Medical devices
Development, sourcing and technical documentation for class I and II devices, with regulatory compliance.
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We support brands and distributors in the development, sourcing and technical documentation of medical devices in Chile, with a focus on regulatory compliance. It is a category where traceability and the right documentation are as important as the product itself.
What we do
- Development and sourcing of class I and II devices.
- Technical and supporting documentation for compliance.
- Management of certified suppliers.
- Support in import and associated logistics.
Why ASPharma
We combine international sourcing capability with local regulatory knowledge, so the device arrives with the documentation each procedure requires. You work with a single point of contact coordinating development, documentation and logistics.
Who it is for
Importers, distributors and health-sector brands that need a technical partner for their device lines.
Free initial evaluation and a reply within 24 to 48 business hours. We tell you clearly what is feasible and which regulatory requirements apply to your case.
Documentation that backs every step
In medical devices, the right documentation is as critical as the product. We gather the technical and supporting information each class and procedure require, so import and compliance move without obstacles and you can demonstrate the conformity of your products.
We combine sourcing from certified suppliers with local regulatory knowledge, and coordinate development, documentation and logistics under a single point of contact. That reduces the risk of errors and the dead time between suppliers that don't talk to each other.
We evaluate your case with no commitment and tell you clearly what is feasible and which requirements apply, with a reply within 24 to 48 business hours.
Frequently asked questions about medical devices
We answer the most common questions about this regulated category.
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We work on development, sourcing and technical documentation of class I and II devices, with a focus on regulatory compliance. It is a category where traceability and the right documentation are as important as the product itself.
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We combine sourcing from certified suppliers with local regulatory knowledge, and coordinate development, documentation and logistics under a single point of contact. We manage suppliers and the associated import, rather than manufacturing in-house.
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We gather the technical and supporting information each class and procedure require, so import and compliance move without obstacles and you can demonstrate the conformity of your products. The right documentation is as critical as the product.
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For importers, distributors and health-sector brands that need a technical partner for their device lines. We evaluate your case with no commitment and tell you clearly what is feasible and which requirements apply, with a reply within 24 to 48 business hours.
Have a medical device project?
Tell us your case and we will give you a free evaluation within 24 to 48 business hours, with no commitment.
Request an evaluation