Regulatory Updates Health Sciences Authority Singapore Wong Woei Jiuang Director, Medical Devices Branch, Health Sciences Authority, Singapore
Scope Background Pre-market Consultation (PMC) Scheme • Medical Device Development Consultation • Medical Device Pre-submission Consultation Priority Review Scheme • Qualification Criteria • Priority Review Scheme Routes
Background Support Innovation and Device Development Locally Committee on the Future Economy (CFE) Recommendations ● Engage researchers and developers ● Enable better understanding of regulatory requirements at early stage of device development Facilitate timely access for Medical Devices that demonstrate the potential to address unmet clinical needs To differentiate HSA as a trusted regulatory leader to help local enterprises expand overseas
HSA’s Initiatives 1. Pre-Market Consultation 2. Priority Review Scheme Scheme Support innovation and device Facilitate timely access for devices development by ensuring devices that address unmet clinical needs are in line with regulatory requirements To provide support through the device development lifecycle DEVELOP + POST – DISCOVERY + REGULATORY PRODUCT PRE- CLINICAL MARKET IDEATION SUBMISSION LAUNCH CLINICAL MONITORING
Support innovation and device development MEDICAL DEVICE PRE-MARKET CONSULTATION (PMC) SCHEME
2 Pre-Market Consultation (PMC) Scheme Medical Device Pre-submission Consultation Channel for stakeholders seek regulatory to Channel for stakeholders to advice during medical seek feedback on their device device development dossier, prior to pre-market phase to align with submission in terms of 1 regulatory requirements. completeness and appropriateness of supporting Medical Device documents. Development Consultation PRODUC DEVELOP + POST – DISCOVERY + REGULATORY PRE- CLINICAL MARKET T IDEATION SUBMISSION CLINICAL MONITORING LAUNCH
SCOPE: Clarification on regulatory requirements applicable to the device in development, which may include Channel for stakeholders • Regulatory requirements seek regulatory to – Device claims advice during medical – Safety / Performance studies device development – Sterility phase to align with – Biocompatibility 1 regulatory requirements. – Risk management – Clinical trials Medical Device • Regulatory strategy Development Consultation PRODUC DEVELOP + POST – DISCOVERY + REGULATORY PRE- CLINICAL MARKET T IDEATION SUBMISSION CLINICAL MONITORING LAUNCH
1. Medical Device Development Consultation For 1 specific Who When What device or a Medical device Any time group of during device developers, devices development researchers intended to be used together What it is not Endorsement of any validation plans, test protocols and/or results that were discussed in the consultation Does not guarantee approval or marketing clearance Not meant to be an iterative process
2 Medical Device SCOPE: Seek feedback on the Pre-submission device dossier, in accordance to prescribed Common Submission Consultation Dossier Template (CSDT) guidance template, which may include Channel for stakeholders to seek feedback on their device • Risk Classification dossier, prior to pre-market • Registration Route submission in terms of • Grouping completeness and • Technical & administrative appropriateness of supporting documents documents. PRODUC DEVELOP + POST – DISCOVERY + REGULATORY PRE- CLINICAL MARKET T IDEATION SUBMISSION CLINICAL MONITORING LAUNCH
2. Medical Device Pre-Submission Consultation Who When What Stakeholders Before Devices to submitting submission be registered medical of pre-market in 1 single devices for application to pre-market registration HSA application locally What it is not Not a scientific evaluation of the device Does not guarantee regulatory approval or marketing clearance
Step 2: Document Submission
Pre-Market Consultation (PMC) Scheme Following are examples of queries which do not require PMC : • General questions regarding registration procedures or documentary requirements for product registration. • Clarification on the guidance documents on the website. • To seek advice on the risk classification or grouping. • During the review process of a product registration. • To appeal a decision made during pre-market submission. These enquiries can be sent as general enquiries / using dedicated enquiry form(s) to HSA_MD_Info@hsa.gov.sg, or to contact officer in charge for clarification related to specific application.
Facilitate timely access for Medical Devices that demonstrate the potential to address unmet clinical needs MEDICAL DEVICE PRIORITY REVIEW SCHEME
Route 2 Medical devices* to be registered via FULL Evaluation Route Qualification Criteria Designed & validated to 1 2 Falls under 1 of the meet unmet clinical needs 5 healthcare focus area Intended for a medical purpose with • Cancer no existing alternative treatment or • Diabetes means of diagnosis • Ophthalmologic diseases OR • Cardiovascular diseases breakthrough Represents a technology that provides a clinically • Infectious diseases meaningful advantage over existing legally marketed technology Route 1 * Class A and devices incorporating registrable medicinal/ therapeutic products are not eligible for the Priority Review Scheme.
Turn-Around-Time (TAT) & Fees TAT (in working days) Evaluation Fee ($) Route 1 & 2 Route 1 Route 2 Risk Class 25% reduction 35% reduction 15% increase 50% increase by mid 2018 by end 2019 over current fee over current fee Class B 120 105 4,100 5,300 (FULL) Class C 165 145 6,600 8,600 (FULL) Class D 235 205 13,200 17,100 (FULL)
Upcoming Documents • Update to the Guidance on Preparation of the ASEAN CSDT* for Medical Devices and In Vitro Diagnostics (IVDs) • Registration and listing of IVD analysers and instruments 16 * Common Submission Dossier Template
Thank you!
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