Bringing a new medical device to market is an exciting yet challenging process. A critical step is ensuring your device complies with regulations and is properly registered in your target markets before launch.
Medical device registration requirements vary across countries and regions but generally involve submitting specific documentation to prove your device is safe and effective.
The registration process aims to protect patient health while enabling access to innovative technologies.
While complex, proper planning and strategic considerations can streamline medical device registrations globally. This article provides an overview of key markets’ registration processes and top strategies to accelerate your regulatory submissions.
Whether entering your first market or expanding to new territories, use these tips to make your registration journey smooth and compliant.
Registration Requirements in Key Markets
Understanding the registration requirements for medical devices in key global markets is critical for market access. Here are some of the major markets and their regulations:
MDR/CDSCO (India)
- Under India’s MDR devices are classified based on risk level, and conformity assessment by recognized bodies is mandatory for registration.
- The Central Drugs Standard Control Organization (CDSCO) oversees the registration process and ensures compliance with the MDR.
- Obtaining CDSCO registration is essential for devices to be legally marketed and distributed in India’s thriving healthcare market.
- Being a pioneer in the India market, Taevas offers post-regulatory as well as distribution and marketing services amongst many other services for medical devices and IVD’s in India.
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FDA 510(k) (United States)
- The FDA 510(k) clearance is mandatory for medical devices sold in the US.
- This involves a premarket submission to demonstrate substantial equivalence to a predicate device along with registration and listing with the FDA.
- Annual establishment registration fees apply.
- Taevas can assist you in preparing your 510(k) submission and navigating the regulatory requirements for market entry as well as distribution and marketing in the US.
Launch your medical device business in thriving markets.
MDR/IVDR (Europe)
- The new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe require registration of devices in the EUDAMED database.
- MDR certification from a Notified Body is needed for most devices to obtain a CE mark and legally enter the EU market.
- Taevas can support you throughout the MDR/IVDR compliance process, ensuring smooth registration and market access in Europe.
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TGA (Australia)
- Australia’s Therapeutic Goods Administration mandates inclusion in the Australian Register of Therapeutic Goods (ARTG) for importing and supplying medical devices.
- Evidence of compliance with essential principles of safety and performance must be demonstrated.
- At Taevas, we can help you in demonstrating compliance with essential principles and navigate the TGA registration process.
Product Registration and Regulatory Compliance are our key offerings in every market
Health Canada
- Health Canada issues Medical Device Establishment Licenses and Medical Device Licenses for Class II, III, and IV devices.
- Manufacturers must comply with quality and safety requirements for approval to supply medical devices in Canada.
Leverage distributor support while launching your medical device in new markets!
At Taevas, we understand that medical device registrations worldwide can be complex, but we offer proper planning and strategic considerations to streamline the process. Our expertise extends across 19+ markets to guarantee regulation compliance on your behalf.
Our proficiency extends beyond paperwork, as we leverage our expertise in distribution and marketing to propel your medical device to new heights of success.
Let us be the catalyst for your business growth and connect with us today at contact@taevasglobal.com For more information, visit www.taevasglobal.com and explore how we can assist you in achieving regulatory compliance worldwide.
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