Saturday 19 May 2012

MexicoCOFEPRIS

Overview of Medical Device Approval in Mexico (COFEPRIS Certification)

Medical device, including IVDs, face the challenge of gaining pre-market clearance in a variety of countries with regulatory frameworks that can vary widely. One approach to simply a global sales model is to apply for ISO 13485. This however, only serves as part of the documentation and cannot replace meeting regulatory requirements for any particular country.

Food Court over the next couple of weeks will provide a brief overview of the regulatory systems in different countries. Today’s post explores the system in Mexico.

Time and Cost

Medical device manufacturers often want to know right off the bat how long will it take before sales can begin. In Mexico there is the official time provided by COFEPRIS (the US FDA equivalent) and what it will actually take. The offical time frame for standard review varries by the type of device but will typically take years. Yes, years. The Mexican government pushed a policy in 2009 that required all medical device manufacturers to re-register with COFEPRIS, which created a massive backlog. There is aexpediated review that while stringent can provide approval in 3-4 months.

It’s key to remember that registration in Mexico is now on a 5year renewal cycle. Manufactuers will need to plan at least 8months in advance to make the renewal deadline and avoid re-registration.

The cost depends on COFEPRIS classification of devices and ranges roughly between 650 and 1200 USD.

Standard Process

The standard process requires the following steps (stated without all the regulatory detail they entail):

  1. Home Country Approval: your device must be approved in its country of origin (i.e. for a US manufacturer approved by the FDA). The only exception is for the fast track process discussed below.
  2. Mexico Registration Holder (MRH): This is somewhat similar to the US FDA’s initial importer requirement. COFEPRIS wants a Mexican legal entity registered with the government with qualified personnel to be at the warehouse to manage recalls and generally act as a local point of contact. The MRH will ensure warehouse requirements are met (i.e. temperature or radiation controls) and applies for permits to import products. The MRH holds or ‘owns’ the COFEPRIS certification when approved, this is a lot of control and the entity and personnel must be chosen carefully. Any changes to the certification must be thourgh the MRH. The MRH is also responsible for all Ministry of Health recalls or reportable events.
  3. Device Classification: COFEPRIS based device classification off of the EU Medical Device Directive (MDD) and combined it with the EU IVD Directive. There are three types of devices that roughly match the MDD. There are two additional rules not found in the MDD. Rule 20 is for hygiene products, like dandruff shampoo. Rule 19 is an extension of the IVDD it governs high risk IVDs like AIDs kits. IVDs in Mexico are either Class I Rule I or Class I Rule 19.
  4. Additional Factors in Classification: There are harmonized tariff codes, grouping or family criteria and low risk devices, like scales and hospital gowns, to consider when determining a device’s classification. It’s also important to evaluate accessories to determine if they are exclusive use accessories or general. Exclusive use accessories generally can be registered as a group.
  5. Quality System Requirements: COFEPRIS traditionally doesn’t come on-site, but under new draft guidance NOM 242-11 that may change. To meet the QSR a manufacturer can use ISO 13485 or home country certification like the Establishment Inspection Report from the US FDA.
  6. Technical File: The technical file is extensive. It must include:
  • Technical information, drawings
  • Testing results (if applicable)
  • Labeling information in Spanish (Labeling guidance available NOM 137-SSA1-2008; similar to EC)
  • Instructions for Use in Spanish
  • Manufacturing Information
  • Clinical Data (for some products)
  • Proof of Home Country Approval (standard Process)
  • Proof of complying with US FDA/Health Canada requirements (Expedited Process)
Additional requirements are in place for devices that omit radiation (a license from Dept. of Energy) and high risk devices like HIV test kits and implantable devices. High risk devices are usually set on a day or quantity limit to ensure close communication with COFEPRIS and improved traceability.

Expedited Review

In addition to the technical file to leverage FDA approved devices all of the following are required:

  1. Certificate of Foreign Gov’t;
  2. 510(k) or PMA letter or screen shot of registration for class I;
  3. History of reportable events/recalls
  4. Establishment Inspection Report showing audited by the FDA
Requirement 4 is strict – no ISO or alternative criteria can be used in substitution. This often means for a class I device or a manufacturer who has never been inspected or provided a report expedited review is out.
To leverage a Health Canada approval all of the following are required:
  1. Class II, III, IV are eligible
  2. ISO 13485 Cert with CMDCAS, certificate, and proof that their registrar is certified to inspect to Health Canada’s QMS requirements.

Approval and Post Approval Activities

Once the above information is provided it will be under review. When approved a certificate will be issued to the manufacturer and MRH, which allows the MRH to begin importing (provided permits are obtained).

The MRH is the master distributor. If additional distributors are sought add them in the beginning (especially if using the expedited review) with a Letter of Distributor (providing permission to import) and list them in the application. To add a distributor the MRH will need to issue a letter of representation and make an administrative change in the registration (there will be a small fee).

Any change no matter how minor must be provided to the Ministry of Health and COFEPRIS. The time frame is usually around 3 months to gain approval of changes. COFEPRIS recently stated it is working to improve the turnaround of modifications to around 22 business days.

To learn more visit
510(k) and International Device Approval

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