Unlocking Global Markets For MedTech Companies

Choosing a third party like Pure Global as your medical device regulatory in-country representative has numerous benefits:

Maintain control to your registration: In most markets, the in-country representative is the legal name on your registration. If your distributor is your representative, conflicts of interest can arise if you want to change or add distributors in that market.

Fulfill regulatory obligations: Your representative may have additional regulatory responsibilities to perform on your behalf, depending on the market. Distributors may not be informed about all the duties of an in-country representative or have the resources to perform them. Pure Global has deep experience in the regulatory requirements for all markets where we offer in-country representative services.

‍Expert regulatory guidance: Your in-country rep should guide you through the registration process, advise you on the completeness and formatting of your registration dossier, and be a proactive liaison with the local regulatory authority. It’s critical to select a regulatory expert who can advocate for your success in your target market.

Medical device compliance requirements are constantly evolving. Whether you’re preparing to enter a new market or maintaining existing authorizations, you must be proactive to stay informed of new regulatory developments. 

Medical device regulatory consultants at Pure Global actively monitor and analyze developments in 30+ markets. Here’s how you can stay up-to-date:

• Weekly Regulatory News: A round-up of essential medical device regulatory news from around the world, published every week.
• Regulatory Blog: In-depth analysis of developments from our team of regulatory consultants.
• Join our community: Get insights from our expert team delivered to your inbox and the latest news from our AI-powered regulatory update tool.

As soon as possible. Many manufacturers wait until they receive a rejection or information request from a regulatory authority to bring in a regulatory consultant. But regulatory expertise can be invaluable as early as the device design and development stages. We can help you plan for the regulatory implications of your device’s intended use and indications for use, establish a holistic QMS that satisfies multiple market requirements, identify device-specific testing needs, and acquire compelling clinical data, if required. Early regulatory planning can save you time and money long term and facilitate your device’s entry to the market.

Pure Global delivers end-to-end, on-the-ground in-country representative and medical device regulatory consulting services in the world’s biggest markets from our offices in the US, Europe, the UK, Asia, Latin America, and Australia. Through partnerships with local regulatory consulting firms, we offer extended market access to South Asia, the Middle East, Africa, and beyond.