Indian Certification for Medical Devices (ICMED) Scheme- Provisional Approval of CBs QUALI LITY Y COUNCIL OF IN INDIA
Key stakeholders .... National Accreditation Board for Association of Indian Certification Bodies (NABCB) Manufacturers of Medical Quality Council Devices of India NATIONAL ACCREDITATION BODY Manufacturers of Regulators Certification Bodies Users Medical Devices
Governing Structure Steering Technical Certification Committee Committee Committee • Advisory committee • Comprises of • Develops, maintains which comprises of personnel with and revamps the key stakeholders technical expertise scheme documents • Overall structure • Identifies, defines and • Develops, maintains formulation, develops criteria w.r.t and revamps as modification and its technical appropriate the supervision implementation requirements for CBs; usage of certification mark as certified • Adapts measures to • Resolves technical entities enhance scheme’s issues pertaining to acceptability and scheme’s promotion requirements 3
Why Provisional Approval is needed- CB needs to have a brief period of understanding the Scheme and the accreditation to needs to have couple of cases done before they grant certification. 4
Scheme has been Launched with Two Levels of Certification • ICMED 9000 Certification which is ISO 9001 plus Additional requirements • ICMED 13485 which is ISO 13485 plus Additional Requirements • ICMED 13485 Plus Under development
Eligibility Requirements CB shall be a Legal entity/ Governmental Certification body ICMED 9000 ICMED 13485 • Hold NABCB Accreditation for • Hold NABCB Accreditation for QMS certification as per ISO ISO 13485 certification 17021-1:2015 • Accredited for scope DL 33.1 for • IAF scope 19 covering NACE QMS as per ISO 17021:2015 (Rev 1.1) DL 33.1 • Shall have undergone a witness • Shall have undergone a witness for the first audit for ISO 13485 for scope in last 3 years 6
Application for PA - Documents to be attached Organization Registration Certificate & Memorandum / Articles of Association (copy only) Master List of Documents relating to ICMED (with issue and/or revision status) Quality Manual in accordance with ISO/IEC 17021(ICMED Related) Documentation relating to ICMED (Procedures, Competence Criteria, Formats, Checklists etc.) Branch Office(s) to be covered under approval List of Managerial Personnel & Auditors Application Fee - Amount, Cheque / DD No., Date etc. Other Documents as appropriate to Scheme 7
Approval Process of Certification Body Approval Process of CBs for ICMED Certification Submission of Application and Associated Documents by the applicant CB Formation of Assessment Team Document Assessment by Assessment Team - One Assessor for ISO Closure of NCs (if any) 17021 - One Technical Expert Onsite Office Assessment by Assessment Team Closure of NCs (if any) Submission of Report on both Review of Document and Office Assessment to QCI Closure of NCs (if any) Decision by QCI on Provisional Approval of CB Witness Assessment by QCI to Confirm One Year CB’s Competence CB must obtain NABCB Accreditation within One Year of Provisional Approval
Provisional Approval Criteria – CORE Elements (Indicative) Liability & Legal Entity Financing Competent Impartiality Resources Use of Publicly certification available mark information 9
Competence- Auditors Experience in CBs Auditors Education Manufacturing, Research & QA in Medical Device Graduate in Bio Technology, Electrical Engineering, Electronics Engineering, 2 Years Chemical Engineering, Bio Medical Engineering, Mechanical Engineering, Required Qualifications Graduate in Science 3 Years Diploma in Engineering or 4 Years Pharmacy
Audit Experience Certification Scope Training Undergone Specific Skill Set Review of Documentation Risk Management Of Medical Devices Implementation Audit Training on ICMED 9000 ICMED 9000 Audit Reporting requirements ___________________________ Two Audits (at least 10 mandays ) for accredited QMS programme Certification Scope Training Undergone Specific Skill Set Two Audits (at least 10 Training on ICMED 13485 ICMED 13485 mandays ) for requirements Accredited ISO 13485 Programme
Lead Auditor Experience Requirements Certification Scope Requirement Experience Performed as an audit team leader ICMED 9000 For ICMED 9000 Auditor for 3 ISO 9001 Audits Certification Scope Requirement Experience Performed as an audit team leader ICMED 13485 For ICMED 13485 Auditor for 3 ISO 13485 Audits
Publicly Available Information of Certification Body • Website Certification Body Certification Processes Scheme Details Granting Maintaining Applications Registered Extending Certifications Granted Renewing • Scheme Information on Reducing Suspended or Withdrawn Suspending Withdrawing Certification Validity of a given Certification Geographical Area of Operations
Seeking information from a CB post approval – SIGNIFICANT Changes • Legal , Commercial, Ownership or Organisational Status Documentation • The Organisation , Top Management and key Personnel Human Resources • Main Policies Clauses • Resource and Premises Infrastructure • Scope of Approval Content Specifications • Other such matters Miscellaneous
Suspension / Withdrawal of Provisional Approval Non Compliance w.r.t scheme’s requirements Suspension of NABCB accreditation for ISO 17021
Fee Structure ( under revision process) • Rs. 10,000/- Application Fee • Rs. 20,000/- per Man-day Man-day Charges • On actuals Travel / Stay Expenses • To be duly Communicated at QCI’s Changes on Fee discretion with due notice to CB
Ongoing Schemes in PAD Division IndGHP & RMCPCS IndGAP IndHACCP BSCS TCHP VCSMPP STAR 17
Thank You C S Sharma Deputy Director Project Analysis & Documentation Division (PADD) Quality Council of India p: +91 11 23379321 / 9621 a: Indian Council for Child Welfare, 2nd Floor, New Delhi - 2, India w: www.qcin.org m: csharma@qcin.org
Approach to Indian Certification of Medical Devices (ICMED) Certification -- Certification Process -- Webinar on 21 May 2020 Mrutunjay Jena QUALI LITY Y Director, NABCB/QCI COUNCIL OF IN INDIA
Agenda Contents…. Type of ICMED Certification Certification Criteria − Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device Registration Process − Application − Information for Applicants − Information to CB before office assessment Audit Process − Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate Maintaining Certification − Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure 20 − ICMED Symbol
Type of Certification Schemes ICMED 9000 which is based on ISO 9001:2015 + Additional requirements (29) ICMED 13485 which is based on ISO 13485:2016 + (MDR 2017 + Additional Requirements)=270 ICMED 13485 Plus Which is ICMED 13485 + Product specifications (As per ISO/IEC/BIS/NHSRC etc) Scheme Applicability: For Manufacturers of MDs
MD Manufacturers Category of Medical Devices % of Minimum Local Content Medical Disposables and Consumables 50% Medical Electronics, Hospital Equipment, Surgical 25% Instruments Implants 40% Diagnostic Reagents / IVD 25% As defined in Guidelines by DOP on Make in India PPO:2017, subject to revision 22
ICMED Scheme ICMED 9000 ICMED 13485 − ISO 9001:2015 − ISO 13485:2016 − Labelling requirement list – − MDR 2017 ICMED − Installation, Maintenance, − Essential requirements for safety Repair, Service and Rework of Medical Device procedure − ICMED − Labelling requirement list – 9000_Issue2_19012019.pdf ICMED − QCI AIMED ICMED 13485 R3 − Labelling requirements – MDR 11 03 2019.pdf − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device 23
Agenda Contents…. Type of ICMED Certification Certification Criteria − Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device Registration Process − Application − Information for Applicants − Information to CB before office assessment Audit Process − Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate Maintaining Certification − Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure 24 − ICMED Symbol
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