Medtech: international market access and regulatory strategy

Competent authority

SAHPRA

Estimated registration duration

1: Establishment licence: ~6-8 months
2: Product registration: ~2 months

MSDAP program

Affiliate

Applicable regulations (non-conclusive)

Medicines and Related Substances Act 101 of 1965

Risk-based classification

MD/IVD: A - low / B - medium / C - high / D - very high

Assessment routes (without clinical devices)

1: Establishment licence
2: Product registration with reliance on approval from other recognised jurisdictions

Mutual recognition agreements / collaborations

Reliance/verification pathway on recognised regulators’ approvals (AU, US, EU, BR, CA, JP) and WHO PQ (IVD)

Labelling requirements

Language requirements: English / manufacturer & SA licence holder

QMS requirements

ISO 13485

Requirements foreign manufacturers

South African establishment licence holder

Validity duration of access

5 years

Competent authority

ANMAT

Estimated registration duration

Class I: 2-4 months
Class II: 6-9 months
Class III: 9-15 months
Class IV: 12-18 months
IVD (A-D): 6-15 months 

MSDAP program

Affiliat

Applicable regulations (non-conclusive)

Disposición 2318/2002 (classification, labelling, registration, GMP) Disposición 727/2013 (registration of medical devices)

Risk-based classification

MD:I - low, II - medium, III - high, IV - very high
IVD: A - low, B - medium C - high, D - very high

Assessment routes (without clinical devices)

Class I: notification / sworn declaration
Class II: intermediate / Declaration of Conformity + technical data
Class III & Class IV: full technical review / comprehensive route

Class A: notification/ listing
Class B: simplified technical review Class C: full technical assessment Class D: comprehensive evaluation and testing/audit possible

Mutual recognition agreements / collaborations

ANVISA (Brazil) and ANMAT (Argentina)

Labelling requirements

Language requirements: Spanish. Use metric units for quantities, volumes and measurements 

QMS requirements

Good Manufacturing Practices (GMP) / Disposición 191/99 (analogues to ISO 13485)

Requirements foreign manufacturers

Local Authorised Representative (LAR) 

Validity duration of access

5 years for MD and IVD

Competent authority

TGA

Estimated registration duration

Class I: immediately 

Class Is/Im/IIa/IIb: 2-4 months 

Class III: 4-8 months 
(longer if full TGA conformity assessment is needed)

MSDAP program

Member

Applicable regulations (non-conclusive)

Therapeutic Goods Act 1989 / Therapeutic Goods (Medical Devices) Regulations 2002

Risk-based classification

MD: I, Is (sterile), Im (with measuring function) (low) / IIa, IIb (medium) / III (high)
IVDR: I-IV (low to high)

Assessment routes (without clinical devices)

With EU CE Certificate
Class I: self declaration / Class II: ARTG inclusion with CE/MDSAP / Class III: ARTG inclusion and TGA audit

Without EU CE Certificate
Class I: still self declaration / Class Is, Im, IIa, IIb, III: request TGA conformity assessment which requires complete QMS 
assessment, TD review and labelling  and instructions for use compliant wit Australian Essential Principals

For IVDRs same approach as referenced above is applied

Mutual recognition agreements / collaborations

EU, United Kingdom, New Zealand, Singapore

Labelling requirements

Language requirements: English

QMS requirements

Yes, ISO 13485

Requirements foreign manufacturers

Australian Sponsor

Validity duration of access

Unlimited

Responsible authority

ANVISA

Estimated registration duration

Class I: 30-90 days 
Class II: 60-180 days
Class III: 360-720 days 
Class IV: 540-1080 days

MDSAP program

Member

Applicable regulations (non-conclusive)

Medical equipments & material for health use: Resolution RDC 751/2022 
IVD: Resolution RDC 830/2023
GMP: Resolution RDC 665/2022
GMP (administrative procedures): Resolution RDC 687/2022

Risk-based classification

I, II, III, IV

Assessment routes (without clinical devices)

Class I & II: Cadastro (notification) 
Class III & IV: Registro (full registration

Mutual recognition agreements / collaborations

No

Labelling requirements

ANVISA registration number
Intended use 
Importer details

QMS requirements

Yes, B-GMP (valid 2 years) or B-GMP with MDSAP (valid 4 years)

Requirements foreign manufacturers

Brazilian Registration Holder (BRH)

Validity duration of access

Class I and II: indefinity / Class III and IV: 10 years 

Competent authority

Health Canada

Estimated registration duration

Class I: immediately 

Class II: ~15-40 days

Class III: ~75 days

Class IV: ~90 days
(longer if deficiency letter is issued)

MSDAP program

Member

Applicable regulations (non-conclusive)

Food and Drugs Act / Medical Devices Regulations (SOR/98-282)

Risk-based classification

I, II, III, IV

Assessment routes (without clinical devices)

Class I devices / IVD: no license required but Medical Device Establishment License (MDEL) for manufacturer
or importer

Class II, III, IV devices / IVD: Medical Device License (MDL) + Class II: safety & effectiveness evidence, labelling, QMS certification

Class III–IV: full technical documentation, clinical evidence, risk-benefit analysis

Mutual recognition agreements / collaborations

MRAs with the EU and Switzerland → recognition of QMS audit/certification results

Labelling requirements

Labelling in English/French

QMS requirements

ISO 13485, ≥ Class II MDSAP

Requirements foreign manufacturers

For direct import MDEL required

Validity duration of access

MDL: unlimited / MDEL: renewed annually

Competent authority

NMPA CMDE

Estimated registration duration

Class I: <5 days
Class II: 1-2years 
Class III: 2-3years

MSDAP program

N/A

Applicable regulations (non-conclusive)

SAMR Decree 47, 48, 53, 54 NMPA Order No. 739

Risk-based classification

I, II, III

Assessment routes (without clinical devices)

Class I: notification
Class II: registration with NMPA and technical review Class III:  strictest review which requires NMPA approval

Mutual recognition agreements / collaborations

Malaysia – China Medical Device Regulatory Reliance Pilot (2025) (pilot for IVD only)

Labelling requirements

Language requirements: simplified Chinese is mandatory / registration filing number / Legal Agent address /
intended use / warnings, contraindications, precautions

QMS requirements

Yes, ISO 13485 or C-GMP

Requirements foreign manufacturers

China Agent / Legal Agent

Validity duration of access

5 years for class II/III products, renewal must be filed 6-12 months before expiry

Competent authority

MFDS

Estimated registration duration

Class I (non-sterile, non-measuring): ~2-4 weeks
Class I (sterile or measuring): ~3-4 months Class II (with predicate/equivalent): ~6-9 months
Class II (no predicate/new type): ~9-12 months Class III: ~12-15 months
Class IV: ~15-18 months

MSDAP program

Affiliate

Applicable regulations (non-conclusive)

Medical Devices Act (MDA)

Risk-based classification

MD :
I - low
II - medium
III - high
IV - very high

Assessment routes (without clinical devices)

Class I: notification/pre-market notification
Class I (sterile or measuring): similar to Class II
Class II (with predicate): certification/simplified review Class II (new): pre-market approval (full review/SER) Class III & IV: full approval/SER/technical review

Mutual recognition agreements / collaborations

Korea – Singapore MRA on GMP for medicinal products Switzerland – Korea (MFDS) GMP MRA (medicinal products)

Labelling requirements

Language requirements: Korean

QMS requirements

KGMP requirement (Korean Good Manufacturing Practice)

Requirements foreign manufacturers

Korean License Holder (KLH) 

Validity duration of access

5 years

Competent authority

FDA (CDRH, CDER, CBER)

Estimated registration duration

510(k): ~90-180 days / De Novo: ~180 - 270 days / PMA: ~360- 540 days 

MSDAP program

Participant

Applicable regulations (non-conclusive)

FD&C Act (Title 21):
21 CFR 820 (Quality System Regulation*)
21 CFR 807 (Registration and Listing)
21 CFR 814 (Premarket Approval)
21 CFR 812 (Investigational Device Exemption)
21 CFR 801 (Labelling)
21 CFR 830 (UDI)
21 CFR 803 (Medical Device Reporting)
21 CFR 806 (Corrections and Removals)
*to be replaced by QMSR in alignment with ISO 13485

Risk-based classification

I, II, III

Assessment routes (without clinical devices)

Class I and II  Premarket Notification (510(k), 21 CFR 807 Subpart E) or DeNovo (21 CFR 814) 
Class III Premarket Approval (PMA, 21 CFR 814 )
Note: Manufacturers need to register their establishment with the FDA anually (21 CFR 807) and  list their devices with FDA

Mutual recognition agreements / collaborations

No

Labelling requirements

Latex / Rx Only / UDI

QMS requirements

Yes, cGMP and ISO 13485

Requirements foreign manufacturers

US Agent (serves as FDAs primary contact)

Validity duration of access

Unlimited

Competent authority

European Commission (legislator and coordinator)

National Competent Authorities (e.g. BfArM, ANSM, AEMPS): supervise medical devices in territory
Notified Bodies (e.g. BSI, Dekra, DNV): independent, designated conformity assessment organisations approved 
and monitored by NCAs and European Commission

Estimated registration duration

Class I: <5 days
Class I*, IIa/IIb, III: ~270-720 days (currently)

MSDAP program

Observer

Applicable regulations (non-conclusive)

MDR EU 2017/745  /  IVDR EU 2017/746

Risk-based classification

MD: I, I*, IIa, IIb, III / VD: A, B, C, D

Assessment routes (without clinical devices)

Class I: self-declaration
Class I*, IIa/IIb: 3rd party review
Class III: 3rd party review (design examination) Class A: self-declaration
Class A sterile: 3rd party review
Class B: 3rd party review

Mutual recognition agreements / collaborations

No

Labelling requirements

CE mark, UDI, EU Representative, Importer, language of the respective member state 

QMS requirements

Yes, Annex IX of MDR (EU) 2017/745 and IVDR IVDR (EU) 2017/746

Requirements foreign manufacturers

Authorised Representative

Validity duration of access

Usally 5 years for class I*, IIa, IIb, III since often connected to TD certificates issued by NB or when major changes occur

Competent authority

Danish Medicines Agency (Lægemiddelstyrelsen)

Estimated registration duration

Class I: <5 days / Class I*, IIa/IIb, III: ~270-720 days (currently)

MSDAP program

Observer

Applicable regulations (non-conclusive)

MDR (EU) 2017/745 / IVDR (EU) 2017/746 / Danish Act no. 682 of 29 May 2023

Risk-based classification

MD: I, I*, IIa, IIb, III / IVD: A, B, C, D

Assessment routes (without clinical devices)

Class I: self-declaration
Class I*, IIa/IIb: 3rd party review Class III: 3rd party review (design examination)
Class A: self-declaration
Class A sterile: 3rd party review Class B: 3rd party review
Class C: 3rd party review
Class C (CDx): 3rd party review + EMA/CA consultation
Class D (CS): 3rd party review + EU reference laboratory
Class D: 3rd party review + EU reference laboratory + expert consultation Class D (CDx): 3rd party review + EMA/CA consultation + EU reference laboratory + expert consultation

Mutual recognition agreements / collaborations

No

Labelling requirements

Labels must be in Danish, Greenlandic or English

QMS requirements

Yes, Annex IX of MDR (EU) 2017/745 and IVDR IVDR (EU) 2017/746

Requirements foreign manufacturers

Authorised Representative

Validity duration of access

Usally 5 years for class I*, IIa, IIb, III since often connected to TD certificates issued by NB or when major
changes occur

Competent authority

CDSCO under the Ministry of Health & Family Welfare

Estimated registration duration

6-9 months

MSDAP program

N/A

Applicable regulations (non-conclusive)

Drugs & Cosmetics Act, 1940 & Rules 1945; Medical Devices Rules, 2017 (as amended) (MDR 2017)

Risk-based classification

A - low
B - medium
C - high
D - very high

Assessment routes (without clinical devices)

Class A/B: licensed via State Licensing Authority (SLA)
Class C/D: licensed via Central Licensing Authority (CLA)

Mutual recognition agreements / collaborations

No

Labelling requirements

Labels must comply with Chapter VI of MDR 2017 (Medical Devices Rules, 2017)

QMS requirements

ISO 13485

Requirements foreign manufacturers

Indian Authorised Representative / local legal entity

Validity duration of access

5 years

Competent authority

AMAR

Estimated registration duration

~120 working days for standard routes (device-dependent) / Class I via declaration route is administrative only

MSDAP program

Affiliat

Applicable regulations (non-conclusive)

Medical Equipment Law (AMAR, Ministry of Health)

Risk-based classification

Relies on the risk class of a recognised reference market

Assessment routes (without clinical devices)

Declaration route (Class I MD/IVD, mandatory since 1 January, 2024)
Normal route (leverages reference-country approval)
Fast-track route (accelerated when strong reference approval criteria are met)

Mutual recognition agreements / collaborations

EU - Israel ACAA (Agreement on Conformity Assessment and Acceptance of Industrial Products) covers some medical devices

Labelling requirements

Professional-use devices: labelling/IFU may be English-only. Home-use devices: labelling/IFU must be in
Hebrew, Arabic and English. Add importer/IRH details, origin and standard identification/warnings.

QMS requirements

QMS such as ISO 13485

Requirements foreign manufacturers

Israel Registration Holder (IRH)

Validity duration of access

5 years or 3 years for implants

Competent authority

MHLW (legislator)
PMDA

Estimated registration duration

Notification: 30-60 days / 3rd party certification: 90-180 days / approval: 360-540 days

MSDAP program

Member

Applicable regulations (non-conclusive)

PMD Act

Risk-based classification

MD: I: general (low risk)
I: controlled (moderate risk)
III: specially controlled (higher risk)
IV: specially controlled (highest risk, life-supporting/implantable)
IVD: general (low risk, e.g., specimen controlled (moderate risk) / designated controlled (require 3rd party certification) / highly controlled (high risk, e.g., HIV, hepatitis tests)

Assessment routes (without clinical devices)

Class I  / general - self-declaration - notification (Todokede)
Class II / controlled - self-declaration - notification
Class II (designated) - 3rd party certification body - certification (Ninsho)
Class III & IV devices / highly controlled IVD - PMDA review + MHLW approval - approval (Shonin)

Mutual recognition agreements / collaborations

PMDA staff stationed at the foreign agency: Switzerland, United States & Canada / EU (focus on QMS/GMP)

Labelling requirements

MAH name and address / Marketing Authorisation number

QMS requirements

Yes, PMD Act and Japanese QMS Ordinance (Ministerial Ordinance No. 169 of 2004, amended multiple times) 

Requirements foreign manufacturers

Marketing Authorisation Holder (MAH)

Validity duration of access

Unlimited

Competent authority

Medical Device Authority (MDA)

Estimated registration duration

Class A: 4-6 weeks / Class B: 4-6 months / Classe C/D: 6-9 months

MSDAP program

Affiliate Member

Applicable regulations (non-conclusive)

Medical Device Act 2012 (Act 737) 
Medical Device Regulations 2012

Risk-based classification

A (low) / B (low-moderate) / C (moderate-high) / D (high)

Assessment routes (without clinical devices)

Class A: self declaration
Class B: Conformity Assessment Body (CAB)
Class C: Conformity Assessment Body (CAB)
Class D: Conformity Assessment Body (CAB)
CAB checks QMS (ISO 13485, technical documentation, safety and performance evidence)

Mutual recognition agreements / collaborations

China (Medical Device Regulatory Reliance / Mutual Recognition for IVD) 
Singapore (Regulatory Reliance Pilot*) *1 September, 2025-28 February, 2026

Labelling requirements

UDI encouraged, but not required. Name and address of Local Registration Holder (LRH)
Language requirements: English or Bahasa Malaysia (Malay)

QMS requirements

Yes, QMS (ISO 13485 or similar)

Requirements foreign manufacturers

Local Authorised Representative (LAR) 

Validity duration of access

Registration valid for 5 years

Competent authority

COFEPRIS

Estimated registration duration

Class I: ~3-8 months
Class II: ~2-5 months
Class III (equivalence if prior US/Canada/Japan approval): ~3-8 months 
Class III (standard): ~3-8 months or longer

MSDAP program

Affiliate

Applicable regulations (non-conclusive)

General Health Law (Ley General de Salud) / Reglement of Health Supplies (Reglamento de Insumos para la Salud)

Risk-based classification

MD:
I - low
II - moderate III - high

IVD:
mirrored (A/B/C/D often mapped to I/II/III for process)

Assessment routes (without clinical devices)

Standard route, 3rd party review (TPR), equivalence/abbreviated (“Equivalency”) route using foreign approvals (beginning September 2025)

Mutual recognition agreements / collaborations

As of 1 September, 2025, acceptance of regulatory evaluations from foreign jurisdictions (IMDRF/MDSAP members) as equivalency for registration

Labelling requirements

Language requirements: Spanish

QMS requirements

GMP standard NOM-241-SSA1-2021. MDSAP certification as equivalent to GMP

Requirements foreign manufacturers

Mexico Registration Holder (MRH) 

Validity duration of access

5 years

Competent authority

Medsafe

Estimated registration duration

WAND notification only

MSDAP program

N/A

Applicable regulations (non-conclusive)

Medicines Act 1981 / Medicines Regulations 1984 / Medicines (Database of Medical Devices) Regulations 2003

Risk-based classification

No classification

Assessment routes (without clinical devices)

WAND notification only

Mutual recognition agreements / collaborations

NZ maintains cooperation and an EU-NZ MRA

Labelling requirements

Manufacturer and sponsor on the label

QMS requirements

No formal pre-market approval, but evicence for a QMS (e.g. ISO 13485) will be requested.

Requirements foreign manufacturers

New Zealand sponsor

Validity duration of access

No expiry

Competent authority

MHRA

Estimated registration duration

Class I: <5 days
Class I*, IIa/IIb, III: ~270-720 days (currently) 

MSDAP program

Observer

Applicable regulations (non-conclusive)

UK Medical Devices Regulations 2002 (UK MDR 2002)*

*old framework. Amendments since Brexit → transitional rules. The full new framework is expected around 2025-2026. 

Risk-based classification

I, I*, IIa, IIb, III

Assessment routes (without clinical devices)

Class I: self-declaration
Class I*, IIa/IIb: 3rd party review
Class III: 3rd party review (design examination) Class A: self-declaration
Class A sterile: 3rd party review
Class B: 3rd party review
Class C: 3rd party review
Class C (CDx): 3rd party review + EMA/CA consultation
Class D (CS): 3rd party review + EU reference laboratory Class D: 3rd party review + EU reference laboratory + expert consultation
Class D (CDx): 3rd party review + EMA/CA consultation + EU reference laboratory + expert consultation

Mutual recognition agreements / collaborations

No

Labelling requirements

CE mark still accepted until June 30 2030, but UKCA mark may become mandatory

QMS requirements

Yes, QMS (ISO 13485) compliance is required, certified by an Approved Body (for UKCA) or Notified Body (for CE) 

Requirements foreign manufacturers

UK Responsible Person (UKRP)

Validity duration of access

UKCA certificate usually valid 5 years, issued by UK Approved Body / CE certificate still valid in GB until June 30, 2030

Competent authority

HSA

Estimated registration duration

Class A: listing notification only / Class B-D: few month to years

MSDAP program

Observer

Applicable regulations (non-conclusive)

Health Products Act 2007 and the Health Products (medical devices) Regulations 2010

Risk-based classification

A (low) / B (low-moderate), C (moderate-high) / D (high)

Assessment routes (without clinical devices)

Class A: exempt from product registration

Classes B, C and D: multiple routes:
full evaluation for devices without prior
approval from reference regulator
Abridged/expedited for devices already approved in refer-enced regulatory agencies (e.g. EU, US, Japan, Australia)

Immediate/expedited Class B (IBR) for Class B devices that meet certain criteria (e.g. prior approval, 3-year marketing history, no safety issues)
Priority revies scheme for devices in certain healthcare areas to accelerate market access

Mutual recognition agreements / collaborations

Singapore - Korea (GMP)
Singapore accepts devices approved by reference regulatory agencies e.g EU, US, Australia

Labelling requirements

Language requirements: English

QMS requirements

Yes, QMS (ISO 13485)

Requirements foreign manufacturers

Singapore-based registrant 

Validity duration of access

Unlimited, but annual retention fee

Competent authority

Swissmedic

Estimated registration duration

Class I devices & IVD Class A: ~2-3 weeks (Swissmedic registration)
Higher classes (IIa-III, IVD B-D): dependent on CE certificate (Swissmedic process ~1-2 months if complete)

MSDAP program

No

Applicable regulations (non-conclusive)

Medical Devices Ordinance (MedDO, SR 812.213) / In Vitro Diagnostics Ordinance (IvDO, SR 812.219)

Risk-based classification

I, I*, IIa, IIb, III

Assessment routes (without clinical devices)

Class I: Self-declaration
Class I*, IIa/IIb: 3rd party review
Class III: 3rd party review (design examination) Class A: self-declaration
Class A sterile: 3rd party review
Class B: 3rd party review
Class C: 3rd party review
Class C (CDx): 3rd party review + EMA/CA consultation
Class D (CS): 3rd party review + EU reference laboratory Class D: 3rd party review + EU reference laboratory + expert consultation
Class D (CDx): 3rd party review + EMA/CA consultation + EU reference laboratory + expert consultation

Mutual recognition agreements / collaborations

EU (expired since May 2021) 
US (draft legislation proposal)

Labelling requirements

CH mark, UDI, CH Representative, Importer, language requirements 

QMS requirements

Yes, Annex IX of MDR (EU) 2017/745 and IVDR IVDR (EU) 2017/746

Requirements foreign manufacturers

Swiss Representative

Validity duration of access

Usally 5 years or when major changes occur

Competent authority

TFDA

Estimated registration duration

Class I: ~1–2 months / Class II: ~7–12 months / Class III: ~8–12 months / new device: ~10–15+ months /
QSD (manufacturer QMS) ~6–8 months (not needed for Class I non-measuring/non-sterile

MSDAP program

Affiliate

Applicable regulations (non-conclusive)

Medical Devices Act (effective 2021) / Pharmaceutical Affairs Act

Risk-based classification

MD:
I - low
II - moderate III - high

IVD:
mirrored (A/B/C/D often mapped to I/II/III for process).

Assessment routes (without clinical devices)

Two stages:
1. Quality System / QSD Conformity Assessment
2. Product registration / device review
Class I: listing/registration
Class II-III: technical dossier review. New device (no predicate) might require fuller technical and clinical review. QSD assessment for Class I sterile/measuring and all Class II-III devices

Mutual recognition agreements / collaborations

Japan - Taiwan QMS / Medical Device Cooperation: Memorandum of Cooperation (MOC) on medical device Quality Management System (QMS) requirements

Labelling requirements

Language requirements: Traditional Chinese, license/listing number, manufacturer & Taiwan liscense holder

QMS requirements

QSD (Taiwan GMP) required for Class I sterile/measuring and all Class II-III devices

Requirements foreign manufacturers

Taiwan Agent/Local Registration Holder 

Validity duration of access

Product license: 5 years / QSD: 3 years