Global Market Access Strategy
Gaining access to global markets is an important consideration for many medical device manufacturers. As technologies rapidly evolve, gaining marketing authorizations is crucial, particularly for new devices.
Navigating the maze of global requirements can be challenging. Many markets are rapidly expanding their regulatory requirements in an effort to match new medical technologies.
To meet manufacturers' competitive challenges, it is important to look strategically ar achieving regulatory approvals. Oftentimes, manufacturers can use a market clearance in one of the major marketplaces to gain market clearance in other markets.
For example, preparations of a market submission for the USA FDA will provide many of the documents needed for the technical file that is needed for the EU Medical Device Regulation Compliance (MDR).
An effective strategy must contain a number of elements, refined to the markets the company desires to enter. Qserve has been supporting Medical Device and IVD companies with regulatory compliance and market access since 1998. We have offices in Europe, the US, and China offering a wide range of compliance, quality, and clinical services.
The United States represents the largest market for medical devices. Devices that have received premarket approval (PMA),
510(k) Clearance, or DeNovo designation are likely to gain more rapid acceptance by regulatory authorities in a number of other countries.
Another benefit of gaining clearance in the U.S. is realized by the fact that once clearance is gained, it does not require renewal. Unlike some other jurisdictions, the FDA does not require companies to update their testing requirements and documentation when standards are updated, unless the company has made a significant change which requires an updated 510(k) clearance.
Our knowledge of the US FDA ensures that we can support you with a cost-effective regulatory strategy
Europe is currently the next largest economic opportunity for medical device markets. Through the CE mark, companies have access to the various countries within Europe with the one CE requirement. For Europe, a manufacturer needs to consider the consequences of compliance with the new MDR and IVDR. We are seeing companies struggle with meeting the many added requirements, including manufacturers, distributors, authorized representatives.
We are experts in European medical devices and In Vitro Diagnostics Compliance.
China's medical devices market is developing at a whirlwind pace, far outstripping the country's economic growth rate. Currently increasing in value by around 20 percent a year, putting it in second place behind the U.S.
The NMPA (formerly the China Food and Drug Administration), is the institution responsible for pharmaceuticals and medical devices regulations in China. Much like the FDA in the U.S., devices are classified according to their potential risk. The level of the clinical evaluation required depends on this classification.
With China's medical devices market growing rapidly, the associated regulatory environment is constantly evolving too. For Western manufacturers, this means navigating the market is not a straightforward proposition and demands ongoing assessment.
Qserve can help you navigate through the Chinese market by offering a wide range of customized services.
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Support for experienced or starting companies
Our customers value us for our practical approach, our international focus and or broad and specific expertise. Qserve is the one-stop partner for all compliance projects with the final goal: getting their product on the international market.
Challenges with the Notified Body, CAPA system, resources for global registration, maintenance of technical files, preparation of Clinical Evaluation Reports.
Challenges with regulatory requirements and in need of a partner that can assist with all compliance issues, from
strategy to market approval.
Lack of resources and hands-on expertise
for further product development and network for compliance with