Medical Device Blog – QA & Regulatory Updates from Emergo Group

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Mexico Expands Equivalency to Devices Registered in Japan

Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical devices registered in the US or Canada to some devices approved or certified for sale in Japan.

COFEPRIS equivalence will apply to devices classified as Class II, III or IV in Japan; products registered as Class I devices in Japan must still go through the standard registration process in Mexico.

Manufacturers of qualifying devices must have either approval issued by Japan’s Ministry of Health, Labor and Welfare (MHLW) or their certificates issued by a Registered Certification Body in Japan.

Some of the documents that manufacturers must also provide in order to qualify for expedited review in Mexico are:

Operating license
Notification of Exportation
Original Certificate of Free Sale
Original Letter of Representation
Labels and Instructions for Use

The expanded Equivalency Agreement will go into effect February 24, 2012. Interest in the Mexican market has already increased over the past year due to expedited review options for manufacturers registered in the US and Canada; similar interest from medical device companies registered in Japan will no doubt also grow once the new agreement is implemented.

Markets: Japan, MexicoTags: COFEPRIS, equivalency agreement, Japan, medical device, Mexico, PMDA

Author: Stewart EisenhartDate: January 26, 2012

Mexico Updates Lists of Class Ia Devices, Third-Party Reviewers

Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in the regulator’s Official Diary.

According to Emergo Group sources in Mexico City, manufacturers whose devices qualify for Class Ia classification could face a much simpler registration process, but notification as well as Mexico Registration Holder representation will likely still be required for such products.

In addition, COFEPRIS has officially released a list of approved third-party reviewers for the standard medical device registration process. (This list has yet to be published in the Official Diary, however.)

We will keep you further informed of these changes as more details emerge from COFEPRIS.

Markets: MexicoTags: COFEPRIS, medical device, Mexico, mexico registration holder, mrh

Author: Stewart EisenhartDate: January 12, 2012

Mexico to Introduce New Class for Low-risk Medical Devices

Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.

Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.

According to our sources in Mexico, implementation of the new requirement will happen sometime in the next three months, and COFEPRIS has yet to issue details of how affected manufacturers will have to register their devices in order to comply with Class 1A rules.

We will keep you informed as we learn more about this development.

Markets: MexicoTags: Class 1A, COFEPRIS, medical device, Mexico

Author: Stewart EisenhartDate: October 18, 2011

Mexican Regulators May Allow Third-Party Reviews of Medical Devices

Mexico’s medical device regulator COFEPRIS is considering utilizing third-party reviewers (link in Spanish) to speed up submissions under the standard registration process.

In mid July, the regulator published a notice to interested companies to apply within 30 days for consideration to be designated third-party reviewers. Class I, II and III device registration submissions would be eligible for third-party review according to the notice.

Firms applying to serve as third-party reviewers for COFEPRIS must meet five general requirements.

First, application forms must be submitted to COFEPRIS within 30 days of the notice’s publication.

Second, applicants must be legally incorporated under Mexican law, or in the case of individuals, naturalized Mexican citizens.

Third, applicants bust provide written attestation under oath that their products, processes or services comply with Mexican Standard NMX-EC-17020-IMNC-2000.

Fourth, applicants should meet the requirements of Article 211, Section II of the Rules of Inputs for Health in terms of having the technical and financial resources—including liability insurance—to properly conduct third-party reviews and inspections.

Fifth, applicants must be under no direct influence of any manufacturer, importer or other party that could cause conflicts of interest regarding registration reviews.

Additional documentation requirements are listed in the COFEPRIS notice; an English translation (via Google) of the requirements is available here.

If COFEPRIS ultimately does implement a third-party review system for standard medical device registrations, the move would add additional efficiencies to the Mexican device registration process and further increase the market’s appeal to foreign manufacturers.

Markets: MexicoCategories: Regulatory ComplianceTags: COFEPRIS, medical device, Mexico

Author: Stewart EisenhartDate: August 3, 2011

Mexico to Ease IVD Registration Process

Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.

According to officials at COFEPRIS (document in Spanish), the regulator’s moves are based on methods endorsed by the Federal Regulatory Improvement Commission (COFEMER) and recommendations from the Organization for Economic Cooperation and Development (OCDE).

Along with IVDs, COFEPRIS plans eased registration for hygienic products, healing products and dental supplies. As for the 1,700 products that will no longer require registration as medical devices, COFEPRIS will publish a list of these goods in August on its website, www.cofepris.gob.mx.

Simplified registration requirements for IVDs should boost the Mexican market’s appeal for IVD manufacturers looking to expand into new markets. Emergo Group will continue to monitor the situation for further details.

Markets: MexicoTags: COFEMER, COFEPRIS, IVD, Mexico, OCDE

Author: Stewart EisenhartDate: July 18, 2011

Mexican Market Entry Just Got Easier

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms.

The Mexican Health Authority’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) has put into effect new rules recognizing medical device authorizations for Class I, II and III commercialized products in the US, as well as for Class II, III and IV commercialized products in Canada. A new eJournal article from Emergo Group explains the specifics of the new rule that COFEPRIS has made available, but many details remain forthcoming. Suffice it to say that going forward, it appears as though medical device and IVD manufacturers already authorized to sell their products in the US or Canada will enjoy a two-for-one (or three-for-two) deal when it comes to achieving regulatory approval in all three major North American markets.

Bottom line: Depending on the classification of their products, medical device and IVD manufacturers already authorized by either the FDA or Health Canada can extend their marketing to Mexico without any significant new regulatory hurdles.