The Medical Devices Introductory Course 2020

Key Requirements – Market Authorization Applications / Submissions Risk Class  Market  Low Risk: Class I Low-Medium Risk: Class II / Class IIa Medium-High Risk: Class III / Class IIb High Risk: Class IV / Class III

Brazil

“Cadastre” Class I and II submission (online notification, with less information required; 3-10m approval process)

“Registro” Class III and IV submission (full pre-market approval dossier submission with technical and clinical data and Brazilian GMP precertification required; 18-60m approval process)

Canada

MD Establishment License required (basic product family / group details; 2-4m approval; CDN $8K annual fee) Notification submission required (includes quite detailed information; 6-12m approval) Self-certification (no submission required, hold technical documents on file and notify product family to Competent Authority)

MD License required (per product, including MDSAP

MD License required (per product, including MDSAP

MD License required (per product, including MDSAP certification, IFU, DoC, more detailed premarket approval process; 3-6m approval; CDN $12K fee) Similar to Class II process, requiring classification, laboratory type testing, clinical trial in China and extensive data; 12-36+m approval) Technical Documentation pre- approval submission required (significant documentation requirements, including clinical trial if cannot duly justify otherwise; 3-12m approval) “Shonin” premarket approval by PMDA (including QMS audit by PMDA or MDSAP certification; 8- 24m approval process; ¥1-10MM fees) “Pre Market Approval (PMA)” application (includes significant technical, manufacturing, preclinical and clinical data; 6-18m approval; $341K fee)

certification, IFU, Declaration of Conformity (DoC); 1m approval; < CDN $1K fee)

certification, IFU, DoC, detailed premarket review document; 3- 6m approval; CDN $5K fee)

China

Class II: Registration application required (after classification, submit product sample for testing at government laboratory, then file registration application and conduct clinical trial (if cannot justify not needed; 12-36m approval process)

EU

Hold technical documentation on file for review by Notified Body (detailed information, also quality system audits; 3-6m approval) “Ninsho” premarket certification required from Registered Certification Body (3-6m) or “Shonin” premarket approval by PMDA (8-16m)

As for Class IIa (including clinical evaluation report and clinical trial for implants if not duly justified otherwise; 3-6m approval) “Shonin” premarket approval by PMDA (including QMS audit by PMDA or MDSAP certification; 8-18m approval process; ¥1-7MM fees)

Japan

“Todokede” premarket notification submission (no approval required)

US

“Exempt” devices (only require Establishment License and Device Listing ; $5K annual fee) or “510(k)” or “de novo” as for Class II

“510(k) premarket notification” (demonstrating substantial equivalence to a predicate device; 3-12m clearance; $12K fee) or “de novo” classification application (where no predicate exists; 1- 24m approval; $102K fee) or “Exempt” as for Class I devices

Medical Device Regulation – Rest of the World

Filing Requirements: • Vary by market:

– Scientific / technical data applications – Simple administrative applications (certification-based) • Often dependent on EU / US Registration status • CE Mark / ISO 13485 certification / FDA clearance can assist significantly in most markets • Certificate of Free Sale / Certificate of Foreign Government / Letter of Authority (all suitably notarised, authenticated and/or apostilled) • Some Key Watch Outs: – Owner v. Holder of licences; local agent / distributor requirements ( c.f. Authorised EU Rep) – may restrict who you can work with in the market – Changes (even minor ones) can have an impact on existing registrations requiring full or partial re-registration – may raise supply chain / stock out issues or need to retain old, additional sku ’ s for specific markets – Label changes (visible changes) may impact customs clearance • Example = Taiwan: make sure you spell everything correctly – customs / import – export documentation must match label addresses, including correct punctuation! – Changes in legal entities / ownership (affecting Letters of Authority, eg, may impact and require re-registrations