Guidance Library
Key regulatory guidance documents across all jurisdictions
66 documents
GN-13: Risk Classification of General Medical Devices
16 classification rules for determining device risk class (A/B/C/D) under the ASEAN harmonized framework.
GN-14: Risk Classification of IVD Devices
Classification rules specific to in vitro diagnostic medical devices under ASEAN IVDD.
GN-12-1: Grouping of Medical Devices (General Criteria)
Criteria for grouping device variants into a single product registration.
GN-15: Product Registration (General Medical Devices)
CSDT submission requirements for Class B/C/D product registration. R13 (Mar 2026) with AI/ML SaMD guidance.
GN-36: Medical Device UDI System
Unique Device Identification implementation requirements for the Singapore market.
GN-34: Guidance for IVD Analysers
Registration requirements specific to IVD analyser instruments and their software.
GN-17: ASEAN CSDT Submission for General Medical Devices
Step-by-step guidance on preparing the ASEAN Common Submission Dossier Template for GMD.
GN-18: ASEAN CSDT Submission for IVD Medical Devices
CSDT dossier preparation guidance tailored to IVD-specific documentation requirements.
GN-16: Essential Principles for Safety and Performance
14 general Essential Principles implementing IMDRF safety and performance requirements.
GN-20: Clinical Evaluation
Clinical evaluation, clinical investigations, equivalence claims, and PMCF requirements.
GN-11: Declaration of Conformity
Requirements for the manufacturer's Declaration of Conformity referencing Essential Principles.
GN-23: Labelling for Medical Devices
Device labelling and Instructions for Use requirements aligned with ISO 15223-1.
GN-21: Change Notification for Registered Medical Devices
Requirements for notifying HSA of changes to registered devices (PN vs CA decision tree).
GL-04: Regulatory Guidelines for Software Medical Devices
Lifecycle approach to SaMD regulation — definition, classification, IEC 62304, cybersecurity, AI/ML.
GL-07: Risk Classification of SaMD and Qualification of CDSS
IMDRF SaMD risk categorisation matrix and CDSS regulatory boundary criteria.
GN-37: Change Management Program for SaMD (incl. ML-enabled)
CMP framework and predetermined change control plans for AI/ML-based SaMD.
GN-02: Licensing of Manufacturers, Importers, and Wholesalers
Dealer's Licence requirements for the medical device supply chain in Singapore.
GN-22: Guidance for Dealers on Class A Medical Devices
Requirements for dealers supplying Class A devices — licence and listing obligations.
GN-33: Application of Singapore Standard GDPMDS
Good Distribution Practice for Medical Devices — storage, transport, traceability.
GN-35: Special Access Routes
Access to unregistered medical devices for specific patient or institutional needs.
510(k) Program
Premarket notification pathway for devices substantially equivalent to a legally marketed predicate.
De Novo Classification Process
Pathway for novel low-to-moderate risk devices with no predicate device.
Clinical Evidence for Devices
FDA guidance on clinical study design, endpoints, and evidence expectations.
Software as a Medical Device (SaMD)
Framework for regulation of software functions that meet the definition of a device.
Cybersecurity in Medical Devices
Premarket and postmarket cybersecurity expectations for connected devices.
Human Factors and Usability Engineering
Applying human factors processes to medical device design and validation.
Biocompatibility (Use of ISO 10993)
Recommendations for evaluating biocompatibility of medical devices in contact with the body.
Design Controls (21 CFR 820.30)
Quality system requirements for device design and development processes.
Essential Principles of Safety & Performance
Fundamental requirements that all medical devices must satisfy for the Australian market.
Conformity Assessment Procedures
Assessment procedures required for ARTG inclusion based on device classification.
ARTG Registration Guidance
Step-by-step guide to registering medical devices on the Australian Register of Therapeutic Goods.
Clinical Evidence for Medical Devices
TGA expectations for clinical data supporting device safety and performance claims.
General Safety & Performance Requirements (GSPR)
Annex I requirements that all devices must fulfil under Regulation (EU) 2017/745.
Clinical Evaluation (Annex XIV)
Requirements for systematic clinical evaluation and post-market clinical follow-up.
CE Marking Process
Steps to achieve CE marking including conformity assessment and Notified Body involvement.
Post-Market Surveillance (PMS)
Ongoing obligations for vigilance, trend reporting, and periodic safety update reports.
EUDAMED Database
European database for medical devices — registration, UDI, and market surveillance data.
Medical Devices Regulations SOR/98-282
Principal regulations governing classification, licensing, and post-market requirements for medical devices in Canada.
MDSAP Audit Requirements
Medical Device Single Audit Program — mandatory QMS audit pathway for Canadian market access.
Medical Device Licence Application Guide
Step-by-step guidance for preparing and submitting a Medical Device Licence application.
PMD Act — Device Classification Rules
Japanese classification system for medical devices: Todokede (notification), Ninsho (certification), Shonin (approval).
PMDA Pre-submission Consultation Guide
Guidance on PMDA's pre-submission consultation process for medical device approval applications.
MAH/DMAH Requirements for Foreign Manufacturers
Requirements for Marketing Authorization Holders and Designated MAH for devices manufactured outside Japan.
Medical Devices Act — Classification Rules
Korean 4-class risk classification system (I-IV) with KGMP requirements for each class.
KGMP (Korean Good Manufacturing Practice)
Korean GMP requirements for medical device manufacturing, aligned with ISO 13485.
Substantial Equivalence Review Pathway
Expedited review pathway for devices substantially equivalent to already-approved Korean products.
Medical Device Classification Catalogue 2018
NMPA's comprehensive classification catalogue for medical devices — Classes I, II, III with product codes.
In-Country Testing Requirements
Requirements for mandatory testing at NMPA-designated Chinese laboratories for imported medical devices.
Registration Application Guide for Imported Devices
Step-by-step guide for foreign manufacturers seeking NMPA registration for the Chinese market.
Medical Device Rules 2017 (MDR 2017)
Principal regulations governing import, manufacture, sale, and distribution of medical devices in India.
SUGAM Online Portal Guide
Guide to using the CDSCO SUGAM portal for medical device import licence and registration applications.
Import Licence Requirements
Requirements for obtaining an import licence for foreign medical devices, including Authorized Agent obligations.
Medical Device Act B.E. 2551 (2008)
Principal legislation governing medical devices in Thailand — 3-class system with ASEAN CSDT submissions.
HSA Regulatory Reliance Programme
Details on the HSA–Thai FDA reliance route: 60 working days, specialist review exemption, dossier sharing.
ASEAN CSDT Preparation Guide (Thailand)
Guidance on preparing the ASEAN Common Submission Dossier Template for Thai FDA submissions.
Medical Device Act 2012 (Act 737)
Principal legislation establishing MDA's authority over medical device registration and conformity assessment in Malaysia.
CAB Conformity Assessment Guide
Requirements for Conformity Assessment Body review for Class B, C, and D devices in Malaysia.
HSA Mutual Reliance Pilot Guidelines
Guidelines for the HSA–MDA mutual reliance pilot: 30-day CAB review + 30-day registration for HSA-approved devices.
Decree 98/2021/ND-CP — Medical Devices
Principal decree governing medical device management in Vietnam — classification, registration, and post-market surveillance.
Fast-Track Registration Guidelines
MOH guidance on expedited registration for Class C/D devices with reference country approval (USA, Canada, EU, Japan, Australia).
Administrative Order 2021-0004
Updated guidelines for registration and licensing of medical devices in the Philippines under RA 9711.
HSA Reliance Route Guidelines (Philippines)
PFDA guidance on HSA reliance pathway — 30 working days for HSA-approved devices, up to 83% faster.
ISO 13485:2016 — Quality Management Systems
Requirements for a comprehensive QMS for the design and manufacture of medical devices.
ISO 14971:2019 — Risk Management
Application of risk management to medical devices throughout the product lifecycle.
ISO 10993 — Biocompatibility
Series of standards for evaluating the biological safety of medical device materials.
IEC 62304 — Software Lifecycle
Software lifecycle processes for medical device software and SaMD development.