Global Registration consulting for Medical Devices and IVDs (Device Registration)
Compliance consulting for medical device registration FOR Global Commercialization
Successfully commercializing your medical device begins with securing registration and approval from regulatory agencies in each country where you intend to market your product. However, registration requirements can differ significantly from one country to another, presenting compliance challenges for companies aiming for a multi-market strategy.
Depending on your target markets, achieving successful registration may require significant effort to fulfil premarket technical and clinical submission requirements, or you may be able to expedite your access to new markets by leveraging your existing registrations and approvals.
Medical Device Regulations and Registration by Country
MEDRA has assisted medical device and IVD companies in registering their products in over 25 countries. Our consultants offer specialized expertise in device registration and regulatory compliance across established markets such as the US, Europe, and Japan, as well as in emerging markets including China, Brazil, India, and Mexico
We support medical device companies with their registration goals in the following markets:
North American registration consulting for medical devices and IVDs
- Health Canada IVD Classification Consulting Services
- Canadian CMDR Consulting for Health Canada Medical Device Registration
- FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)
- US FDA Consulting for Medical Device and IVD Manufacturers
Latin American registration consulting for medical devices and IVDs
- ANVISA Medical Device and IVD Registration and Approval in Brazil
- INVIMA Medical Device Registration and Approval in Colombia
- Costa Rica Medical Device Registration
- COFEPRIS medical device and IVD registration and approval in MexicoMedical Device Registration in Peru
Medical Device Registration in Peru
Europe, The United Kingdom (UK) Registration for medical devices and IVDs
- Europe and CE Marking Strategy for Medical Devices
- UKCA marking Strategy for medical devicea
Asian Pacific registration consulting for medical devices and IVDs
- Medical Device Registration with the Australian TG
- China Medical Device Registration and Approval
- Medical Device and IVD Registration and Approval in Hong Kong
- India CDSCO Medical Device Registration and Regulatory Approval Process
- Medical Device Registration and Approval in Japan
- Medical Device Registration in Malaysia
- MedSafe Medical Device Registration in New Zealand
- Medical device registration for Health Sciences Authority (HSA) in Singapore
- Medical Device Registration and Approval in South Korea
- Taiwan Medical Device Registration Consulting
- Medical Device and IVD Registration and Approval in Thailand
- Medical Device and IVD Registration and Approval in Vietnam
MENA region registration consulting for medical devices and IVDs
- MMedical Device and IVD Registration and Approval in KSA (SFDA)
- Medical Device and IVD Registration and Approval in Emirates
- Medical Device and IVD Registration and Approval in Oman
- Medical Device and IVD Registration and Approval in Egypt
- Medical Device and IVD Registration and Approval in Lebanon
- Medical Device and IVD Registration and Approval in Jordan
- Medical Device and IVD Registration and Approval in KSA (SFDA) (appears twice)
- Medical Device and IVD Registration and Approval in Bahrain
- MMedical Device and IVD Registration and Approval in Tunisia
- Medical Device and IVD Registration and Approval in Algeria
- Medical Device and IVD Registration and Approval in Qatar
- Medical Device and IVD Registration and Approval in Yemen
Need help with regulatory strategy?