FDA - Regulatory Strategic Planning

  • Intended use and indications for use strategy- stepwise approach to facilitate time to market

  • Product classification & product code/s

  • Predicate devices

  • Applicable performance, safety, EMC and labeling standards & guidelines

  • Clinical/ Preclinical requirements to support the claims

  • Regulatory assessment of product changes (LTF/ 510k)

FDA- Preparation & Submission of Regulatory Binder

  • FDA Pre-Sub, Pre-market Notification- 510(k), De Novo, Pre IDE, IDE submission 

  • Interactive work and face to face meetings with FDA  

  • Establishment Registration & Device Listing

  • Product Labeling

CE Mark

  • Regulatory Strategy- Medical Device/ IVD/ Non Medical

  • Notified Body Selection

  • Product Classification

  • Interactive work with Notified Bodies, Competent Authorities  

  • EU Technical File for CE Mark

  • Clinical Evaluation Report (CER)

  • Post-market Clinical Plan 

  • Vigilance: Medical Device Reporting- MDR, FSN, FSCA, Recall

  • EU MDD, IVD Directives / MDR, IVDR Regulations: transition strategy, gap assessment, work plan and hands-on support

Design Control Activities

  • Risk Management process in accordance with ISO 14971

  • Materials compliance: RoHS, REACH, Cal Prop 65, EU MDR

  • Verification & Validation protocol and report

  • Performance bench test

  • Biocompatibility, Sterilization

  • Safety, EMC, Transportation, Service Life, Shelf Life

  • Preclinical, Clinical Studies

  • RED: Wireless directive requirements

  • Preclinical animals studies- study design, protocol & report

Global Registration

  • Canada - MDEL, MDL

  • Israel - AMAR Registration

  • Brazil - INMETRO, ANVISA

  • Japan - MHLW, PMDA, Categories: Todokede, Ninsho, Shonin

  • China - CFDA (now NMPA)

  • Other LATAM countries (Argentina, Mexico, Pero etc); other APAC countries (S Korea, Singapore, Vietnam etc) 

  • Australia - TGA

  • Middle East countries 

  • Define the specific in-country' regulatory requirements including labeling & GUI language.

  • Working directly with local authorities, distributors or Marketing Authorization Holder to register the product.

  • Preparation of Summary Technical Documentation (STED).

  • Design the clinical study when required to support local registration.

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