In today’s ever-evolving regulatory environment, achieving and maintaining market access for a new medical technology is a key strategic decision for manufacturers. Innovative medical products require innovative strategies to obtain regulatory clearance and maintain post-approval compliance in a complex global market. Our team is actively engaged with research pipelines and industry trends across a host of therapeutic specializations, making it possible for us to stay ahead of upcoming regulatory changes and anticipate your needs going forward.

Avania’s regional experts will partner with you to meet your specific business objectives. Whether you’re looking to enter a new market, stay compliant post- approval, evaluate transition plans from Medical Device Directive (MDD) to Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), or expand on indications, we have efficient and effective strategies to support your product’s entire life cycle.

What’s Your Strategy?

Developing a regulatory program starts with questions — a lot of questions. The answers to these questions inform your regulatory strategy, which is your guiding light to the finish lines of submission and approval:

  • What is the most appropriate path to market? Is there more than one to choose from for the product?
  • What is the product classification?
  • How will the product be regulated?
  • What are the preclinical test requirements?
  • What standards will the product be evaluated against?
  • What are the quality system requirements?
  • Will this product need a clinical study?
  • How can existing data be utilized to accelerate clinical development and achieve market access in new target regions?
  • What are the post-market considerations?

Avania shapes these answers into a sound strategy using comprehensive regulatory assessments shaped by your technology and possible product indications. We advise clients on all aspects of regulation in the U.S., Canada, EU, Australia, New Zealand, and Asia-Pacific.

Our Regulatory Services

From start to finish, your MedTech product has a long journey ahead. Each stage of development brings its own set of obstacles, and Avania’s guidance will help you overcome each of them in turn throughout the entire life cycle of the product:

  • Global Regulatory Strategies (U.S., EU, U.K., Australia, New Zealand, and Asia-Pacific)
  • Global Market Access Consulting
  • New Product Development
  • Regulatory Submissions
  • EU MDR Implementation
  • EU IVDR Implementation
  • Food and Drug Administration (FDA) Strategy and Submissions
  • MDR Clinical Evaluation Solutions
    • Clinical Evaluation Plans (CEPs)Clinical Evaluation Reports (CERs)Post-Market Surveillance (PMS) plans/reportsPost-Market Clinical Follow-up (PMCF) plans/reportsPMCF user feedback surveysRisk management
    • Labeling
  • IVDR Performance Evaluation Solutions
    • Performance Evaluation Plans (PEPs)
    • Performance Evaluation Reports (PERs)
    • PMS plans
    • PMPF plans
    • Risk management
    • Labeling
  • Market expansion and international registration
  • Management of product complaints
  • Corrective action and product recalls

Avania can offer your product development a boost from the very beginning, utilizing pre-market data and proven preparation to speed up every step of the process.

Uncover every component of Avania’s industry-leading assistance — from start to finish!

  • Expert guidance on your product’s indications under MDR/IVDR
  • Insight into the strict MDR stance on product equivalency
  • Industry-leading professionals staying abreast of the latest changes to the requirements
  • Strategy and planning for product registration and market access
  • Experienced team with broad, in-depth knowledge of FDA requirements and procedures
  • Well-designed regulatory strategy tailored to your product
  • Strategy and planning for product registration and market access
  • In-depth knowledge on how to take advantage of clinical evidence collected outside of the EU to obtain market approval
  • Transitioning from MDD to compliance with MDR
  • Customized strategies to obtain Conformitè Europëenne (CE) marks
    • Assistance with notified body selection and negotiations
    • Experts to design and control CE marking studies to meet the demands of notified bodies
  • Teams established in Europe with ISO 9001- and ISO 13485-certified standard operating procedures that comply with ISO 14155
  • Experienced team with broad, in-depth knowledge of the Australian Therapeutic Goods Administration (TGA) and private reimbursement requirements and processes, including conformity assessment applications, post-market recall, and adverse event notifications
  • Expertly designed regulatory strategies for the Australian market tailored to your device using alternative conformity paths such as MDSAP/510(k)
  • Act as local sponsor of your IVDs & devices while you arrange for an Australian distributor
  • Developed for turnkey use or through working partnership
  • Strategic planning and overall regulatory guidance
  • Interactions with reviewing divisions of the FDA and competent authorities
  • Interpretation of regulations, standards, and guidelines
  • Development of bench testing protocols
  • Development of biocompatibility test strategies
  • Interactions with test houses
  • Validation testing guidance and interface (electrical testing, packaging, sterilization, etc.)
  • Development of animal study designs/protocols
  • Interface with Good Lab Practices (GLP) animal facilities
  • Proven track record of successful ethics committee (EC) and institutional review board (IRB) submissions
  • Experience conducting multicenter trials in Europe, U.K., the Americas, Australia, New Zealand, Asia-Pacific, and the Middle East
  • U.S. regulatory submissions
    • Pre-market notifications — 510(k)
    • Pre-market approval applications (PMAs)
    • Advisory committee preparations
    • 513(g) request for designation
    • Investigational device exemptions (IDEs)
    • Humanitarian device exemptions (HUDs/HDEs)
    • E-copy format for U.S. device applications to be filed with the FDA’s
    • Center for Devices and Radiological Health (CDRH)
    • E-copy format for U.S. device applications to be filed with the FDA’s Center for Devices and Radiological Health (CDRH)
  • EU regulatory submissions
    • Expertise to lead you through national competent authority submissions
    • Technical file, design dossier, and CE mark documents gap assessment and development, including clinical evaluation plan, clinical evaluation report, PMCF plan, PMCF report, and summary of safety and clinical performance
    • Notified body selection
    • Notified body submissions and interaction
  • Australian Regulatory submissions
    • Regulatory strategy proposals using CE Mark or Medical Device Single Audit Program (MDSAP)/510(k)/PMA approvals for abridged registration process in Australia
    • Providing interim sponsorship access to Australian market for international companies until setup of TGA e-business service access for local new clients including preparation of new client ID forms
    • Lodgment of manufacturer’s evidence and ongoing certificate updates
    • Recommending relevant Global Medical Device Nomenclature (GMDN) codes and verifying Australian classification for your product
    • Preparation and submission of medical device and in vitro device (IVD)/diagnostics applications
    • Preparation of Level 1 and Level 2 application audit submissions to the TGA
    • Preparation and collation of full conformity assessment applications and device dossiers if full conformity assessment is required
    • Preparation of manufacturer’s declaration of conformity
    • Australian Register of Therapeutic Goods (ARTG) Device change requests
    • Preparation and submission of annual reports for Class IIb and Class III medical devices
    • Assisting with supply of unapproved therapeutic goods via the TGA’s Special Access Scheme and/or Authorized Prescriber Program
    • E-business notification and coordination of device recall actions and overall management of communications with the TGA’s recalls section
    • Electronic submission of incident reports for adverse events
    • Coordination and preparation of formal responses to the TGA’s post-market surveillance section regarding technical enquiries on included devices’ technical file and/or compliance to Australian essential principles
    • Sponsor and Web Assisted Notification of Devices (WAND) listings to Medsafe in New Zealand
    • Support client acquisition regulatory (i.e., due diligence and ARTG) transfers for local sponsors only
  • International design dossiers
    • Health Canada applications
    • Local teams with in-depth knowledge of your target country’s national requirements, guidelines, and timelines
    • Latin America applications
    • Expertise to lead you through national competent authority submissions
  • Preemptive guidance on the PMCF format best suited to your post-market requirements
  • Planning and executing any extensions of your product’s indications
  • Specialized support in targeted clinical investigations, case series reports, PMCF surveys, and post-market literature review
  • Summaries of safety and clinical performance
  • PMCF plans and reports
  • Warning letter mitigation and resolution
  • Medical device reporting (U.S., EU, Canada, Australia) and complaint handling
  • Safety and post-market surveillance (PMS) reporting
  • Comprehensive, well-designed PMCF studies to optimize your product’s potential
  • Expert design, conduct, analysis, and reporting for PMCF studies
  • Results that strengthen your marketing and sales efforts through increased scientific credibility and product exposure
  • Guidance for the entire regulatory process
  • Experience working closely with EU notified bodies
  • Assistance with all regulatory discussions
  • Vigilance for evolving regulatory requirements by country and region
  • Pre-market and post-market assistance
  • Tracking/trending product complaints
  • Complaint reporting to regulatory bodies (U.S., EU, Canada, New Zealand, and Australia)
  • Metrics for management reviews
  • Assistance executing the prescribed field action strategy, including product recall
  • Facilitation of necessary initial, follow-up, and closure reports to regulatory bodies (U.S., EU, Canada, New Zealand, and Australia)
  • Timely and compliant reporting
  • Assistance in developing appropriate Corrective and Preventative Actions (CAPAs) required by your quality system