Global Harmonization Task Force
This article was originally published in RAJ Devices
Executive Summary
Update on study groups
Update on study groups
Following a series of meetings in the first half of 2004, study groups of the Global Harmonization Task Force (GHTF) have issued a number of guidance documents relating to basic regulatory practice in the medical device sector. These documents appear below, together with their reference numbers. The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry.
Study group 1
Study group1 (SG1) of the GHTF is responsible for comparing operational medical device regulatory systems around the world and identifying principles that may be suitable for harmonisation1. In addition, the group is responsible for developing a standardised format for premarket submissions and harmonised product labelling requirements. The next meeting of SG1 will be held in Portugal on 4-7 October 2004.
Item | Reference | Status | Target for completion |
Principles of Medical Devices Classification | SG1/N015 | Proposed document comments awaited. | 2004 / Q4 |
Principles of Conformity Assessment for Medical Devices | SG1/N040 | Revised working draft to incorporate comments from SG1 membership. | 2005 / Q1 |
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles for Safety and Performance (STED) | SG1/N011 | Proposed document comments awaited. | 2004 / Q4 |
Information Document Concerning the Definition of the Term ‘Medical Device’ | SG1/N029 | Proposed document - comments awaited. | 2004 / Q3 |
Labelling for Medical Devices - Revision of SG1/N009 | SG1/N043 | Latest draft being submitted to the steering committee as a proposed document. | 2005 / Q1 |
Essential Principles for Safety and Performance of Medical Devices - Revision of SG1/N020 | SG1/N041 | Proposed document - comments awaited. | 2004 / Q3 |
Role of Standards in the Assessment of Medical Devices - Revision of SG1/N012 | SG1/N044 | Proposed document - comments awaited. | 2004 / Q4 |
Classification of In Vitro Diagnostic Devices | SG1/N045 | Working draft to be circulated to SG1 shortly | 2005 / Q1 |
Premarket Conformity Assessment for In Vitro Diagnostic Devices | SG1/N046 | Subgroup preparing first draft | 2004 / Q3 |
Study group 2
Study group 2 (SG2) reviews current adverse event reporting, postmarket surveillance and other forms of vigilance for medical devices to try and harmonise data collection and reporting systems. The next meeting of SG2 will be held in Vancouver on 27-29 September 2004.
Item | Reference | Status | Target for completion |
Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan | SG2/ N6R3 | NA | NA |
Minimum Data Set for Manufacturer Reports to Competent Authority | SG2/ N7R1 | NA | NA |
Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices | SG2/ N8R4 | NA | NA |
Global Medical Device Competent Authority Report | SG2/ N9R11 | NA | NA |
Precis - GHTF Study Group 2: Vigilance and Postmarket Surveillance | SG2/ N12R9 | NA | NA |
Charge & Mission Statement | SG2/ N16R5 | NA | NA |
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria | SG2/ N20R10 | NA | NA |
Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative | SG2/ N21R8 | NA | NA |
Medical Device Postmarket Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative | SG2/ N31R8 | NA | NA |
Medical Device Postmarket Vigilance and Surveillance: Universal Data Set for Manufacturer Adverse Event Reports | SG2/ N32R5 | NA | NA |
Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse Event Reports | SG2/ N33R11 | NA | NA |
Manufacturer's Trend Reporting of Adverse Events | SG2/ N36R7 | NA | NA |
Review of Current Requirements on Postmarket Surveillance | SG2/N47R2.1 | NA | NA |
Medical Device Postmarket Vigilance and Surveillance: Application Requirements for Participation in the GHTF National Competent Authorities Report (NCARs) Exchange Programme | SG2/N38R11.2 | NA | NA |
Global Guidance for Adverse Event Reporting for Medical Devices | SG2/N54R2 | NA | NA |
Harmonisation of the Content of Advisory Notices and Recalls | SG2/N57R1 | NA | NA |
Study group 3
Study group 3 examines existing quality system requirements in countries with developed device regulatory systems and identifies areas suitable for harmonisation.
Item | Reference | Status | Target for completion |
Guidance on Quality Systems for the Design & Manufacturing of Medical Devices | SG3/ N99-8 | NA | NA |
Design Control Guidance for Medical Device Manufacturers | SG3/ N99-9 | NA | NA |
Quality Management Systems - Process Validation Guidance | SG3/ N99-10 (Edition 2) | NA | NA |
SG3 Comments on ISO/DIS 13485 submitted to ISO TC 210 Working Group 1 | SG3 | NA | NA |
Risk Management as an Integral Part of the Quality Management System | SG3/ N15R6 | NA | NA |
Study group 4
Study group 4 (SG4) examines quality system auditing practices (initially among the founding members of the GHTF) and develops guidance documents to harmonise the medical device auditing process. The next meeting of SG4 will be held in Canberra on 27-29 September 2004.
Item | Reference | Status | Target for completion |
Training Requirements for Auditors (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 2) | SG4/(00)3 | NA | NA |
Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1) | SG4/(99)14 | NA | NA |
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements | SG4/(99)28 | NA | NA |
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7) | SG4/N24R3 | NA | NA |
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies | SG4/N26R1 | NA | NA |
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy | SG4/N30R6 | NA | NA |
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports | SG4/N33R4 | NA | NA |
References
1. GHTF website, www.ghtf.org
2. SG2 Phoenix meeting summary, www.ghtf.org
3. SG4 Tokyo meeting summary, www.ghtf.org
4. SG1 Canberra meeting summary, www.ghtf.org