My Presentation on Mexico Medical Device Regulations

MEXICO Medical Device Regulations

Introduction We represent Trojan Consultants and we have been hired by TrojanCare (manufacturers of Insulin Infusion Pumps) to guide them in their effort to register their first product in Mexico We will address: Demographics Disease Profile Healthcare Spending Market Product Regulatory environment Registrations requirements Advantages Challenges

Demographics Estados Unidos Mexicanos - United Mexican States Located in North America between Belize and the US Area: 1,972,550 km 2 Source: CIA - The World Fact book Population: 109,955,400 (7/08 estimate) 31 states + 1 federal district Official language: Spanish Currency: Peso [Conversion: 1 US $ = 12.64 pesos]

Last 60 years: improved medical care and sanitary conditions Increased life expectancy from 49 years of age in 1950 to 72 years (M) and 77 (F) in 2003 Demographics have shifted – population largely composed of adults and elderly Life Expectancy

Disease Profile Fifty years ago, the leading causes of mortality were attributed to parasitic, infectious and respiratory diseases Today, the leading causes of mortality depend on the geographical area Respiratory infections are prevalent in rural areas but chronic conditions such as CV disease and diabetes are leading causes in urban areas As chronic conditions continue to increase and incidence of infections decline, demographics are changing to resemble those of developed countries

Leading Causes of Death Source: World Health Statistics Top ten causes of death, all ages (2002) Causes Deaths % All causes 100 Diabetes mellitus 12 Ischemic heart disease 11 Cerebrovascular disease 6 Perinatal condition 6 Cirrhosis of the liver 5 Chronic obstructive pulmonary disease 4 Lower respiratory infections 3 Congenital anomalies 3 Road traffic accidents 3 Hypertensive heart disease 2

Diabetes Mellitus Source: World Health Statistics

Healthcare Spending 43% - public sector 5% - private sector 52% - out-of-pocket expenses 2004: Popular Insurance (Seguro Popular, SPS) introduced with goal to provide universal health coverage by 2010. In 2008, the timeline was extended to 2030.

Market Mexico is the largest pharmaceutical market and the second largest medical device market in Latin America In 2007, pharmaceutical market growth was estimated at 8.7% - this might be due to increased cost of medications as volume sales remained static In 2006, the pharmaceutical market totaled $10.1 billion and the medical device market totaled $1.9 billion Around 70% of Mexico’s medical device imports are from the US Public institutions account for 80% of the total medical device market

TRADE Mexico enjoys no tariffs with US, Canada under the provisions of NAFTA Additional trade agreements in place with Chile, Costa Rica, Bolivia, Columbia, Venezuela, Nicaragua, EU, Israel, Guatemala, El Salvador, Honduras and Japan These agreements have fostered rising international trade and investment Mexico represents 90% of all Latin American export capabilities. Almost all medical export are shipped to the US (‘maquilladora’ activities)

Insulin Infusion Pump An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm The infusion pump is usually used with the infusion set to form the Infusion set

Regulatory Environment Devices must be approved by Secretaria de Salud (Salud) Sale and Manufacture of medical goods are regulated under the current general health law adopted in 1992 Medical devices also covered under Health Goods Ruling and Federal Consumer Protection Law Federal Law of Metrology and Standardization Amended December 24, 1996 Amended May 20, 1997 Amended January 14,1999 Under the provisions of this law, all products must conform to all applicable standards

Regulatory Environment Secretariat of Commerce and Industrial Promotion (SECOFI) manages standardization activities NOMs (Normas Oficiales Mexicanas) Mandatory standards for the protection of consumer health and safety, commercial information, and the protection of ecology and environment Issued by Mexican Government Secretariat according to each jurisdiction Any person (national or foreign) can propose changes to the standard through SECOFI The General Directorate of Standards (DGN) is the administrative unit of SECOFI in charge of receiving these requests and initiating the process. E.g.. NOM-137-SSA1-1995(Labeling of Medical Devices) NMXs( Normas Mexicanas) Voluntary Standards Salud approvals are permanent. No renewal required

Regulatory Environment Device Classification Class I: Well-known to medical practice proven safe and effective Not introduced in human body Salud Response time: 30 working days Class II: Well-Known to Medical Practice, but have a variation of raw materials, component concentration Introduced and kept in the human body for less than 30 days Salud Response time: 35 working days Class III: New devices or recently approved in medical practice Introduced in the human body and remaining inside for more than 30 days Salud Response time: 60 working days If no response is obtained in the specified terms, requestors must understand that the registration is denied, except for "Class I" products, where requestors not receiving an answer must understand that the registration is approved

In order to participate in government bids in Mexico, registration with the Instituto Mexicano del Seguro Social (IMSS) is required The Salud approval certificate must be obtained prior to making a submission to the IMSS Only certain products can be registered with the IMSS Descriptions and specifications for these products are listed in a government book titled Cuadro Básico y Catálogo de Material de Curación y Prótesis . Products must match these specifications to be eligible for government bids An IMSS registration is more complicated and also more expensive to obtain than is a Salud registration. In addition to the registration submission, actual product samples need to be submitted IMSS

Insulin Infusion Pump Class II device The registration submission dossier has to be submitted to Salud 35 days to get a response from Salud

Regulatory Requirements Medical devices must be approved by the Secretaria de Salud (Salud). If a product line is new for TrojanCare, a full registration submission is required. If the product line has already been registered and TrojanCare wants to add new item numbers to the registration (new sizes, etc.), however, only the CFG and an original brochure are required. First Issue: TrojanCare must have an office in Mexico. OR TrojanCare must appoint a local distributor to register products on its behalf. Advantages: Language, Experience with local public, Understanding of the local regulatory scenario. Disadvantages: Only communication channel.

Registration Submission Dossier Contents of the Registration Dossier: Accurately filled application. Registration fee payment receipt. Documents pertaining to the manufacturer, and to the manufacturer’s representative/distributor in Mexico: Representative/distributor's name, address, and telephone number. Name and address of the institution/company that will prepare or store the product. Name, address (in the country of origin), telephone and fax number of the product manufacturer. Name and signature of the responsible person in Mexico. Copy of the authorization of the responsible person from the Mexican distributor/representative's office.

Registration Submission Dossier A letter addressed “To whom it may concern” naming the distributor in Mexico and granting an exclusive license for distribution of the product in Mexico. Product Information: Use or purpose. Description of product's structure, raw materials, parts and function. Manufacturing process flowchart. Technical specifications of the finished product. Procedures to evaluate it, and evaluation's results report. Certificate of Analysis (CoA): Authenticated document, issued by an accredited firm or individual, that certifies the quality and purity of a certain batch/lot of the products being exported. Product's Manual (Original and Copy in Spanish). Sterilization Parameters and test reports if applicable.

Registration Submission Dossier Proposed Labels (Original and Copy in Spanish): Commercial name of the product. Product's use and warnings. Catalog, lot or serial number. Name or business name and address of the manufacturer. Name or business name and address of the distributor. Certificates: Certificate to Foreign Government: This certificate is issued by FDA for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. Description of the packaging system and the package integrity tests. CFG and Letter of Authorization have to be authenticated.

Summary of Requirements b: plus Salud Approval Certificate Requirement Salud IMSS Certificate to foreign government (CFG) X X b Letter of authorization (for distributor) X List of materials X X List of packaging materials X X Manufacturing flow chart X Labels X Directions for use X X Performance specification X X Finished product drawing X X

Summary of Requirements Requirement Salud IMSS Sterilization parameters (If applicable) X X Sterility test report (If applicable) X Package integrity tests X Finished product quality control test methods/representative test report X Physical test methods/reports X Stability studies X Clinical publications X Samples X Product brochure X X

Summary of the Process RA representative gets the registration request RA representative Request Legalization Required documents are legalized from the Consulate RA collates the submission dossier Local Representative/Distributor submits the dossier to Salud Salud reviews the dossier Submission Cleared

Advantages Close proximity to US Large population with high incidence of DM Advanced manufacturing infrastructure – many factories are FDA-approved Compliance with GMP, established regulations, fast accrual and quality data Stronger IP protection than other Latin America countries (NAFTA, TRIPS)

Challenges Patented products are not used in public sector unless there is no “technically reasonable” alternative Manufacturer’s representative or distributor is Mexico is required for product registration. Though IP protection regulations are in place, enforcement can be difficult Expansion of health coverage will continue to provide incentives for basic, essential drugs instead of more advanced therapies

My Presentation on Mexico Medical Device Regulations

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My Presentation on Mexico Medical Device Regulations