Medical Device Combination Products

The market for combination products, which are pivotal in modern healthcare innovation, is a thriving one. Freyr offers tailored Regulatory solutions to help you navigate the complexities of medical device combination product registrations, ensuring efficient market entry.

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Medical Device Combination Products Overview

In the dynamic world of healthcare and innovation, medical device combination products have become a robust bridge connecting pharmaceuticals, medical devices, and biologics. The combination products market is on a fast track, with an anticipated Compound Annual Growth Rate (CAGR) of 8.9%, from 2023 to 2030. The drug-device combination products sector is poised for sustained growth, buoyed by technological advancements, improved healthcare infrastructure, smoother Regulatory routes, strategic collaborations, and a commitment to patient-centric care.

Different Types of Combination Products


Global Regulatory Scenario for the Combination Products Registration

The interpretation of what constitutes a combination product can differ from one nation to another, compounding the complexities of registering such products in various countries. Furthermore, the Regulatory demands and procedures for combination products may exhibit variations in documentation, communication, and validation. The Regulatory landscape for registering combination products can differ significantly worldwide. Here are the key Regulatory Authorities who are globally overseeing these devices.

CountryAgencyLead Centers for Approval
USAOffice of Combination Products (OCP)Center of Drug Evaluation and Research (CDER)
Center of Biologics Evaluation and Research (CBER)
Center of Devices and Radiological Health (CDRH)
EUNotified Bodies (NBs)National Competent Authority  (medicinal products)
Notified Bodies (NBs) (medical devices)
JapanEvaluation and Licensing Division or the Office of Medical Device/Cellular and Tissue-based Products of the Pharmaceutical and Food Safety BureauDirector of Evaluation and Licensing Division (DMDL), Pharmaceutical and Food Safety Bureau, Pharmaceutical and Medical Safety Bureau, Ministry of Health, and Welfare
ChinaCenter for Medical Device Standardization Administration (CMDSA)Center of Medical Device Evaluation (CMDE)
Center of Drug Evaluation (CDE)
MalaysiaNational Pharmaceutical Regulatory AgencyNational Pharmaceutical Regulatory Agency (NPRA)
Medical Device Agency

 

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

  • Assessing whether a specific device meets the criteria for classification as a combination product.
  • 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 (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 combination product.
  • Regulatory support for product development documents such as Design History Files (DHFs).
  • QMS compliance strategy. 
  • Regulatory compliance, gap analysis, and remediation of technical documents and quality systems.
  • 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 IVDs.
  • 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.