Medical Device Product Innovation

Transcription

1 Medical Device Product Innovation Madoka Murakami PMDA, Japan AMDC Industry Training, 3-5 Oct 2017, Surabaya

2 Agenda Introduction of PMDA Medical Device TPLC and Quality Management Typical Nonconformities for QMS

3 - Regulatory Authorities in Japan - MHLW Ministry of Health, Labor and Welfare Final authorization for administrative decisions (approval, safety measures, etc.) Publishing notifications/guidelines Advisory committee Etc. PMDA Pharmaceuticals and Medical Devices Agency Scientific Review GCP, QMS/GMP Inspection AER collection/analysis Consultations for manufactures etc. 3

4 Where PMDA locates

5 Role of PMDA Drug and Medical Device Reviews Post-marketing Safety Relief Services for Adverse Health Effects Scientific reviews of pharmaceuticals and medical devices Consultation (Planning of clinical trials, etc.) GCP, GLP, QMS/GMP inspections and conformity audit on dossiers Collection of safety information (database) Analysis and dissemination of information Services for consumers about safe use Relief system for drug adverse effects and infections by biologics Providing healthcare allowance to the patients - SMON, HIV Special measures for the patients infected by Hepatitis C through specified preparations

6 Number of Executives and Regular Employees Total (including executives) Review Dpt Safety Dpt Relief Dpt

7 Quantitative Increase and Background of Medical Device Reviewers

8 Medical Devices Regulation EU Japan US Brazil Canada Singapore Notified body certification (requirements depend on device classification) Class III, IV: Minister s approval Class II: Notified body certification Class I: Selfdeclaration Pre-market review Class III: PMA Approval Class II: 510(k) clearance, Class I: exemption Class III, IV: Registro to ANVISA Class I, II: Cadastro to ANVISA Class II, III, IV: License from Health Canada Class I: exemption Class B, C, D: Registration to HAS Some of Class A: exemption Governmental approval/license Notified body review/certification Self declaration/exemption

9 Overview of Medical Device Regulation Classification (based on GHTF classification rule) Class I Class II Class III Class IV Extremely low risk Low risk Medium risk High risk Example X-Ray film MRI Dialyzer, Artificial bone Pacemaker, Artificial heart valve Category General MDs Controlled MDs Specially controlled MDs Review regulation (including QMS) Self-declaration Third party certification Minister s approval (PMDA s review) Post-market safety vigilance/surveillance PMDA and MHLW Re-examination for Brand New MDs, Re-evaluation, AE reporting, Researches, etc.

10 History of medical device regulations in Japan recent big amendments (1/2) Medical Device has been regulated in Japan since 1960, and there have been 2 big amendments for the regulations recently; 1. Amendment in Introduction of Marketing Authorization Holder system 2 Introduction of Registered Certification Body system 3 Introduction of medical device classification based on the GHTF classification rule 4 Introduction of STED and Essential Principles 5 Introduction of GCP as a ministerial ordinance 6 Introduction of QMS, instead of GMP 10

11 History of medical device regulations in Japan recent big amendments (2/2) 2. Amendment in Amendment of Registered Certification Body system, including expansion of scope 2 Improvement of regulations on manufacturer 3 Improvement of QMS inspection 4 Application of medical device regulations on SaMD (Software as a Medical Device) 5 Establishment of a new category, Regenerative Medicine Product 11

12 Performance goals for total standard product review time Performance goal: total review time (80th percentile, unit: month) Brand-new MD Standard items Total time (Agency : Applicant) 12 (7 : 5) Priority items Total time (Agency : Applicant) 9 (5 : 4) Improved MD w/ clinical data Total time (Agency : Applicant) 9 (5 : 4) w/o clinical data Total time (Agency : Applicant) 7 (4 : 3) Generic MD NDA Total time (Agency : Applicant) 5 (2 : 3) PCA Total time (Agency : Applicant) 4 (2 : 2) 12

13 Breakdown Number of approvals of Medical Devices FY2012 FY2013 FY2014 FY2015 FY2016 Medical devices (total) ,347 1, Priority review items (included in total) Band-new MDs Others (e.g. Improved MDs w/wo clinical data, Me-too MDs) 1,489 1,253 1, Number of certifications by registered certification bodies Certification (including partial change certification) 2,350 2,417 2,276 1,452 1,079 13

14 Acceptance of Foreign Clinical Data MHLW/PMDA have accepted foreign clinical data for years if it is good enough to evaluate a device s clinical safety and efficacy on Japanese population under Japanese medical practice/environment. Number of devices approved after review with clinical trial data Foreign clinical data only FY2012 FY2013 FY2014 FY2015 FY Both foreign and Japanese clinical data Japanese Clinical data only (Source: PMDA Annual Report FY2016) 14

15 PMDA s Consultation Number of consultations FY2010 FY2011 FY2012 FY2013 FY2014 FY2015 FY *Source: PMDA annual report FY

16 Global Activities of PMDA Summit APEC LSIF RHSC Abbreviation Summit ICH IMDRF PIC/S HBD APEC LSIF RHSC OECD MAD PDG IGDRP ICH OECD IMDRF PDG PIC/S IDGRP HBD Official Name International Summit of Heads of Medicines Regulatory Agencies International Conference on Harmonization International Medical Device Regulators Forum Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Harmonization By Doing APEC Life Science Innovation Forum Regulatory Harmonization Steering Committee OECD Mutual Acceptance of Data Pharmacopoeial Discussion Group International Generic Drug Regulators Pilot and more 16

17 Agenda Introduction of PMDA Medical Device TPLC and Quality Management Typical Nonconformities for QMS

18 Medical Device Quality Safety Patient Effective ness

19 Quality can realize intended safety and effectiveness Without quality, safety and effectiveness cannot be reliable Safety Effectiveness Quality

20 GHTF(Global Harmonization Task Force) Regulatory Model GHTF/AHWG-GRM/N1R13:2003 The GHTF has created over time guidance documents that together are providing an overall view of a internationally harmonized medical device regulatory model. The GHTF Steering Committee considered it would be very useful to have in one document an overall view on all developed GHFT guidances that, together, would provide a concise harmonized medical device regulatory model. It is hoped that promotion and adoption of GHTF guidance will lead to international convergence of regulatory requirements and practices for medical devices. 20

21 Medical Device Life-cycle Destruction, Disposal, Manufacture, use of parts CONCEPT END OF PRODUCT LIFE Design inputs leading to new concept or newer version PRODUCT REALISATION Feedback into new design or manufacturing corrections or improvements based on market experience PRODUCT USE PLACING ON THE MARKET GHTF/AHWG-GRM/N1R13:

22 Existing technologies Innovative Technologies Technologies beyond Standards CT or New test method Standards MD1 MD2 MD3 22

23 Purpose Classification Existing medical device/therapy Difference Applicable standards Appropriate in-house testing Clinical trials

24 GHTF/AHWG-GRM/N1R13:

25 IMDRF/SaMD WG/N23 FINAL: 2015

26 Pre market Post market R&D Design Applic ation Documentation Risk Base Classification Validation Verification EP STED ISO QMS ISO Risk Management 26

27 Agenda Introduction of PMDA Medical Device TPLC and Quality Management Typical Nonconformities for QMS

28 Overview of Nonconformities in Japan Design Ctrl/ Pchg. Ctrl. [ パーセン [ パーセンテーテージ ] ジ ] MAH [ パーセンテージ ] Mfg. [ パーセンテージ ] CAPA [ パーセンテージ ] Mgmt. Ctrl [ パーセンテージ ] Doc.Ctrl [ パーセンテージ ] Customer [ パーセンテージ ] Product Doc. [ パーセンテー Nov ~ ジ ]

29 ISO13485, 6.2 Case Management Control - Training The necessary competence for personnel performing work affecting product quality is not determined. Point to care Determine the necessary competence for the personnel performing work affecting product quality Target level Actual level Competence Skill and Knowledge Training and Evaluation Internal auditor, Complaint handling people Risk management etc. 53

30 ISO13485, Management Control - Mgmt. Review Cases The output from the management review is not observed. The quality objectives is required to be reviewed by management review per their site procedure. However the result of the review is not observed. Point to care Record the outputs of the management review. Management review Output Input 54

31 ISO13485, Cases Management Control Internal audit Some departments included in their QMS scope are not covered for their internal audit and does not comply with the additional requirements of Japanese QMS ordinance Points to care Conduct the internal audit to every departments included in the scope based on QMS ordinance. Internal Audit -Applicable law -QMS scope : Applicable depts. within Organization. 55

32 ISO13485, 7.1 Design Control/Risk management Cases The requirements for risk management throughout product realization is not determined. Manufacturer do not review and evaluate the results of risk management activities conducted by overseas registered manufacturing site. The review of risk assessment is not conducted. The trigger of reviewing of the risk management is not identified. The attached documents created(and/or revised) based on risk management file is not observed. Points to care Establish the documented requirements for risk management. Documented requirements for Risk management 60

33 ISO13485, Production and process control Cases Not incorporate the validated process parameters into practice appropriately. (Process parameters : ex. machine adjustment, sterilizing condition, environmental control in manufacturing area or in storages.) Change some parameters without any validation nor checking the validation report. Point to care Release the validation process after validated the process per the procedure.

34 ISO13485, Production and process control Case The user training is required after the product is approved. However, the procedure for the user training is not documented. Point to care Establish the procedure for the user training. Application dossier QMS Need training prior to use this medical device Documented Procedure for User Training 64

35 ISO13485, 7.4.1, Purchasing control Cases The supplier providing service activities such as calibration service was not controlled. The site evaluates the supplier by using the supplier selection form. However, the criteria for the supplier selection is not determined. Manufacturer purchases the product from overseas registered manufacturing site. However, the purchasing information is not identified. Point to care Determine the requirements for purchasing control and document the procedure. SOP Supplier control -Scope -Criteria -Evaluation -Monitoring Scope Purchasing information 65

36 ISO13485, CAPA (Corrective Action; Preventive Action) Cases The review of the effectiveness of the corrective action was not taken. The nonconformity of QMS process was not covered by CAPA process. The results of corrective action for external audit was not controlled appropriately. The customer complaint related to the overseas registered manufacturing site is informed to the overseas registered manufacturing site in place. And not followed by CAPA action as conclusion. However the record of the reason is not recorded. Point to care Review the procedure or quality agreement between local distributor and overseas registered manufacturing site. 66

37 Collaboration Among Stakeholders Collaboration among Industry, Government and Academia Industry Academia People Regulatory Authorities

38 Thank you!!