Chile’s regulatory landscape for medical devices is evolving, and navigating it requires an understanding of the current rules as well as preparation for upcoming changes. This guide offers a comprehensive overview of the requirements for entering the Chilean market, ensuring compliance, and minimizing potential delays.
Current Regulations
In Chile, sanitary registration is currently required only for a limited range of medical devices, including:
- Latex Surgical Gloves (Single Use)
- Latex Examination Gloves
- Male and Female Condoms (Latex and Synthetic)
- Sterile Hypodermic Needles (Single Use)
- Sterile Hypodermic Syringes (Single Use)
- Automated External Defibrillators (AEDs)
- In Vitro Diagnostic Devices for HIV (Self-Test and Professional Use)
Manufacturers of products that fall outside of this limited list are not currently required to register their devices but should stay aware of changes to the regulatory framework.
Upcoming Regulatory Changes
A new law is under development that will mandate the registration of all medical devices, regardless of their category. While the exact date of enactment remains uncertain, it is expected to come into force soon. Once enacted:
- All companies marketing medical devices in Chile will need to register their products with the Ministry of Health (ISP).
- An influx of registration applications is anticipated, which could lead to delays in processing at ISP.
This anticipated backlog makes early action essential for any company wishing to enter the market or ensure their continued market presence in Chile.
Recommended Strategy for Market Entry
Given the upcoming regulatory changes, companies should consider applying for a Certification of Background Reviewwith ISP. This is an optional procedure but offers numerous advantages, especially as the new law takes effect:
What is the Certification of Background Review?
This optional procedure involves a technical, legal, and administrative evaluation of the medical device by the MOH. Although not mandatory, it provides several benefits:
- Ensures Product Quality and Safety: Demonstrates compliance with regulatory standards for both public health services and private clients.
- Competitive Market Advantage: Signals to stakeholders that the product has undergone a thorough review, boosting confidence and credibility.
- Expedited Registration: If the new law is enacted, the Certification of Background Review can potentially expedite the mandatory registration process, minimizing delays in product access.
Steps to Market a Medical Device in Chile
1. Company Registration:
Before selling medical devices, companies must be legally registered in Chile. This includes:
Registering with the Public Health Institute (ISP) for healthcare-related activities.
If a local presence is not established, partnering with a local distributor or regulatory representative is necessary.
2. Determine Product-Specific Requirements:
Identify if your product already falls under existing sanitary registration requirements.
Stay informed about the new mandatory registration law and prepare documentation accordingly.
3. Prepare Documentation:
Compile technical files, labeling, safety reports, and compliance certifications as required by the ISP.
4. Apply for Certification of Background Review(Recommended):
Submit the necessary documentation for optional certification with the MOH to ensure compliance and get ahead of regulatory changes.
5. Monitor Regulatory Updates:
Keep track of any changes to the law and submit your product for mandatory registration as soon as the new law comes into effect to avoid disruptions.
Why Early Action Matters
- Delays: Once the new registration law takes effect, delays in registration are expected due to the influx of applications. Early preparation ensures timely market access.
- Competitive Edge: A Certification of Background Review can position your product as compliant and trustworthy, offering a commercial advantage in the marketplace.
- Compliance: Registering your company or working with a trusted local partner ensures adherence to Chilean regulations, minimizing legal risks.
How LAMA Can Help
Navigating Chile’s evolving regulatory framework can be challenging, but LAMA offers tailored solutions to help you stay ahead. Our team of experts provides:
- Regulatory Insight: Stay informed about the latest changes and how they affect your products.
- Compliance Support: From company registration to document preparation, we ensure your business meets all regulatory requirements.
- Streamlined Processes: Our services include assistance with the Certification of Background Review and preparation for mandatory registrations.
Chile’s relatively simple regulatory requirements can make it appear attractive as an entry point to the Latin American market. However, companies should be cautious of the high costs associated with operations, intense competition in certain medical device sectors, and challenges in establishing and managing distribution networks. LAMA recommends leveraging the time saved on regulatory planning to focus on robust commercial planning, ensuring your business has a well-defined strategy to navigate these challenges and succeed in the Chilean market.
With LAMA by your side, you can minimize delays, secure market access, and gain a competitive edge in Chile’s growing healthcare market.
Conclusion
This guide offers practical steps for entering the Chilean medical device market and managing upcoming regulatory changes. By preparing early and pursuing a voluntary review now, companies can avoid delays, secure a smoother entry into the market, and gain a competitive edge. Taking proactive action will help ensure your business remains compliant and well-positioned in this growing healthcare market.
Contact LAMA today to learn more about how we can assist you in navigating the Chilean market and beyond.
If you’re considering expanding your brand into the LATAM market, our consultancy is here to support you every step of the way, including in the exciting realm of nanomedicine and cosmetics. Together, we can unlock the full potential of your brand in this vibrant and growing market.