Navigating US Health Product Compliance, as a UK Company Trading Abroad

UK health product manufacturers looking to sell their products into the US will need to be aware of FDA regulations and how to stay compliant with relevant international standards. Compliance is essential if you are to ensure product safety and efficacy, understand the risks of US-UK trading, and protect your company from the potential financial or legal ramifications of misselling.

While you may be fully aware of UK health product compliance regulations, FDA regulations vary significantly, and are in many ways more stringent. Key variances in US and UK regulatory requirements can impact product development, marketing, and distribution, so it is absolutely vital that you are aware of all regulatory differences before attempting to sell into the US.

Of course, there are other important considerations for UK health product companies looking to sell into the US. You will need to demonstrate compliance with overarching international trade laws set by the World Trade Organisation (WTO), other international trade laws that apply to your specific circumstances, the Foreign Corrupt Practices Act, and US customs regulations, as well as General Data Protection Regulations (GDPR) and anti-bribery and corruption laws.

If this sounds a little overwhelming, it’s a good idea to seek expert support from clearBorder’s international trade consultants. 

We provide reliable and comprehensive trade and customs consultancy services that support you as a UK healthcare product manufacturer in selling your products internationally. We will help you navigate the many legal considerations for UK manufacturers selling into the US, equipping you to trade with ease. Simply get in touch today to discuss your specific goals and requirements.

US Health Product Regulatory Compliance: Understanding FDA Regulations

In the US, the FDA regulates all health products and provides a legal framework for international healthcare companies trading in pharmaceuticals, medical devices, and biologics.

It is vital for UK healthcare companies exporting into the US to ensure compliance with FDA guidelines and regulations, which are stricter than those upheld by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Adapting to FDA regulations can be difficult for UK companies – ensuring product regulatory compliance may require you to make changes to product development, marketing, labelling, and distribution. However, having a strong grasp of the legal challenges and requirements will help you be successful in your ambitions for international commerce.

FDA Regulations: Key FDA Regulations That Apply to International Sellers

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. The FDA provides a clear legal framework in which you are to operate when conducting international commerce with the US as a UK agent.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. It is important to know which class your medical device falls into, as regulatory requirements vary significantly between classes. The FDA provides a description of device classification and a link to the Product Classification Database, which you can view here: Classification of Medical Devices.

Depending on whether your device is class I, II or III, you may or may not be required to provide Premarket Notification 510(K), or even to gain Premarket Approval. Regardless of your device classification, the basic regulatory requirements that manufacturers of medical devices being sold into the US must follow are complex, and seeking advice on how to ensure compliance is recommended for pharmaceutical companies trading across borders.

Basic FDA regulatory requirements for the sale of medical devices include:

• Registration of establishment: Both domestic and foreign manufacturers of medical devices being sold in the US need to register their establishments with the FDA by submitting evidence electronically. You will need to verify your registration annually, between October 1st and December 31st of each year. There will be an establishment registration fee to pay.
• Designation of a U.S. Agent for distribution of your health products: Any foreign pharmaceutical companies manufacturing, preparing, selling or processing a medical device that is imported into the US must identify a U.S. Agent for the establishment. They must either reside in the U.S. or maintain a place of business in the U.S. and be available to answer the phone or have an employee available to answer the phone during normal business hours. They will be expected to assist the FDA in communications with you, respond to questions from the FDA about your devices, assist in the scheduling of FDA inspections, and provide any required evidence of compliance.
  
  You can submit information about your designated U.S. Agent electronically using the FDA United Registration and Listing System (FURLS) and you can only designate one agent, who can also be set as your official correspondent if you so wish. There will be an automated process that your designated U.S. agent has to follow in order to confirm that they have agreed to act as your U.S. Agent.
• Medical device listing: You will need to list the medical devices you are marketing with the FDA so that they can be added to the appropriate medical device databases, which include the 510(k) Premarket Notification, the Device Registration and Listing Database, and the MAUDE (Manufacturer and User Facility Device Experience) database.
  
  In order to list your device, you will need to provide comprehensive information about the manufacturer, packagers, labelers, developers, processors, accessories, and components. This is done electronically, and information about how to do so is provided on the FDA website.

Additional FDA Regulatory Requirements That May Apply

Most Class I devices and some Class II devices are exempt from Premarket Notification 510(k), which is an essential step in ensuring compliance if your device falls into the relevant Class II or any Class III bracket. If this is the case, you must receive a letter of substantial equivalence from the FDA authorising you to sell in the US before commercially distributing the device in the US.

Depending on the class of your medical device, you may be subject to Premarket Approval (PMA) – this is an essential step designed to ensure consumer safety and protect the public from potentially harmful, non-compliant medical devices or products. It is only applicable to Class III devices that are considered high risk and pose a significant risk of illness or injury.

In order to gain Premarket Approval you will need to submit clinical data to support claims made for the device. This can be sent electronically using the CDRH Customer Collaboration Portal.

If you aren’t sure whether your medical device would be considered a Class III device, you can review the Product Classification Database to help you determine this.

Applying For FDA Exemption

If your device is classified as an investigational device, you may be able to receive an investigational device exemption (IDE) in order for your device to be used in a clinical study that will be used to support a Premarket Approval application or Premarket Notification submission to the FDA. 

To qualify for exemption, you will need your study to be determined as one of nonsignificant risk and approved by the IRB before it begins. The requirements for proof of exemption are stringent, in order to prevent false claims and ensure that guidance is followed by medical device businesses.

International Trade Considerations

Understanding International Trade Laws and Their Impact on Health Product Compliance

As well as FDA approval, UK health device manufacturers exporting into the US are also subject to international trade laws that affect health product exports, such as the World Trade Organization (WTO) agreement. There are plenty of legal considerations for UK companies trading into the US, and the complexities can be tricky to navigate.

UK companies must comply with WTO regulations, including tariffs, quotas, and customs procedures. These international trade and tariff regulations help ensure that health-related products and technologies are safe and accessible across the global network. Licences, regulations and import formalities across foreign jurisdictions as well as UK government policies on export will all play a part in determining how WTO regulations affect you as an international seller.

Ultimately, good understanding of international trade laws can help UK companies navigate the US market, and protect their foreign interests by operating in a fully compliant manner.

Leveraging Free Trade Agreements for Health Product Export

Free trade agreements, such as the US-UK Free Trade Agreement, can facilitate health product exports by providing UK companies with reduced tariffs, simplified customs procedures, and increased market access.

Leveraging free trade agreements can enhance your company’s competitiveness in the US market. We recommend working with an expert international trade consultant like clearBorder to help you understand the benefits of free trade agreements, reduce risk and exploit the opportunity to increase efficiency and growth under the terms of this agreement.

Complying with US Customs Regulations and Tariffs

UK companies must comply with US customs regulations, including product classification, valuation, and labelling. Understanding US tariffs and customs procedures can help you avoid delays and penalties.

Other Factors To Consider In US Product Regulatory Compliance

• Data Protection and Privacy: UK companies must ensure data protection and adhere to every relevant privacy law when securing international trade agreements, in accordance with general data protection regulations. When importing into the US, this requires compliance with GDPR regulations and US data protection and data privacy laws, such as HIPAA, and ensures that you can maintain customer trust while avoiding regulatory penalties or legal challenges.
• Anti-Bribery and Corruption Laws: The Foreign Corrupt Practices Act (FCPA) regulates bribery and corruption in international business transactions. UK companies must comply with FCPA regulations when conducting business in the US. You will need to ensure that you clearly understand FCPA requirements for UK companies before conducting business in the US, in order to avoid regulatory penalties and reputational damage.
• US Health Product Patents and Trademarks: You will need to secure patents and trademarks for any health products you import into the US. This requires you to understand and navigate US intellectual property rules and regulations. Once you have done so, you will need to enforce your IP rights and ensure compliance with international intellectual property laws across multiple jurisdictions to ensure IP protection and avoid the necessity of legal action later down the road.
• Due Diligence for International Health Product Partnerships: UK companies must conduct due diligence to help mitigate risk and ensure success in the US.
• Contract negotiation: UK companies must negotiate contracts with international health product partners. Understanding contract law, regulatory requirements, and cultural differences is essential.
• Tax Treaties and Double Taxation Avoidance for Health Product Companies: Under the terms of the US-UK double taxation agreement, you can avoid unnecessary taxation on income and protect the value of your international investments. Complying with tax regulations and international tax laws is essential, as this will help you minimise tax liabilities and ensure compliance.
• Structuring Your Business for Tax Efficiency in Health Product Exports: Your business should be structured for tax efficiency in health product exports, in order to minimise tax liabilities and ensure compliance.
• Local Labour Laws and Employment Standards for Health Product Companies: UK companies must adhere to local labour laws and employment standards in the US. These cover minimum wage, overtime, and benefits, among other elements.
• Employment regulations: US visa requirements, work permits, and general international workforce compliance all apply to UK health product companies operating in the US.

Expert Advice On Trading With US Products

UK health product companies must navigate complex regulatory environments in order to export their medical devices and products to the US, including FDA regulations and GDPR requirements.

Understanding international trade laws, intellectual property protection, and employment regulations is difficult, and requires a deep comprehension of complex legal and tax implications.

clearBorder’s specialist international trade consultants can help you navigate the complexities of trade with the US, so that you stay compliant with US regulations and international trade laws.

To reduce the risk of non-compliance, contact clearBorder today and let us help manage your cross-border operations.