MEXICO | The Secretary of Health, Salomon Chertorivski announces Equivalence Agreement with Japan for Medical Devices

•  The goal is to expand the supply of Japanese leading-edge medical equipment to Mexicans and strengthen the competitiveness of the economy.

•  Under Secretary for Industry and Commerce, Lorenza Martinez, and the Ambassador of Japan in Mexico, Shuichiro Megata, attest the Mexican government's decision.

•  COFEPRIS shall recognize the registrations of the Japanese agency, which will expedite the entry of medical devices.

In order to expand the supply of last generation medical equipment into our country and to strengthen the competitiveness of the economy, the Secretary of Health, Salomon Chertorivski Woldenberg, today announced an Agreement of Equivalence in Matters of Medical Devices between Mexico and Japan.

The health minister stressed that the equivalence agreement will allow Mexican patients to import expeditiously medical device technology for the treatment of various diseases related to oncology, hypertension, neurosurgery, ophthalmology, orthopaedics, cardiology, neonatology, and others.

In announcing the agreement in the presence of the Undersecretary of Industry and Trade of the Ministry of Economy, Lorenza Martinez, Ambassador of Japan in Mexico, Shuichiro Megata, and the head of the COFEPRIS, Mikel Arriola, the Secretary of Health stated that Mexico's health agency will recognize registrations of medical devices issued by the health agency of Japan, which will streamline import procedures, bring investment, raise the competitiveness of the economy and create more jobs.

The agreement with Japan, said Secretary Chertorivski, adds to the agreements we already have in place in this area with the health authorities of the United States and Canada, which have allowed us to significantly reduce the time of entry into the country of last generation medical equipment that Mexicans need.

For its part, the Federal Commissioner for the Protection against Sanitary Risks (COFEPRIS), Mikel Arriola, pointed out that the equivalence agreement with Japan complies with the strategy announced by President Felipe Calderon to simplify the paperwork in the health sector in order to promote the commercialization of innovative medical devices without jeopardizing public health.

He explained that, under agreements with the United States and Canada, which were published on October 26, 2010 in the Official Journal of the Federation, the waiting time to obtain the authorization of a register for medical devices has been reduced by one-third, and this is expected to be the case with products that are imported from Japan, as the Ministry of Health, Labour and Welfare of that country is also a guarantor of quality and safety standards.

He explained that the submissions that have entered under these agreements accounted for 25% of total new registrations handled by the COFEPRIS and hopes that the agreement announced today makes that figure grow significantly.

The Commissioner Arriola said the agreement was achieved after several technical meetings and is the result of consensus among regulatory agencies in both countries which, above all, ensure the protection of the general population.

The head of the COFEPRIS emphasized that accepting the registrations of the Japanese health agency does not mean that the Mexican health authorities will stop conducting health checks and monitoring of products and facilities that are imported under this agreement.

Japanese Medical Devices have about 10% of the world market share. In 2010, 91% of products registered by the COFEPRIS were of foreign origin, 44% of which came from the United States and Canada, while the rest came from other countries of Europe.

Posted on: Jan 31, 2012

UPDATE ON MEDICAL DEVICE PRODUCT REGISTRATION TURN-AROUND-TIME FOR SINGAPORE

With the implementation of the Medical Device Regulations since August 2010, HSA has been experiencing a very high volume of product registration applications for all device categories. Despite the Arazy Group ramping up capacity to meet this high volume, the higher volume and complexity of products being submitted for application have resulted in processing times being longer than the current published turn-around-time (TAT).

Hence, in response to feedback from industry, we have clarified the TAT (Turn Around Time) for Medical Device Product Registration, to better reflect the status of applications received:

Risk Classification	TAT for Abridged Evaluation*	TAT for Full Evaluation*
B	100 working days	160 working days
C	160 working days	220 working days
D	220 working days	310 working days

Incorporating a Medicinal Product

310 working days (Device will be jointly evaluated by the Medical Device Branch and the Pharmaceuticals and Biologics Branch. Actual TAT will vary depending on the type and nature of product. For example, new medicinal chemical entity might require longer evaluation time than a well characterised chemical entity)

*This TAT excludes the period in which the stop-clock for any input request to the applications
and the time period in which any expert opinion will be needed to evaluate the application.

For Class A Medical Device Product Registration applications, the TAT for review is 60* working days.

Posted on: Oct 31, 2011

LATEST CHANGES TO THE ANVISA REGIME

OVERLOOK OF THE ANVISA REGIME FOR MEDICAL DEVICES
Medical devices can be authorized by ANVISA by way of two different processes, known as "cadastro" and "registro" after their names in Portuguese. Since both words translate into English as "registration", for the sake of clarity the names in Portuguese will be used in this report.
“Cadastro" is a simpler and faster process which generally applies to class I and class II devices, except for a set of specifically listed “exemptions”. When a product is “exempted from cadastro”, that means it must go through the “registro” process.
“Registro” is a longer and more complex process, which applies to all class III and IV devices, and to all class I and class II products “exempted from cadastro” as noted before, as stated in ANVISA’s Resolution RDC 25 of 25 May 2009.
As from 22 May 2010 ANVISA started to require that all “registro” submissions include a BPF Certificate of Registration, issued by ANVISA itself. The acronym BPF for “Boas Práticas de Fabricação” in Portuguese is equivalent to GMP after “Good Manufacturing Practices” in English. Ever since this resolution was published in May 2009 there was widespread concern about ANVISA´s capacity to audit manufacturers all over the world. It soon became obvious that ANVISA did not have the resources to inspect manufacturers within the time frame established by law, which theoretically should be not more than 90 days after the inspection is requested. In our experience, manufacturers have been experiencing waiting times well over 9 months.
In order to decompress the situation ANVISA took additional measures, namely:
- Establishing self-inspection as a valid option for on-site inspections, though only under certain specific circumstances
- Extending the period between inspections from 1 year to 2 years

However, these measures did not suffice.
RECENT DECISION REDUCES THE SCOPE OF EXEMPTIONS TO “CADASTRO”
ANVISA has released its Regulatory Instruction No. 2 (IN 2/2011), which will simplify the process to the market for many manufacturers of low-risk electro-medical devices. This instruction redefines the list of products that are exempted from “cadastro”, i.e. for which “registro” remains compulsory.
To begin with, this Regulatory Instruction contains a list of the products which, in spite of falling within classes I and II, are still excluded from “cadastro”, namely:
- Equipment used to disinfect and sterilize medical devices.
- Equipment to process blood components for infusion.


- Medical Software that does not form part of a medical device and is used for medical imaging with diagnostic or surgical purposes.
- Products for in vitro diagnostics, such as biochemical or immunoassay analyzers, glucose meters used in testing of samples derived from the human body.
- Reprocessed hemodialysis devices.
- Equipment for processing medical images.
- MRI and ultrasound imaging equipment.
- Devices that produce in vivo images of distribution of radiopharmaceuticals.
- Endoscopic systems for surgical applications.

One of the most significant changes, as compared to its repealed predecessor, IN 7 of June 7 2010, is that products falling under classes I and II that require the INMETRO mark of electrical safety are no longer subject to compulsory “registro” by default. This has cleared the way for a wide variety of low risk electro-medical devices to be authorized through “cadastro” at a fraction of the time and the cost.
It must also be noticed that for medical devices falling in classes I and II that are not in the current list but which nevertheless have innovative indications or technology, despite going through the “cadastro” process, documented evidence of their safety and efficacy is required. This also applies to devices with a measuring function, for which information regarding metrological issues should be provided.
August 2011
 

Posted on: Oct 12, 2011