Developing a sound Regulatory strategy, an in-depth understanding of country or region-specific Regulatory requirements for specific product categories, along with accurate interpretations, implications, and applicability of such regulations, are instrumental in achieving a global outreach for medical products. Whether the product is a medical device, diagnostics, biologics, or a pharmaceutical drug, a careful consideration of the Regulatory strategy early on is crucial for securing timely clearances or approvals. ACL Digital’s Regulatory services include expert consultation in building a robust global Regulatory strategy, support in executing the strategy, which can range from early engagement with Health Authorities, agencies or Notified Bodies to Regulatory filings and response to RFIs.

Regulatory and Medical Writing

Regulatory Information Management (RIMS) and Tracking of Global Regulatory Submission

  • Submission Compilation: Identify and organize the content to be used in the submissions to support global product Registrations, Filings for investigational and market approvals.
  • Submission Management: Manage Registration timelines, milestones, resources for Regulatory Operations and submission publishing partners; collaborate with various internal and external stakeholders.

Regulatory Strategy and Planning

  • Product Risk Classification and country or region-specific Regulatory Strategy for an IVD or a Medical Device

  • Regulatory Plan

International Medical Device and IVD Registration

  • EU, Health Canada, TGA (Australia)

Compliance to New Regulations: EU MDR 2017/745 and EU IVDR 2017/746

  • Gap Assessment of existing Technical Files against GSPR (General Safety and Performance Requirements), as stated in Annex I of MDR and IVDR
  • Updating Technical Documentation in compliance with Annex II and III of MDR and IVDR
  • Medical Writing: Medical Literature Search; Clinical Evaluation Reports (as per MEDEV 2.7.1 Rev 4) for Class I, IIa, IIb and III Medical Devices, other Reports needed to compile the entire Technical File/Design Dossier
  • Data structure and organization in compliance with EUDAMED requirements

Regulatory Submissions (including Amendments and Supplements, response to RFIs)

  • Review of source data, objective evidences and supporting documents
  • Medical Writing – clinical and other reports
  • Content management, compilation and packaging for final submission

 

 

FDA Filings prior to clearance or approval

  • Pre-Subs (or Q-Sub)
  • IDEs 
  • INDs (also includes IND Protocol Amendments, IND Annual Reports) 

CE-Marking (as per EU MDD and EU IVDD)

  • Technical Files and Design Dossiers for all classes of products marketed in the EU

FDA Marketing Authorizations

  • Traditional 510(k), Special 510(k), Abbreviated 510(k)
  • De Novo Classification request and De Novo submission
  • Traditional and Modular PMA, including SSED (Summary of Safety and Effectiveness Data) 
  • Emergency Use Authorization (EUA)
  • Biologics License Application (BLA) for Blood-based products, including Donor Screening Assays for Infectious Agents, in a Common Technical Document (CTD) format

Post Approval Filings (FDA and EU)

  • PMA Supplements 
  • Annual Reports
  • Post-Market Surveillance (PMS) related reports: PMS Report, PSUR, Post-Market Clinical Follow-Up (PMCF) Report, Post-Market Performance Follow-up (PMPF) Report, Summary of Safety and Clinical Performance (SSCP)