Regulatory requirements for SaMD across jurisdictions. Where to start?
SaMD regulatory requirements are fast evolving and although there are initiatives for harmonisation through the Medical Device Coordination Group Working Groups and the International Medical Device Regulators Forum, as well as the position of the United States’ Quality System Regulation (QSR) to incorporate and align more closely with the ISO 13485:2016 to become effective in February 2026 manufacturers still have to account for the requirements of different jurisdictions. So where to start?
As a manufacturer navigating the complex world of regulations and when planning your Regulatory Strategy, see our earlier blogs on what you need to embark on your regulatory submissions, as well as your market strategy for the key considerations on your risk classification and which markets to target, including which market would you like to target first will determine your medical device regulatory pathway:
With new emerging markets and niche technologies, particularly with AI, manufacturers are gradually expanding their horizons beyond the EU and US markets.
To help you navigate the regulatory requirements across your potential markets we have summarised below key considerations across ten jurisdictions in the sections below.
Watch this space for another handful of jurisdictions to be shared soon and do get in touch if you need help with mapping your SaMD to any jurisdiction.
Great Britain
Regulation
[UK MDR 2002]
SI 2002 no. 618 (United Kingdom)
The Medical Devices Regulations 2002
as amended by SI 2020 no. 1478
UK Postmarket Reg Regulations 2024
SI 2024 No. 1368 made 2024-01-16 and in force from 2025-06-16
Regulatory authority
MHRA - the UK’s National Competent Authority (NCA)
UK Approved Bodies (UKABs) designated by the MHRA
Classification
Class I
Class IIa
Class IIb
Class III
Per [EU IVDD]:
General IVDs
Self-testing
IVDs in List A
IVDs in List B
Overseas approvals
[EU MDR]
[EU IVDR] to be used as conformity evidence
Representative
UK Responsible Person - UKRP
Acts on behalf of the non-UK manufacturer to ensure compliance and liaise with the MHRA
Application (in-country manufacturer)
UKCA mark - via a UK Approved Body (Approved Bodies are listed on the UK Market Conformity Assessment Bodies database, UK MCAB)
CE mark - via a EU Notified Body (until at least 30th June 2030) - Regulating medical devices in the UK - GOV.UK
Application (overseas manufacturer)
UKRP to register the UKCA or CE marked device with MHRA
EU + Northern Ireland
Regulation
[EU MDR]
EU 2017/745 Medical Device Regulation
[EU IVDR]
EU 2017/746 In-vitro Diagnostic Medical Device Regulation
Regulatory authority
The European Commission
The National Competent Authority (NCA) or each EU member state
EU Notified Bodies (NBs) designated by the NCA of their country of residence
Classification
Class I
Class IIa
Class IIb
Class III
Class A IVD
Class B IVD
Class C IVD
Class D IVD
Representative
European Authorised Representative - EAR
Represents the non-EU manufacturer to ensure compliance and liaise with authorities
Application (in-country manufacturer)
Reviewed and approved by Notified Bodies (NB are supervised by Competent Authorities within EU member states) - Notified Bodies are listed on the database NANDO
Application (overseas manufacturer)
Approved by a Notified Body
USA
Regulation
[21CFR]
Title 21 of the Code of Federal Regulations
(specific regulation depends on intended classification)
Regulatory authority
FDA
Classification
Class I
Class II
Class III
Representative
U.S. Agent
Represents the non-U.S. manufacturers
Acts as a point of contact with the FDA, however does not take legal responsibility for the device
Application (in-country manufacturer)
510(k) submission - substantial equivalence, usually for medium risk devices (Class II);
Premarket Approval - PMA; usually for high risk devices (Class III);
De Novo - novel devices, low to moderate risk without a predicate device;
Breakthrough Device designation - for effective diagnosis of life-threatening or irreversibly debilitating conditions, for which no approved or cleared alternatives exist
Application (overseas manufacturer)
Reviewed by FDA
Australia
Regulation
[TGA MDR]
Therapeutic Goods (Medical Devices) Regulations 2002
Regulatory authority
Therapeutic Goods Administration - TGA
Classification
Class I
Class IIa
Class IIb
Class III
Class 1 IVD
Class 2 IVD
Class 3 IVD
Class 4 IVD
Overseas approvals
[EU MDD/MDR]
[EU IVDD/IVDR]
[21CFR]
[HC MDR]
[PMDA] Japan
[HPA] Singapore
QMS:
MDSAP
BS EN ISO 13485:2016+A11:2021 certificates
Representative
Australian Sponsor is responsible for regulatory submissions to the TGA and registration with ARTG
Australian manufacturers are typically Sponsors
Non-AUS manufacturers must appoint an Australian Sponsor.
Application (in-country manufacturer)
Conformity Assessment from TGA (except for Class I)
Sponsor submit evidence of manufacturer's compliance
Sponsor submits application for ARTG entry
Application (overseas manufacturer)
Process divided: Part A - Abridgment of TGA conformity & Part B - ARTG inclusion
Self-certified devices:
-Part A: DoC + Essential principles
-Part B: self- declaration process
All other devices:
-Part A: Manufacturer Evidence + DoC
-Part B: Evidence of product assessment (documentation from overseas regulators)
Hong Kong
Regulation
[HK MDD]
Regulatory authority
Medical Device Division- MDD - responsible for approving medical devices.
Classification
Class I
Class II
Class III
Class IV
Class A IVD
Class B IVD
Class C IVD
Class D IVD
Overseas approvals
[EU MDD/MDR]
[EU IVDD/IVDR]
[21CFR]
[HC MDR]
[PMDA] Japan
[HPA] Singapore
[NMPA] China
[MFDS] South Korea
QMS:
BS EN ISO 13485:2016+A11:2021 certificates or equivalent
Representative
Local Responsible Person is responsible for regulatory compliance, PMS and communication with [HK MDD] for
overseas manufacturers
Application (in-country manufacturer)
Conformity Assessment - Except Class I and A - by a Conformity Assessment Body (CAB)
Declaration of Conformity by the manufacturer
Application (overseas manufacturer)
Medical Device Administrative Control System - MDACS (registration is voluntary, however, recommended)
Approved medical devices: overseas assessments and approvals can be used to apply to MDACS
Non-approved medical devices: may apply via conformity assessment route to MDACS
Canada
Regulation
[HC MDR]
Canada Medical Devices Regulations - Regulation - under the Food and Drugs Act
Regulatory authority
Health Canada
Classification
Class I
Class II
Class III
Class IV
Class I IVD
Class II IVD
Class III IVD
Class IV IVD
Overseas approvals
Health Canada does not recognise approvals from other jurisdictions.
QMS: MDSAP is mandatory for all classes except Class I
Representative
No in country representation is needed
As a foreign manufacturer an importer is needed to import and distribute the device.
Application (in-country manufacturer)
Class I: need MDEL; no MDL or MDSAP
Class II-IV: need MDL and MDSAP
Application (overseas manufacturer)
ALL manufacturers are subject to the same regulatory pathway:
Medical Device Establishment Licences - MDEL - import (Class I-IV), distribute (Class I-IV) or manufacture (Class I) medical devices.
Medical Device Licenses - MDL - Class II-IV cannot be sold or imported in Canada without a valid MDL;
Singapore
Regulation
[HPA]
Health Products Act
Health Products (Medical Devices) Regulations 2010
Regulatory authority
Health Sciences Authority - HSA
Classification
Class A
Class B
Class C
Class D
Class A IVD
Class B IVD
Class C IVD
Class D IVD
Overseas approvals
[EU MDD/MDR]
[EU IVDD/IVDR]
[TGA MDR]
[21CFR]
[HC MDR]
[PMDA] Japan
QMS:
MDSAP
BS EN ISO 13485:2016+A11:2021 certificates
Representative
Registrant - responsible for applying and holding the registration with HSA. Registrations can only be transferred to another Registrant if the current Registrant agrees to relinquish it.
Application (in-country manufacturer)
Full Evaluation Route (also applicable for overseas manufacturers with no prior approval)
Application (overseas manufacturer)
Class A (Exempt devices):
-No registration with HSA, need to complete Class A Exemption list;
-Dealer's license application;
-Essential principles;
-QMS certification (ISO13485; MDSAP or DoC to a QMS).
Class B, C, D:
-Abriged route - using overseas regulatory evidence for B, C, D;
-Immediate Class B (IBR) and Class C mobile applications only;
-Expedited routes: Class C (ECR) and Class D (EDR).
Chile
Regulation
[ISP]
Instituto de Salud Publica
Sanitary Code and Decree 825/98.
Regulatory authority
Instituto de Salud Publica - ISP: Public Health Institute
National Agency for Medical Devices - ANDID
Classification
Class I
Class II
Class III
Class IV
Class A IVD
Class B IVD
Class C IVD
Class D IVD
Overseas approvals
Not specified (Healthcare providers likely prefer [EU MDD/MDR]
[EU IVDD/IVDR] or
[21CFR]
A regulatory pathway is underway.
Voluntary registration is recommended.
Representative
Legal representative
Must be appointed; represents the foreign manufacturer to ensure compliance and liaise with authorities for registration with [ISP]
Application (in-country manufacturer)
Conformity Assessment
Registration on ISP
Application (overseas manufacturer)
Conformity Assessment
Registration on ISP;
All documentation in Spanish;
(healthcare providers likely prefer CE or FDA approved devices; voluntary registration is recommended)
Colombia
Regulation
[INVIMA]
Decree 4725/2005
Regulatory authority
National Food and Drug Surveillance Institute- INVIMA.
Classification
Class I
Class IIa
Class IIb
Class III
Class I IVD
Class II IVD
Class III IVD
Overseas approvals
[EU MDD/MDR]
[EU IVDD/IVDR]
[TGA MDR]
[21CFR]
[HC MDR]
[PMDA] Japan
QMS:
BS EN ISO 13485:2016+A11:2021 certificates
Representative
Legal representative
Must be appointed; represents the foreign manufacturer to ensure compliance and liaise with authorities for registration with [INVIMA]
Application (in-country manufacturer)
Class I and IIa: immediate approval - registo sanitario is automatic; can operate immediately; must still submit documentation and answer any INVIMA queries.
Class IIb and III: must obtain registration certificate - registo sanitario and permission for commercialisation prior to placing on the market.
Application (overseas manufacturer)
Class I and IIa: immediate approval; registo sanitario is automatic; can operate immediately; must still submit documentation and answer any INVIMA queries.
Class IIb and III: full review and approval needed; must obtain registration certificate - registo sanitario and permission for commercialisation.
All documentation in Spanish
Switzerland
Regulation
[MedDO]
Switzerland Medical Devices Ordinance of 1 July 2020 (SR 812.213)- Switzerland
EU 2017/745 Medical Device Regulation is directly applicable
[IvDO]
Switzerland In Vitro Diagnostic Medical Devices Ordinance of 26 May 2022 (SR 812.219) - Switzerland
EU 2017/746 Medical Device Regulation is directly applicable
Regulatory authority
Swissmedic
Classification
Aligned with the [EU MDR] / [EU IVDR]
Class I / Class A IVD
Class IIa / Class B IVD
Class IIb / Class C IVD
Class III / Class 4DIVD
Overseas approvals
[EU MDR]
[EU IVDR]
Representative
Swiss Authorised Representative - CH-REP
Required for non-Swiss manufacturers to ensure compliance, liaison with Swissmedic and is responsible for PMS
Application (in-country manufacturer)
[MedDO] and [IvDO] are aligned with [EU MDR] and [EU IVDR]
CE mark is obtained from a EU Notified Body (Switzerland does not have a separate NB list) followed by registration with Swissmedic via Swissdamed.
Application (overseas manufacturer)
Must obtain CE-mark as per [EU MDR] and [EU IVDR].
Followed by Submission to Swissmedic done via the CH-REP.
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