Key entry strategies for Medical Implant Companies

With the Latin American (LA) medical device market estimated to be worth $11 billion and experiencing rapid growth, medical device companies can explore strategies to gain swift access to these markets. This involves understanding the market entry channels, processes, and typical models. Argentina, Bolivia. Brazil, Chile, Columbia, Mexico, Paraguay, Uruguay, and Venezuela are Latin American countries that have a very structured regulatory affairs system.

To expedite access to the LA markets, medical device companies can consider the following approaches:

Partnering with local distributors:

Collaborating with established distributors in the LA can provide faster market entry. These distributors often possess in-depth knowledge of the local market, established networks, and regulatory licenses required for distribution. Partnering with them allows companies to leverage their existing infrastructure and customer relationships.

Establishing a subsidiary or local presence:

Setting up a subsidiary or local office provides companies with greater control and flexibility in managing operations and distribution. It allows for direct engagement with healthcare providers, regulators, and other stakeholders. Although this approach may require more time and resources initially, it offers long-term advantages in terms of market penetration and brand building.

Engaging Authorized Representatives (ARs):

ARs are local entities that possess the necessary regulatory licenses to import and distribute medical devices. Collaborating with ARs enables companies to utilize their licenses and leverage their established networks. This approach can be particularly useful for companies seeking to test the market before committing to a subsidiary or independent distribution network.

The following are the steps that are involved in the entry strategy for the Medical devices company:-

Legal establishment
Regulatory approval for the Company
GMP certifications
Product Registration/Certification

Registration management considerations - Latin America

Distribution

Varies by Country within Region
Localized relationships necessary
Infrastructure only supports Independent Distributorships
Multiple franchise product responsibility
Ratio Management – Manage capital/inventory

Competition

Local competition knockoffs
Typically “Influential” Surgeon driven/owned
Little patent protection from Govt. – “Keep money in Country”
Ratio Management – Manage capital/inventory

There are 3 ways for the legal establishment of a Company in Latin America.

Through the establishment of a subsidiary
Through a distributor that already has the regulatory licenses
Through an Authorized Representative (AR)

Through the establishment of a subsidiary:

Establishing a subsidiary allows the Company to have registrations in its name. It provides the Company the flexibility to appoint Distributors or change Distributors anytime. On the flip side, establishing a subsidiary takes more time. The Company should first obtain the state or city regulatory license and the authorization from the federal regulatory authority before applying for product registration. For medical device Companies, the product registration timeline is between 4 to 6 months and for medical consumables and disposables, the product registration takes about 4 to 9 months.

Through a distributor that already has regulatory licenses:

This is a faster way to enter the market. If the distributor has all the regulatory licenses, this option is a much faster way to enter the market. Many distributors can have the registration of the same product. However, the licenses will be in the name of the distributor(s) and not the foreign Firm. The licenses generally cannot be transferred unless in case of incorporation, fusion or separation of Companies.

Through an Authorized Representative:

If the Authorized Representative (AR) Company has the regulatory licenses, the foreign Company can register the product in the local regulatory agency which, as already stated takes about 4 to 9 months. The foreign Company can change the distributor as necessary any time. Using the AR’s registration number, the distributor can import the products. Also, using the AR’s registration number, the holder of the product’s registration can authorize its local distributors or final consumer (Hospitals, Labs, and Clinics) the product can be imported.

Document checklist to register medical devices in Latin America

Company’s working permit
Free sales certificate (when applicable) Consularization in closest embassy/Consulate of the country where the product will be registered.
GMP certificate (when applicable)
Certificate of conformity (For electro-medical devices only)
Instructions of use, inserts, user manual
Service/installation manual
Labelling
Packing
The composition of the medical device
Basic manufacturing flowchart with operations made in each phase
Validation of sterilization protocol (when applicable)
Proofs of safety and efficacy

Additional documents required

Technical drawings of all components with the physical dimensions and tolerances;

Controls used by the manufacturer during the manufacturing phase.
All Quality Certificates obtained by the Manufacturer like ISO 9001, 13485, CE Mark, 21 CFR FDA, etc.;
All Quality Certificates obtained by the third-party companies that work for Manufacturers like ISO 9001, 13485, 21 CFR FDA, etc., when applicable
Clinical studies performed with the product itself or similar products to prove the efficacy and safety

Steps to Medical device registration

Documentation from the manufacturer
Critical analysis
Preparation of technical dossier in local language
Payment of Taxes
Submission in local regulatory authorities
Analysis by local regulatory authorities
Final approval

The typical market entry processes in Latin America include:

Regulatory compliance:

Companies must ensure their medical devices meet the regulatory requirements of each country in which they plan to operate. This involves obtaining necessary certifications, approvals, and licenses from the respective regulatory authorities. Compliance with quality standards such as Good Manufacturing Practice (GMP) and ISO certifications is often required.

Product registration:

Companies need to register their medical devices with local regulatory agencies. This process involves submitting documentation, technical dossiers, clinical data, and evidence of safety and efficacy. The registration requirements and timelines vary among countries, ranging from several months to over a year.

Distribution and sales network:

Establishing a distribution and sales network is crucial for reaching healthcare providers and end-users. This involves identifying and partnering with distributors or building an in-house sales team. Developing localized relationships and understanding the unique distribution channels within each country is essential.

Marketing and market access:

Effective marketing strategies tailored to the local market are vital for success. This includes understanding the preferences, needs, and cultural nuances of the target customer base. Engaging with key opinion leaders, participating in industry conferences, and leveraging digital marketing platforms can help create awareness and generate demand.

Conclusion

In summary, gaining fast access to the growing LA medical device markets involves partnering with local distributors, establishing a local presence, or engaging authorized representatives. Companies need to navigate the regulatory landscape, register their products, and build a strong distribution and sales network. Tailoring marketing strategies to the local market and investing in market access efforts are also crucial for success.