Jurisdiction Comparison Tool

Select 2–4 jurisdictions from 14 markets to compare their medical device regulatory frameworks side-by-side.

Select Markets (4 of 4 max)

Category	🇸🇬 HSA HSA Singapore	🇺🇸 FDA FDA USA	🇦🇺 TGA TGA Australia	🇪🇺 EU EU MDR
Classification System	Class A — Low risk Class B — Low-moderate risk Class C — Moderate-high risk Class D — High risk 16 classification rules (GN-13)	Class I — Low risk Class II — Moderate risk Class III — High risk 16 medical specialty panels; ~1,700 device types	Class I — Low risk Class IIa — Low-medium risk Class IIb — Medium-high risk Class III — High risk AIMD — Active implantable IMDRF-aligned classification rules	Class I — Low risk Class IIa — Medium risk Class IIb — Medium-high risk Class III — High risk 22 classification rules (Annex VIII)
Regulatory Body	Health Sciences Authority (HSA) — Medical Devices Branch (MDB)	Food and Drug Administration (FDA) — Center for Devices and Radiological Health (CDRH)	Therapeutic Goods Administration (TGA) — Dept. of Health and Aged Care	EU Notified Bodies (NBs) — European Commission oversight; EUDAMED registry
Primary Registration System	PRISM — Product Registration and Information for Safety Management	eSTAR / FURLS — Electronic Submissions Template and Resource; FDA Unified Registration and Listing System	TBS (TGA Business Services) — ARTG (Australian Register of Therapeutic Goods)	EUDAMED — European Database on Medical Devices
Recognition of Foreign Approvals	Recognises FDA, EU, TGA, Health Canada — Abridged pathway via SBA/comparable authority	Limited — primarily own pathway — MDSAP audits accepted; no direct foreign approval recognition	Recognises FDA, EU, Health Canada, PMDA — Comparable Overseas Authority (COA) pathway	No direct foreign recognition — CE marking via Notified Body; MRA with select countries for audits
Approximate Timeline	Class A (low): 1–2 weeks Class B (med): 60–90 days Class C/D (high): 90–180 days Priority review: 60 days for Class C/D	Class I (low): Exempt or ~90 days Class II (med): 90–180 days (510k) Class III (high): 180 days–3 years (PMA)	Class I (low): ~4 weeks Class IIa/IIb (med): 3–6 months Class III/AIMD (high): 12–18 months	Class I (low): Immediate (self-declaration) Class IIa/IIb (med): 6–12 months Class III (high): 12–24 months
Approximate Fees	Application: SGD 560 Immediate: + SGD 1,000–3,340 Abridged: + SGD 2,010–6,250 Full: + SGD 3,900–12,000	510(k): USD 26,067 De Novo: USD 173,782 PMA: USD 579,272 Small biz: 510(k) $6,517, PMA $144,818	Class I: AUD 621 Class IIa/IIb: AUD 1,187 (+$4,700 if audit) Class III/AIMD: AUD 18,818 (incl. mandatory audit)	Class I: EUR 5,000–15,000 (self-cert + EU Rep) Class IIa: EUR 25,000–80,000 (NB + EU Rep) Class IIb: EUR 50,000–150,000 (NB + EU Rep) Class III: EUR 100,000–500,000+ (NB + scrutiny)
QMS Standard Required	ISO 13485 required (Class B/C/D) — GMP inspections for Class C/D	21 CFR 820 (QMSR) — aligning with ISO 13485 — FDA QSR inspections mandatory	ISO 13485 mandatory (Class IIa+) — Self-assessment for Class I only	ISO 13485 or equivalent (all classes) — NB audits; unannounced for Class IIb/III
Clinical Evidence Requirements	Low risk: Literature review sufficient High risk: CER mandatory; prospective clinical investigation for Class D	Low risk: Bench data; predicate equivalence High risk: Clinical trials often mandatory (IDE study)	Low risk: Basic safety data High risk: Full clinical evaluation; investigation may be required	Low risk: Clinical evaluation mandatory (all classes) High risk: Clinical investigation often required; PMCF + SSCP
UDI Required	Planned — Implementation roadmap in progress	Yes — GUDID database; phased implementation complete	Yes — IMDRF UDI aligned; phased rollout	Yes — EUDAMED UDI database; MDR Article 27
Post-Market Surveillance	Required — Mandatory incident reporting; PMS plan for Class C/D; annual safety updates for Class D	Required — MDR reporting (30-day/5-day); device tracking for Class III; post-approval studies	Required — Mandatory reporting within 30 days; PMS plan for Class IIa+; PSURs	Required — Most stringent globally; PSUR, PMCF, SSCP; EUDAMED vigilance; MDR Articles 87–92

Key Similarities

•All 14 jurisdictions use risk-based classification to drive submission pathways, fees, and clinical evidence requirements.
•ISO 13485 (or local equivalent) is the predominant QMS standard across all major markets.
•Post-market surveillance and adverse event reporting obligations exist in all jurisdictions, with varying levels of enforcement.
•ISO 14971 risk management and IEC 60601 electrical safety standards are referenced across virtually all frameworks.
•ASEAN markets (Singapore, Thailand, Malaysia, Vietnam, Philippines) share harmonised classification rules and mutual recognition.

Key Differences

•NMPA China requires full domestic review with no foreign approval recognition — the most restrictive market for foreign manufacturers.
•Hong Kong MDACS is listing-based with no registration fees — the lightest regulatory touch among the 14 jurisdictions.
•PMDA Japan has the longest timelines for high-risk devices (up to 60 months) and may require Japanese-specific clinical data.
•EU MDR is the only framework requiring a public Summary of Safety and Clinical Performance (SSCP) for Class III devices.
•FDA is unique in using a 510(k) predicate-based substantial equivalence pathway not available elsewhere.
•Fee structures vary enormously: from HKD 0 (Hong Kong listing) to EUR 300,000+ (EU MDR Class III Notified Body fees).
•UDI implementation varies widely: mandatory in FDA/EU/NMPA/MFDS/PMDA, planned in HSA/HC/Thailand/Malaysia, and not required in Vietnam/Philippines/Hong Kong.

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Data is indicative and for reference purposes only. Always verify current requirements with the relevant regulatory authority. Last reviewed: March 2025.