industry

Recent changes in the Mexican healthcare system has taken place in 2020. Some points to consider:

• The public healthcare system plans to make a mega purchase via the UN.
• The regulatory agency (COFEPRIS) changed its legal structure.

Conclusions

Mexico remains in the top 10 countries in the Medical Device Industry for importations and exportations. On the other hand, even though the local regulation has changed, it is not closing the market to new players. In fact, they have open alternatives to attract manufacturers with lower prices –a trend for which Mexico is not the exception in the world.

We trust you have found this article useful. If you need more information, please send us an email to contact@veraqueconsulting.com

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By International Treaties and Agreements, the purpose of authentication is to certify the authenticity of a legal document and the signature of the public servant. There are two main types of authentication accepted for most of the countries:

1. Legalization: This is the most common process. It basically consists of a chain authentication of the legal document involving several officials in the country of issuance. The final step is carried out by the Embassy or Consulate of the country where the document is to be used. This is a slow and expensive process. Legalizations are accepted in the countries signed the treaty called the Vienna Convention on Consular Relations.
2. Apostille: This is a simplified process consisting in the issuance of an authentication certificate known as Apostille. This authentication is performed by an authority designated in the country of issuance of the legal document. This authentication process is accepted in those countries that signed the Hague Convention of 5 October 1961 Abolishing the Requirement of Legalization for Foreign Public Documents.

The Apostille is a rapid, inexpensive, and useful method of authentication. However, the documents must fulfill some characteristics to be Apostilled:

• The country of origin and destination of the document must be member of the Hague Convention, if this is not the case, Legalization is the only option.
• The document must be considered as a public document.
• The Apostille is only for documents to be used abroad.

Some documents of interest for the medical devices industry that can be apostilled are the following:

• Free Sale Certificates,
• Good Manufacturing Practices Certificates,
• Extracts from commercial registrations,
• Patents,
• Notarial acts,
• Acknowledgement of signatures,
• Letters of Representation,
• Contracts and Agreements between companies and manufacturers.

In addition, an Apostille can only be issued by a Competent Authority in the country of origin of the document. Apostilles are affixed to legal documents on the same document if there is enough space. Otherwise, the Apostille can be attached in a separate sheet. Finally, there is a standardized template for all member countries to issue an Apostille document. However, some countries can add more information or they can even issue digital Apostilles.

The minimum 10 points with information of the Apostille are listed in the model below:

APOSTILLE

(Convention de La Haye du 5 octobre 1961)

1. Country: …………………………………………..

This public document

2. has been signed by ……………………………………………………….
3. acting in the capacity of ………………………………………………..
4. bears the seal/stamp of ………………………………………………..

Certified

5. at ………………………………… 6. the …………………………………
6. by ………………………………………………………………………………..

…………………………………………………………………………………….

8. No ……………………………….
9. Seal/stamp: 10. Signature:

……………………………………. ………………………………………….

The Apostille can be issued in French and in the official language of the country of origin of the document. It might be necessary to translate the Apostille.

It is worth to mention that apostilles only certified the signature or seal of the person or official authority included in the document. The Apostille does not certify the content of the document.

The Apostilles can be rejected in the country where the legal documents be used when:

• The Apostille does not certify the signature correctly,
• The origin of the document cannot be verified,
• The Apostille was placed over the original text of the document.

To know more about obtaining a document correctly authenticated and ready to be accepted in Mexico, please contact us at contact@veraqueconsulting.com

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As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender binding for all those companies interested to sell medical supplies in Mexico (medical devices included). This is for the period 2021-2024. In this article, we would like to explain some of the reasons behind this bid and opportunities you may find interesting.

During this year, the Mexican Government expressed the necessity to acquire low prices medical supplies with the support of international entities. This was legally approved in the official diary the last August 11. Such amendment, basically allows the Mexican Government to acquire any product without following the rules that used to be the legal basis for every public bid performed in Mexico.

A few days after such legal amendment, the Government worked with the UNOPS to publish the procurement of medicines and medical aid supplies (medical devices) in Mexico. These are a few key facts to consider:

• Published: 25-Aug-2020
• Deadline: 15-Sep-2020 23:59 (GMT -5.00) Central Time (US & Canada), Mexico City
• 900 type of medical devices required

In addition, it was also reported that:

• Participants do not necessarily require to present sanitary registrations approved in Mexico by COFEPRIS
• It is expected that for 2021 the value of this bid would be approximately $6 billion USD

It is worth mentioning that this is the first time the Mexican Government makes such acquisition process. And this is important to the country, considering that the public sector covers 70-80% of the total medical services.

Even though a COFEPRIS sanitary registration is not a requirement to participate, we found in the official UNOPS platform that once you submit your application, they asked you if a COFEPRIS sanitary registration has been granted. This does not necessarily implicates that you need such registration.

From UNOPS webpage (taken on August 9^th 2020)

In conclusion, there is still uncertainty if this process will effectively promotes a real benefit on prices. Nevertheless, we consider that if you are a medical device manufacturer with local sanitary approvals in your country, this could be a great chance to get into the Mexican market.

In case you are interested to know more about this bid, please send us an email to contact@veraqueconsulting.com

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COFEPRIS has initiated an ambitious project to digitalize the regulatory processes in a similar way to other regulatory agencies. The aim of this transition to paperless systems is to speed up the response times, reduce bureaucracy, eliminate corruption, and dismiss discretionary practices.

The first stage in this strategy was concluded in 2019, which mainly consisted on performing a full diagnosis of the current process.

The second stage has been implemented on September 1, 2020. Specifically, COFEPRIS released a new electronic system to schedule the submission of requests and procedures in the Integral Service Center (CIS). It is worth mentioning that in order to use this new system, an electronic signature, known as e.firma, is needed. Specifically, the e.firma is a confidential file used to retrieve financial and taxes information from the company. In addition, this electronic signature is only granted to legal entities located in Mexico.

The above changes will bring benefits for the COFEPRIS and users of their services. Even when COFEPRIS is still accepting priority requests, the CIS have been opened for all users since September 1, 2020 with strict hygienic measures to avoid the propagation of COVID-19.

The third stage of this project consist in the process mapping, analysis and design of optimal procedures and simplified pathways for its digitalization.

The intention of COFEPRIS is to optimize requests through the standardization and reduction of processes. They are also looking to digitalize the whole regulatory procedures. As an example of this, all type of Import Permits are requested digitally in VUCEM.

Thanks for reading this article. For more information, check similar notes in our Guides.

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Up to August 19, 2020 according to the Health Law, COFEPRIS was a separated administrative commission but part of the Ministry of Health, with technical, administrative and operative autonomy.

However, some changes were performed in the Mexican laws that changed this scheme. In this article we summarize those amendments and its possible consequences.

In August 19, 2020 an official agreement was published. In this agreement the internal structure of the Ministry of Health is changed. These changes include the modification of COFEPRIS from being hierarchically dependent from the Ministry of Health to a lower level. Specifically, as a Direction that depends on the Sub secretary of Prevention and Health Promotion. As a reference, the head of this entity is Hugo López Gatell, public servant that have been in charge of handling the COVID-19 pandemic in Mexico.

In addition of this amendment, it is expected that the Mexican Congress will modify the Health law to legitimize these changes and make the laws coherent. Up to date Lawmakers have not declared regarding this issue.

The above-mentioned changes means that COFEPRIS will lose its autonomy from the Government, unlike most regulatory agencies from other countries. The Federal Commissioner who was the head of COFEPRIS will disappear, now all decisions will be taken directly by Hugo López Gatell.

Specialized analysts have noticed that this modification will negatively impact the health care industry. They expect an increase in bureaucratic procedures and decreased quality, efficacy and professionalism in the function of the COFEPRIS.

According to experts, these changes represent a drawback to the times before the creation of the COFEPRIS in 2001, when the regulatory procedures were deficient. It is important to mention that these observations do not represent the opinion of Veraque regarding this topic. However, we noticed consistency in this judgment.

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 COFEPRIS legal structure changes appeared first on Veraque.

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.

In this article we will focus on explaining strategies to classify and group orthopedic implants following simple general rules and explain some particularities that can be found in these type of devices according to our everyday experience.

As an alternative, we also prepare a video with a brief summary of this article.

General characteristics of Orthopedic Implants

Most orthopedic implants are sold with the surgical instruments necessary for their placement. These devices are packed in stainless steel boxes including non-sterile implants and instruments to be autoclaved. However, there are cases in which the instruments or implants are sterilized from origin by the manufacturer.

On the other hand, any company could have a single kit of surgical instruments to be used with several commercial brands of orthopedic implants. This situation has regulatory implications that we will explain in the following sections.

Classification according to the level of risk

Orthopedic implants by its nature are classified as long-term implantable (invasive) medical devices and according to their level of risk are generally classified as Class III – Rule 8.

Moreover, instruments used to place these implants are considered as surgical materials and can be classified as class I or class II according to their characteristics:

• When reusable and usually not sterilized (Class I). Rule 6.
• Single use and sterilized (Class II). Rule 6.

Grouping for Sanitary Registration purposes

Surgical implants can be grouped in the same Sanitary registration if they:

• are made by the same manufacturer,
• have the same brand name or trademark and the same intended use and
• are manufactured with the same materials and technology.

On the other hand, surgical instruments follow the same rules plus:

• it is not possible grouping single-use sterilized surgical instruments with non-sterilized versions, because each type has a different classification.

Additional considerations

After reviewing the classification and grouping criteria, it is worth mentioning that a separate sanitary registration must be requested for each trademark.

Furthermore, all instruments must be registered separately, and it is recommended to group instruments intended for the same type of implant. The only exception are general surgical instruments (which are not intended for any particular implant). In this case they must be grouped by its indication of use, with the same criteria as class I (non-sterilized), class II (sterilized).

Finally if the implant is packed with the sterilized instruments, it can be included in the same sanitary registration. This is a common case in arthroscopy supplies. In this case, the product will be considered as Class III.

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.

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A rights transfer is a legal procedure where the Sanitary Registration Holder is changed. In this process the original owner of a Sanitary Registration transfers its rights to another company (the new Holder), as long as critical conditions previously authorized are not changed.

The new Holder acquires the rights for manufacturing, importing, exporting, and marketing the product(s) endorsed by the Sanitary Registration. Other obligations (like surveillance activities) related to the ownership of a Sanitary Registration are also acquired.

In this article we explore the main characteristics of a rights transfer, dividing this process into two parts for a better understanding:

1. Rights transfer legal procedure through a public notary.

The rights transfer is performed by means of a contract or written agreement in which the holder of a sanitary registration agrees to transfer the ownership (rights) to a third-party company. Due to the legal nature of this procedure, the agreement must be signed by both parties through a notary.

It is worth mentioning, that there is not a standardized document to carry out such process since the conditions of the agreement may differ in each case. However, there are templates that can be used whenever these contracts are agreed among parties. In addition, there is no need to get an approval by COFEPRIS for this document since civil law is not a field of its competence.

On the other hand, the company that cedes the rights must provide to the new holder, all the original and official documents related with the sanitary registration. This includes, modifications and proof of submission under evaluation by COFEPRIS. Likewise, backups of all the dossiers, either in digital or physical format, must be provided for safekeeping by the new holder.

2. Sanitary registration holder modification with the Mexican Ministry of Health

Article 190 of the Health Supplies Regulation indicates that the new holder must communicate any rights transfer to the Mexican Ministry of Health (through COFEPRIS), within a period not exceeding thirty (30) days from the date on which it was made, attaching the public document where the rights transfer is recorded.

On the other hand, general requirements to perform such modification are:

• Updated project label.
• The public deed where the rights transfer is registered (certified copy or original).
• The original sanitary registration.
• Copy of the health license or operating notice of the new holder.

In this procedure, the new holder can change or add importers and distributors. It is only necessary to present the respective operating notice and representation letters approved by the manufacturer.

If you have further questions about how to process a rights transfer for any sanitary registration, please feel free to contact us at contact@veraqueconsulting.com.

The post What do you need to transfer your sanitary registration in Mexico? 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.