Global Planning

Global Regulatory Strategy

Paladin Medical® will help you think globally. If your company intends to market internationally, you need to know how your product will be regulated in these markets in order to optimize your resources. Compliance with FDA export and import regulations ensures smoother international access. Paladin Medical® assists in strategic regulatory planning and quality development planning. Knowing the global regulatory requirements and applicable conformance standards is the starting point for medical device input requirements.

We can help with:

• Global product requirements
• Exporting to regulated nations
• Import requirements for devices made outside the USA
• Applications to Competent Authority for Class I products
• Technical Construction Files and Design Dossiers
• European product requirements
• Canadian, European, Australian, Latin American, and Japanese submissions, among others

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International Submissions:

We guide you in the preparation of your submissions to regulatory agencies outside the USA and work with your Notified Body if you are seeking the CE Mark. Although there are common elements for most submissions each jurisdiction can have different requirements and interpretations of how standards are applied. We can author these documents and prepare your submission, collaborating with your Foreign Representative or on-site regulatory agents. Paladin Medical® helps you integrate your Design History File with the Design Dossier and your product Device Master Record with the Technical File contents. Companies based outside the USA will find Paladin Medical® can optimize your current documentation into an FDA submission. We serve as the US Agent for clients and help with compliance with regulations such as MDR reporting, recalls, and quality systems. Looking to import to the USA? Companies based outside the USA will find Paladin Medical® can often optimize current regulatory documentation into an FDA submission when needed. We also serve as the US Agent and help with compliance with regulations such as MDR reporting, recalls, and quality systems (CFR 820). Paladin Medical® can also troubleshoot if your import is held in Customs! Read more in US Agent for Medical Device.
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U.S Agent for Medical Device

Paladin Medical®, Inc. may serve as the U.S. Agent for clients with foreign establishments engaged in the manufacture of a medical device imported into the United States. FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. We also serve as liaison should there be a need for recall or corrective actions. We are on the look-out for any new guidance documents or regulations that may affect your products. Although the FDA does not require the U.S. agent to be responsible for Medical Device Reporting regulation (21 CFR Part 803), we can provide advice to your team, including template in-house procedures and guidance to help assure compliance with these requirements.
As a U.S. Agent we provide the required services:

• assisting FDA in communications with the foreign establishment
• responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
• assisting FDA in scheduling inspections of the foreign establishment
• serve as liaison if FDA is unable to contact the foreign establishment directly or expeditiously.
• assist in registration and listing via FURLs.

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