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.

Overview-Regulatory Affairs 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)