VEMERIX
Medical Equipment
REGULATORY GUIDES

Market-entry requirements, made decision-ready.

Jurisdiction-specific guidance on classification, registration, labeling, UDI, evidence packs and compliance boundaries.

China Class II UDI production clock decision tree comparing Announcement 21 remaining Class II, 2023 No. 22 third-batch 103 varieties, and Announcement 15 exemptions
Regulatory Guide
Does This China Class II Shipment Need a UDI YetAn incoming-inspection and regulatory-clock guide for international distributors, OEM/private-label buyers, and hospital procurement leads evaluating Chinese Class II sterile device shipments, Announcement 21 remaining-variety deadlines, the 103 third-batch catalogue, and Announcement 15 exemptions on 18 September 2026.September 18, 2026 · 16 min read
COFEPRIS Mexico medical device market placement and regulatory compliance roadmap under Ley General de Salud Articles 262 and 376, RIS Article 83 risk classes, 2010/2012 equivalence, and 18 July 2025 Option F lineamientos
Regulatory Guide
How to Place a Medical Device on the Mexican Market in 2026: Registro Sanitario versus 2010 FDA/Canada and 2012 Japan Equivalence Agreements versus Option F Abbreviated Pathway under the 18 July 2025 Lineamientos, IMDRF Management Committee versus MDSAP for GMP Certificates Only, Homoclave COFEPRIS-04-050 Still Physical, the 20 August 2026 Visor, Official LFD Article 195-A Fees, and Why CE / 510(k) / NMPA / MDSAP Do Not Replace a Mexican Sanitary RegistrationAn operational regulatory guide for international medical device distributors, OEM buyers, and foreign manufacturers placing sterile single-use devices on the Mexican market under Ley General de Salud Articles 262 and 376, RIS Article 83 risk classes, the 2010 FDA/Canada and 2012 Japan equivalence agreements, and the 18 July 2025 Option F abbreviated pathway.September 7, 2026 · 22 min read
Japan PMDA medical device market placement and regulatory compliance roadmap under PMD Act Articles 23-2 and 23-2-17, FMR Article 23-2-4, and MHLW Ordinance 169
Regulatory Guide
How to Place a Medical Device on the Japanese Market in 2026: Marketing Authorization Holder versus Designated MAH under PMD Act Articles 23-2 and 23-2-17, Foreign Manufacturer Registration under Article 23-2-4 versus Drug Accreditation, Todokede versus Ninsho versus Shonin, Ordinance 169 and MDSAP, Official Yen Fees, and Why CE / 510(k) / NMPA / HSA Do Not Replace a Japanese LicenceAn operational regulatory guide for international medical device distributors, OEM buyers, and foreign manufacturers placing sterile single-use devices on the Japanese market under PMD Act Articles 23-2, 23-2-4, and 23-2-17, MHLW Ordinance 169, and official PMDA user-fee schedules.September 5, 2026 · 15 min read
South Korea MFDS medical device market placement and regulatory compliance roadmap under Medical Devices Act and Act No. 21263
Regulatory Guide
How to Place a Medical Device on the Korean Market in 2026: Import Business Permission versus Item Notification, Certification or Approval, KGMP and QMS Conformity Recognition after Act No. 21263, Official Fees under Enforcement Rule Article 65, and Why CE / 510(k) / NMPA / HSA Do Not Replace an MFDS LicenceAn operational regulatory guide for international medical device distributors, OEM buyers and manufacturers placing sterile single-use devices on the Republic of Korea market under the Medical Devices Act, Enforcement Rule Article 65 fees, and Act No. 21263 QMS conformity rules.September 3, 2026 · 14 min read
Infographic diagram of Singapore Health Sciences Authority (HSA) medical device market placement framework: SMDR product registration, Class A notification, Singapore Registrant mandate, dealer licences, GN-15 R13 evaluation routes, and 2026 official fees.
Regulatory Guide
How to Place a Medical Device on the Singapore Market in 2026: SMDR versus Class A Notification versus Dealer Licence versus Registrant, GN-15 R13 Evaluation Routes and Malaysia MDA Reliance, Official Fees as of 26 March 2026, and Why CE / 510(k) / NMPA Do Not Replace an HSA ListingA definitive, decision-led guide for international manufacturers and Singapore distributors: navigating Singapore Health Sciences Authority (HSA) medical device registration, SMDR listings, Class A SHARE notifications, Registrant mandates, dealer licences, GN-15 R13 evaluation pathways, and 2026 fee cards.September 1, 2026 · 14 min read
VEMERIX regulatory guide cover illustrating the 2026 Health Canada medical device market placement framework: Medical Device Licence (MDL) for Class II–IV under SOR/98-282 s 26, Medical Device Establishment Licence (MDEL) under GUI-0016, MDSAP QMS filing condition, Schedule 1 risk classification, April 2026 fees including private-label MDL (CAD 179), MDALL verification limits, and SOR/2026-110 Phase 2 coming-into-force rules.
Regulatory Guide
How to Place a Medical Device on the Canadian Market in 2026: Medical Device Licence versus Medical Device Establishment Licence versus Class I, MDSAP as a Licence Condition not a Substitute, Official Fees as of 1 April 2026, and Why SOR/2026-110's Coming-into-Force Date Is Counted from Registration not from the MDCP BulletinAn operational decision guide for international medical-device distributors, private-label/OEM buyers, and overseas manufacturers: navigating Health Canada Medical Device Licences (MDL) under SOR/98-282 s 26, Medical Device Establishment Licences (MDEL) under GUI-0016 Table 1, the mandatory MDSAP quality filing condition, Schedule 1 risk classification, official 1 April 2026 fees including the private-label MDL, MDALL versus MDEL listing verification boundaries, and the SOR/2026-110 modernization coming-into-force timeline.August 30, 2026 · 22 min read
VEMERIX regulatory guide cover illustrating the 2026 Australian medical device market placement workflow: TGA ARTG inclusion under the Therapeutic Goods Act 1989, Australian Sponsor requirements, Manufacturer Evidence pre-approval, TGA classification (Classes I–III), Comparable Overseas Regulator (COR) pathways, and class-phased AusUDID requirements.
Regulatory Guide
How to Place a Medical Device on the Australian Market in 2026: ARTG Inclusion versus Australian Sponsor versus Manufacturer Evidence, TGA Classification, Comparable Overseas Regulator Evidence, and Why 1 July 2026 UDI Starts Only After You Know the TGA ClassAn operational decision guide for international distributors, private-label/OEM buyers, and overseas manufacturers: navigating Australian Register of Therapeutic Goods (ARTG) inclusion under the Therapeutic Goods Act 1989, the Australian sponsor mandate, Manufacturer Evidence pre-approval, TGA risk classification (Classes I, IIa, IIb, III), Comparable Overseas Regulator (COR) pathways, July 2026 fee schedules, and the class-phased 1 July 2026 Unique Device Identification (AusUDID) rollout.August 29, 2026 · 20 min read
VEMERIX regulatory guide cover showing the Saudi Arabia medical device market placement workflow: SFDA MDMA under Law M/54, MDS-G008 risk classification (Classes A–D), May 2025 fee schedule, MDS-G028 bundling rules (3 May 2026), Authorized Representative mandate via GHAD, and MDS-REQ 5 shipment clearance.
Regulatory Guide
How to Place a Medical Device on the Saudi Market in 2026: MDMA versus Authorized Representative versus Establishment License, SFDA Classes A–D, 2025 Fees, and the May 2026 Bundling RulesAn operational decision guide for international distributors, private-label/OEM buyers, and overseas manufacturers: navigating the Kingdom of Saudi Arabia's MDMA requirements under Law M/54, the Technical File Assessment route, SFDA Classes A–D (MDS-G008), the May 2025 fee schedule, the 3 May 2026 bundling criteria (MDS-G028), Authorized Representative mandates, importer establishment licensing, and port-clearance verification.August 25, 2026 · 18 min read
VEMERIX regulatory guide cover showing the Great Britain medical device market placement workflow: CE recognition timelines to 2028 and 2030, UKCA requirements under UK MDR 2002, UK Responsible Person mandates, MHRA DORS registration and 2026 annual fees, post-market surveillance rules in force from June 2025, and the Northern Ireland EUDAMED framework.
Regulatory Guide
How to Place a Medical Device on the Great Britain Market in 2026: When a Valid CE Mark Is Enough, When UKCA Is Required, Appointing a UK Responsible Person, MHRA Registration, and the June 2025 PMS Rules That Already ApplyAn operational decision guide for international distributors, OEM buyers, and non-UK manufacturers: navigating Great Britain's CE-recognition timelines (2028 vs 2030), UKCA requirements under UK MDR 2002, UK Responsible Person mandates, DORS registration and 2026 fees, Northern Ireland EUDAMED rules, and the in-force June 2025 post-market surveillance obligations.August 23, 2026 · 19 min read
VEMERIX regulatory guide cover showing the step-by-step verification workflow for medical device Certificates of Free Sale, FDA FECV validation, EU MDR Article 60 requirements, UK MHRA checks, and China NMPA export certificate rules.
Regulatory Guide
How to Verify a Certificate of Free Sale for a Medical Device: A Distributor's Guide to CFS and Export Certificates, Checking Issuing Authorities (FDA, EU, UK MHRA, NMPA) and Spotting Red FlagsA practical field-by-field verification guide for medical device export certificates: authenticating FDA CFGs via FECV, validating EU MDR Article 60 certificates, checking UK MHRA free-sale documents, navigating China's May 2026 export certificate reforms, and matching scope to your RFQ.August 21, 2026 · 19 min read
VEMERIX regulatory guide cover showing a sterile tube of silicone scar gel, silicone sheeting segment, and US EU China regulatory decision documentation.
Regulatory Guide
Silicone Scar Gel Classification and Claim Substantiation: A US (FDA), EU and China (NMPA) Decision Matrix for Distributors and OEM BuyersQualifying a silicone scar gel or sheeting product for international markets requires navigating strict claim-by-claim classification rules across the US (FDA Class I under 21 CFR 878.4025), Europe (EU MDR Class I device vs Cosmetic Regulation boundary), and China (NMPA Class II medical device filing)—where permitted intended-use language, Cochrane evidence certainty, and ISO 10993 biocompatibility requirements set the boundary between compliant commercialization and regulatory rejection.August 5, 2026 · 14 min read
VEMERIX regulatory guide cover showing a US, EU and China regulatory decision matrix for hypochlorous acid (HOCl) disinfectants.
Regulatory Guide
Hypochlorous Acid (HOCl) Disinfectant Classification: A US, EU and China Regulatory Decision Matrix for Medical-Device and Hygiene-Product BuyersProcuring hypochlorous acid (HOCl) disinfectants internationally requires recognizing that regulatory classification is governed by intended-use claims, concentration, and application site rather than chemical identity—navigating the US EPA pesticide vs FDA liquid sterilant split under PRN 98-2, ECHA Biocidal Products Regulation (BPR) active substance rules in Europe, and China's weixiaozheng hygiene licensing system.August 3, 2026 · 15 min read
An on-brand VEMERIX report cover: a single dressing shown as a ladder of regulatory classes, rendered in accent-pink linework on a clean off-white field.
Deep ResearchRegulatory Guide
The Line That Decides the Class: How a Wound Dressing's Claim — Not Its Chemistry — Sets Its Regulatory Class in the US, EU and ChinaIn wound and skin care the label claim, not the material, sets the regulatory class — and because most of the category is 510(k)-exempt in the United States, the public clearance record systematically under-describes who actually supplies it. A primary-source read of 31 FDA product codes, EU MDR Rule 4 and NMPA's 2022 catalogue change.July 27, 2026 · 27 min read