Medical Device Registration

The global medical device market is projected to grow significantly, driving manufacturers to seek effective Regulatory strategies for market entry. Freyr offers comprehensive Regulatory Affairs consulting, specializing in medical device registration and more.


Medical Device Registration - Overview

In the ever-changing landscape of healthcare technology, medical devices play a crucial role in enhancing patient care, diagnostics, and treatment outcomes. The global medical devices market is anticipated to expand from USD 536.12 billion in 2023 to USD 799.67 billion by 2030, with a projected Compound Annual Growth Rate (CAGR) of 5.5%. This growth is driven by the growing number of inpatient admissions, increased surgical and diagnostic procedures, and the rising demand for medical devices in both developed and emerging markets. The leading industry players are also increasing their research and development investments to create advanced equipment that meets the demand for innovation, further boosting the market share.

Global Regulatory Scenario for Medical Device Registration

Medical device regulations vary by country, making it essential for manufacturers to understand and navigate these differences to enter the global markets. Efforts to harmonize regulations and promote international collaboration aim to simplify this process and improve patient safety on a global scale. Each country has its own unique set of regulations and requirements, which are influenced by factors such as risk levels, product claims, and intended use. Some of the prominent guidelines available for medical device registration globally include the FDA (United States), ISO standards, Global Harmonization Task Force (GHTF), World Health Organization (WHO), and the European Union (EU). They also need to be prepared to renew their registration annually and comply with the Regulatory Authorities' expectations.

Registering medical devices in the international markets necessitates a tailored approach, involving close collaboration with the relevant Health Agencies for approval. The typical process for medical device registration involves the following steps:

  • Assessing whether a specific device meets the criteria for classification as a medical device.
  • Categorizing devices based on the associated risks.
  • Identifying the relevant standards and data prerequisites specified by the respective Health Agency.
  • Generating the necessary data as mandated by the Agency.
  • Compiling a technical file in accordance with the specific requirements of each country.
  • Submitting the application and addressing any queries or concerns until approval is obtained.
  • Managing the device's lifecycle post-approval.

Our Competencies

  • Initial risk analysis
  • Market research - Product-specific market insights
  • Staff augmentation
  • Draft Regulatory strategy
  • Potential markets and routes
  • Design file and risk analysis
  • Quality Management System (QMS) ISO 13485
  • Medical Device Single Audit Program (MDSAP)
  • QMS ISO 13485 pre-assessment
  • Regulatory strategy
  • Freyr IMPACT (Regulatory Intelligence Platform)
  • Design verification and validation
  • Risk management
  • Draft technical documentation
  • Regulatory strategy
  • Regulatory requirements
  • Freyr rDMS tool (Data/Documentation Management System)
  • Process and clinical validation
  • Final labeling and artwork
  • In-country representation
  • Regulatory submission
  • The European Union (EU) Conformité Européenne" (CE) marking and UK Conformity Assessment (UKCA) marking
  • Global market access certification
  • Notified Body (NB)/Approved Body audit support
  • In-country representation
  • Regulatory approvals
  • Post-market Surveillance (PMS)
  • Post-market Clinical Follow-up (PMCF)
  • Annual maintenance of technical file (Clinical Evaluation Report (CER)/Risk Management)
  • Regulatory renewals
  • New market launches
  • Competent Authority/Notified/Approved Body communication
  • Automated Pharmacovigilance (PV) solutions

Why Freyr?

Medical Device Registration

  • Comprehensive Regulatory strategy for medical devices.
  • QMS compliance strategy. 
  • Regulatory compliance, gap analysis, and remediation of technical documents and quality systems.
  • Regulatory support for product development documents such as Design History Files (DHFs).
  • Regulatory labeling and technical writing services.
  • Regulatory and market intelligence services.
  • Document and labeling translation services.
  • Health Agency liaising and service.
  • Regulatory artwork services.
  • Pharmacovigilance and PMS services.
  • Publishing services.
  • Medical writing services.
  • Successful submissions for various classes of medical devices.
  • Dedicated and expert personnel to provide medical device and IVD Regulatory support.
  • On-time submission of deliverables.
  • Local affiliate access to meet the challenges of the Authority and language-specific requirements.
  • In-country or legal representative support with a cost-effective model.
  • Regulatory resource management/Staff augmentation services.