Unlocking Success: Navigating Medical Device Registration and Medical Device Market in Uruguay

Regulatory Authority

Ministerio de Salud Publica

The Permanent Legislative Commission, in exercise of the powers conferred upon it, decrees Law No. 9,202 creating the Ministry or “Organic Law of Public Health” promulgated on January 12, 1934, establishing health police powers, organization system, regime for its officials, free services for cases of notorious poverty, closure of establishments due to unsanitary conditions; qualification of titles for the practice of professions linked to medicine, dentistry, pharmacist; The Ministry of Public Health and Social Service is created.

Link for Regulatory Authority

https://www.gub.uy/ministerio-salud-publica/

Local Regulation

Mercosur resolutions and MSP regulations

https://www.impo.com.uy/bases/decretos/3-2008

Classification of Medical Devices

• Class I
• Class II
• Class III
• Class IV

Listing or Registration Requirements

1. 1. Uruguay is a part of MERCOSUR (Common Southern Market), which also includes Argentina, Brazil, Paraguay, Venezuela, and Bolivia. Mercosur defines Technical Regulation for medical device registration. Uruguay’s regulations are harmonized.
   2. Applicant must appoint an Authorized Representative (AR) in Uruguay.
   3. All manufacturers, importers, distributors, or their AR must register with MSP.
   4. Device are required to meet quality assurances and may be audited by MSP.

Documents Required for Uruguay Medical Device Registration

• Certificate of Free Sale (CFS) from the product’s country of origin                                                                                                        
• Detailed technical information for the device

1. proof of authorization and registration of the company;
2. technical specifications of the product to be registered, as established in this regulation;
3. documentation that is attached to the product at the time of its marketing (brochures, instructions, user manuals, guarantees);
4. certificate of free sale issued by the competent body of the country of origin. In the event that the authorities of the country of origin do no tissue and if the Ministry of Public Health deems it pertinent, may be replaced by a quality certificate issued by organizations recognized;

1. e) in the case of nationally manufactured products, the submission to registry will mean a request for authorization of sale, which will be governed by the same rules as those in force for the imported products, except as established in the literal former;

1. f) sworn statement, certifying that the medical equipment is new, used or recycled, with mention of the year of manufacture. medical equipment used must be accompanied by the recycling protocol provided to them will be made locally and a copy of the free sale certificate issued in the country of origin, with a date equal to or after the manufacture of the equipment. It must also be accompanied by a user manual, a list of service manuals available to the company that registers it, an affidavit from the company representative that includes the recycling protocol and detailing the capabilities to carry out recycling, pre-installation, installation, and after-sales service of the equipment that is registered. In case of recycling of medical equipment, the company must operate with a system of management with process traceability. Providers who have equipment with expired registrations may renew the registrations only once, if said equipment is operational.

1. g) registration applications must be signed by the legal representative of the Company and its Technical Director
2. h) any modification made by the manufacturer or importer, must be communicated to the competent health authority, for the purposes of the modification of the registry

Registration Timeline

The registration process takes 4-6 months. Can go to 10-12 months in case of higher-class devices

Registration Fee

USD $1,200

License Validity

5 years

Special Labelling Requirements

Documentation and labelling must be submitted in Spanish.

Medical Device Market

• Market depends on imports (around £106m in 2021)
• 95% of purchases made by the private sector, 5% by the public sector
• Significant investments are needed in primary care, home care and telehealth
• Main medical devices import in 2021:
  • Instruments and appliances used in medical, surgical, dental, or veterinary sciences
  • Orthopaedic appliances
  • Machinery, plant (not domestic), or laboratory equipment
  • Mechano-therapy, massage appliances
  • X-ray, alpha, beta, gamma radiation apparatus
  • Furniture; medical, surgical, dental, or veterinary
  • Sanitary ware and parts thereof, of iron or steel
• In 2022, U.S. products accounted for 32.5 percent of medical equipment imports in Uruguay, followed by China (11 percent) and Germany (9.7 percent). 
• Opportunities on medical devices market in Uruguay
  • Intravenous transfusion/infusion devices
  • Needles and syringes
  • Electro diagnostic and scintigraphy devices
  • Ophthalmology devices
  • Orthopaedic items
  • Implant and pacemakers and prosthesis
  • Global providers of R&D or manufacturing services

Branded or high R&D content manufactures

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk