2 min reading time

Obtaining market access in many countries through product registration is a daunting and mostly manual experience.

I invite you to learn a better way on February 1 at our free http://medgroup.biz/mktaccess webinar.

Today, registering products is subject to local language requirements and commercial bylaws. You need to appoint a local authorized representative and few manufacturers have the resources, knowhow, or expertise required to obtain marketing licenses beyond a few major markets.

Looking for help, the industry resorts to distributors or remote third party consultants. This is bad because the license is then owned by the distributor who controls the market – not you.

In this presentation, you’ll learn about a readily available cloud-based solution to:
• Expedite product clearances;
• Process multiple registrations in multiple countries on one platform on a fixed budget;
• Keep ownership of your product; and,
• Allow in-market sales and marketing activities sooner.

The content is timely because many regulatory agencies around the world established or are implementing public health policies concerning medical device pre-market approvals. Manufacturers are placing more effort to enter new markets and industry growth relies on global markets rather than solely the traditional US, EU, and Japanese markets.

Benny Arazy will present the live http://medgroup.biz/mktaccess webinar on Wednesday, February 1 at noon New York time. It will be recorded and shared with all who register, whether you can make the live event or not.

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Discussions

Can you recommend a stable company to make injection molding forms for a medical device?

New Medical Device Regulation (EU)

“Our Leadership is Eroding”

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SUPER BOWL TIME

We’re down to four teams. Who you got?

Guess the correct Super Bowl teams and final score and win free admission to the next 10x Medical Device Conference at http://medgroup.biz/superbowl

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. See you in Orange County next Monday at Med Tech Monday: http://medgroup.biz/MedTechMonday

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Nicole De Havilland, try this link instead: https://medicaldevicesgroup.net/webinar/mktaccess/

Nicole De Havilland
Company Owner at RECO HEART LIMITED
The link doesn’t seem to work?

Ahasan Chowdhury
Chief Drug Regulatory Consultant at BSafe BD.Forever Owner & Working on Medicine ,Medical Device & IVD +8801716592577
https://www.linkedin.com/in/bsafe-bd-3236a9134/

Pernelle Kruse Schøndorff
Senior Clinical Research Specialist, Clinical Development & Regulatory Intelligence, R&D hos ConvaTec
Cindie Vandfeldt

Armin Torres
Digital Life Science Innovator@Qualified Data Systems
I find that knowing ahead of time how long the process will take for pre-market approval is a useful metric in creating a regulatory strategy around the markets targeted for access. The average time it will take for US registration can be found and calculated easily by using OPEN FDA data from the 510K database for Medical Devices as an example. That timeframe should be integrated into the product development commercialization pipeline to get a better view of time to market. Timing and access to markets are vital to sales/marketing teams. Being able to reduce that timeline should be a strategic goal.