Medical electrical safety
Checks whether electrical safety is dossier evidence or a separate national product certificate.
Useful input: Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.
Free · No signup · Source-linked country rules
Does your medical device need another certificate or licence?
Classification is only the first layer. Check INMETRO, ANATEL, FCC, radio, electrical, metrology, radiation, import, environmental, and other country-specific requirements.
114 markets587 maintained routes736 official source links
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
What the checker evaluates
Twelve types of additional requirement
Only families present in a selected country’s maintained matrix are evaluated. Missing facts produce a conditional result, not a false “not required.”
Electromagnetic compatibility
Distinguishes medical EMC evidence from a separate conformity or supplier-declaration route.
Useful input: Active electronics, emissions, immunity, radio functions, and existing EMC reports.
Radio and spectrum approval
Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval.
Useful input: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.
Telecom network attachment
Checks whether equipment connected to a public network needs a separate terminal-equipment route.
Useful input: Public-network connection, terminal type, cellular or wired interfaces, and network function.
Electrical products and components
Evaluates the finished device, adapter, plug, charger, and battery against compulsory product lists.
Useful input: Every separately shipped adapter, charger, plug, battery, accessory, model, and household-use claim.
Legal metrology
Checks whether a clinical measuring function needs model approval or initial/periodic verification.
Useful input: Measured quantity, clinical decision use, units, accuracy claim, and whether the value drives treatment.
Ionizing radiation and radioactive sources
Separates product, supplier, import, facility, source-holder, and operator radiation obligations.
Useful input: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
Non-ionizing radiation
Checks laser, UV, ultrasound, RF, microwave, magnetic, acoustic, and other emitting-product controls.
Useful input: Energy type, wavelength or frequency, class, power, intended effect, and existing product reports.
Product-specific compulsory conformity
Checks listed products such as syringes, needles, gloves, condoms, implants, IUDs, and blood bags.
Useful input: Exact product category, sterile/single-use status, materials, variants, and applicable product standard.
Environmental and battery obligations
Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates.
Useful input: Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.
Halal and material-origin requirements
Distinguishes mandatory phase-ins from voluntary, tender-driven, or claim-driven halal certification.
Useful input: Device class, date, animal/human-derived materials, liquids, grafts, implants, prosthetics, and origin evidence.
Import conformity and shipment certificates
Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents.
Useful input: HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.
Browse by market
Medical device certification checkers by country
Each country page has its own tool, scheme pages, official source list, and links to classification, databases, fees, timelines, and registration planning.
Albania
3 routes · 5 official sources
Medical electrical and EMC evidence · AKEP radio equipment conformity notification/recognition · Radiation and legal-metrology authorization
Algeria
2 routes · 2 official sources
ANPP technical evaluation and conformity certificate · Import technical-conditions cahier des charges
Argentina
4 routes · 3 official sources
ANMAT electrical/EMC evidence · ENACOM homologation · RAMATEL
Armenia
8 routes · 12 official sources
Medical-device import (conformity) certificate · TR TS 004/2011 low-voltage equipment safety — medical devices excluded · TR TS 020/2011 electromagnetic compatibility of technical means
Australia
4 routes · 4 official sources
TGA electrical/EMC evidence · EESS · ACMA RCM
Austria
7 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · FMaG 2016 radio equipment market access
Azerbaijan
7 routes · 11 official sources
State registration by the Ministry of Health as the condition of import and sale · Legal metrology type approval and verification · Radio-frequency allocation permit and radio-equipment conformity certificate
Bahrain
4 routes · 7 official sources
NHRA Quality Assurance Certificate — CE marking or FDA Certificate to Foreign Government · TRA type approval for telecommunications equipment · SCE approval to use ionizing radiation sources
Bangladesh
2 routes · 1 official source
Medical electrical evidence · BTRC radio equipment approval/enlistment
Belarus
2 routes · 4 official sources
EAEU medical-device safety evidence · Encryption notification
Belgium
7 routes · 12 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Arrêté royal du 25 mars 2016 radio equipment conformity
Bolivia
5 routes · 5 official sources
AGEMED device registration dossier — quality-system certificate and technical documentation · AGEMED imported-device dossier — consularised certificate of free sale from the origin authority · ATT homologation — telecommunications and ICT equipment using the radioelectric spectrum
Bosnia and Herzegovina
9 routes · 17 official sources
BiH technical requirements for products and conformity assessment · ANNT electrical-equipment safety ordinance · ANNT electromagnetic-compatibility ordinance
Botswana
5 routes · 6 official sources
BoMRA electrical safety and EMC evidence in the device dossier · BOCRA communications equipment type approval · BOBS compulsory standards (Standards (Compulsory Standards) Regulations — Botswana Product Conformity Programme)
Brazil
5 routes · 6 official sources
INMETRO/SBAC conformity certificate · ANATEL certification and homologation · INMETRO legal-metrology type approval/verification
Bulgaria
8 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията
Cambodia
6 routes · 4 official sources
TRC type approval of radiocommunication, telecommunication and ICT equipment · TRC qualified-agent certificate for importation, supply and distribution · TRC import permit for restricted radiocommunication and ICT goods
Canada
4 routes · 5 official sources
Health Canada electrical/EMC evidence · ISED equipment certification/registration · Radiation Emitting Devices Act compliance
Chile
6 routes · 7 official sources
ISP NCh-norm documentary verification · Product-specific IEC and sterility certificates · SUBTEL short-range radio certificate or QR marking
China
5 routes · 5 official sources
NMPA electrical/EMC evidence · SRRC radio transmission equipment type approval · CCC
Colombia
4 routes · 4 official sources
INVIMA electrical/EMC evidence · CRC mobile-terminal homologation · Radiation-authority authorisation for controlled biomedical equipment
Costa Rica
3 routes · 4 official sources
Medical electrical evidence · SUTEL mobile-terminal or free-band homologation · Decree 24037-S ionising-radiation construction, import and operation authorisation
Côte d'Ivoire
6 routes · 10 official sources
AIRP conformity assessment — electromagnetic compatibility · AIRP conformity assessment — protection against electrical hazards · ARTCI homologation of radioelectrical equipment
Croatia
6 routes · 6 official sources
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment · EMC Directive disapplied where MDR fixes the same essential requirements · HAKOM radio-equipment market access (Pravilnik o radijskoj opremi, NN 49/2016)
Cuba
5 routes · 4 official sources
MINCOM homologation or acceptance certificate · MINCOM autorización técnica presented to customs · Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence
Cyprus
7 routes · 16 official sources
Medical electrical equipment outside the Low Voltage Directive · EMC Directive switched off by the more specific MDR essential requirements · Radio Communications (Radio Equipment) Regulations Κ.Δ.Π. 310/2016, as amended
Czech Republic
7 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Nařízení vlády 426/2016 radio equipment conformity
Denmark
7 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Radioudstyrsloven market access
Dominican Republic
4 routes · 4 official sources
Medical electrical safety and EMC evidence inside the sanitary registration · CNE import permit for radioactive sources and ionizing-radiation-emitting devices · CNE institutional operating licence and radiological protection officer licence
Ecuador
3 routes · 3 official sources
ARCSA electrical/EMC evidence · ARCOTEL terminal-equipment homologation · Radiation/legal metrology
Egypt
2 routes · 4 official sources
Medical electrical evidence · NTRA Light/Intermediate/Tight type approval
Estonia
6 routes · 6 official sources
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment · EMC Directive disapplied where MDR fixes the same essential requirements · Radio-equipment essential requirements, conformity assessment and type registration (määrus nr 46)
Ethiopia
5 routes · 4 official sources
ECA type approval of radiocommunications and telecommunications equipment · ECA approval of equipment connected to a telecommunications network · Electrical safety and mechanical/environmental protection evidence in the EFDA dossier
European Union
5 routes · 4 official sources
MDR/IVDR CE conformity · Radio Equipment Directive conformity · RoHS/WEEE/EPR
Finland
7 routes · 9 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Radio equipment requirements under act 917/2014
France
7 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · RED conformity under ANFR market surveillance
Georgia
8 routes · 15 official sources
Radio equipment and telecommunications terminal equipment certification · Radio-frequency spectrum use authorisation · Electromagnetic compatibility essential requirements for radio equipment
Germany
10 routes · 13 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Funkanlagengesetz (RED) conformity
Ghana
1 routes · 1 official source
FDA Ghana essential-principles STED evidence
Greece
8 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Presidential Decree 98/2017 radio equipment market access
Guatemala
2 routes · 5 official sources
Medical electrical safety and EMC evidence inside the sanitary inscription · MEM radiation-practice operating licence and radiological protection officer licence
Hong Kong
5 routes · 7 official sources
Medical electrical evidence · OFCA technical compliance · OFCA voluntary certification/label
Hungary
9 routes · 12 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · 2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties
Iceland
6 routes · 9 official sources
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment · Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device · Fjarskiptastofa radio-equipment market access (reglugerð nr. 944/2019)
India
7 routes · 6 official sources
CDSCO electrical/EMC evidence · WPC ETA · TEC MTCTE
Indonesia
8 routes · 7 official sources
Medical electrical evidence · Komdigi telecommunications-device certification · SNI compulsory certification
Iran
2 routes · 2 official sources
Manufacturing-license test reports and ISO 13485 · Mandatory-standard licence at renewal
Iraq
2 routes · 1 official source
COSQC import inspection and pre-shipment inspection · Radioactive-source authorization
Ireland
7 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · European Union (Radio Equipment) Regulations 2026
Israel
3 routes · 3 official sources
AMAR electrical/EMC evidence · Ministry of Communications wireless import/type approval · SII mandatory standards
Italy
8 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · D.Lgs. 128/2016 radio equipment market access
Japan
6 routes · 5 official sources
PMDA/MHLW electrical/EMC evidence · Radio Law technical conformity/Giteki · Terminal equipment conformity
Jordan
2 routes · 2 official sources
EMRC radiation practice and source licence · TRC type approval (الموافقة النوعية)
Kazakhstan
2 routes · 2 official sources
Registration technical and biological testing · Measuring-instrument state-register entry
Kenya
3 routes · 1 official source
PPB in-country IVD performance testing · KEBS Pre-Verification or Certificate of Conformity · PPE certificate of analysis and ISO 10993-1
Kuwait
5 routes · 6 official sources
Ministry of Health medical device and IVD registration — full dossier · Abridged Review Pathway — approval by a recognised reference authority · Electrical safety and electromagnetic compatibility — dossier item, no separate Kuwaiti certificate
Latvia
6 routes · 7 official sources
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment · EMC Directive disapplied where MDR fixes the same essential requirements · Radio-equipment essential requirements, conformity assessment and market surveillance (Cabinet Regulation No. 215)
Lebanon
5 routes · 11 official sources
TRA type approval for radio and telecommunications terminal equipment · Lebanese Atomic Energy Authority approval to import or export a device · Industrial Research Institute conformity certificate for imported devices
Liechtenstein
7 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Funkanlagen ordinance applying the RED directly under the EEA Agreement
Lithuania
7 routes · 8 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · RRT radio equipment technical regulation
Luxembourg
8 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Loi du 27 juin 2016 on making radio equipment available
Macau
2 routes · 5 official sources
Medical electrical evidence · CTT homologation, import and station licence for radiocommunication equipment
Malaysia
5 routes · 9 official sources
MDA electrical/EMC evidence · MCMC/SIRIM communications product certification · JAKIM medical-device halal certification
Malta
7 routes · 9 official sources
Medical and radiology electrical equipment outside the Low Voltage Regulations · Electromagnetic Compatibility Regulations and the MCCAA as market surveillance authority · Radio Equipment Regulations — MCCAA market surveillance in coordination with the MCA
Mexico
6 routes · 3 official sources
COFEPRIS electrical/EMC evidence · IFT Homologation Type A · IFT Homologation Type B
Moldova
8 routes · 12 official sources
Moldovan market-surveillance and product-conformity framework · Moldovan low-voltage electrical equipment technical regulation · Moldovan electromagnetic-compatibility technical regulation
Mongolia
5 routes · 6 official sources
CRC type approval and conformity mark for information and communication equipment · Legal metrology: type approval, state-database registration and verification of measuring instruments · Licence for radiation generators: possession, use, sale, transport, import and export
Montenegro
8 routes · 17 official sources
Montenegrin electrical-equipment safety requirements · Montenegrin electromagnetic-compatibility requirements · EKIP radio-equipment market access
Morocco
3 routes · 9 official sources
ANRT radio-equipment agrément · ANRT telecommunications terminal equipment agrément · AMSSNuR authorisation for ionizing-radiation installations and sources
Myanmar
1 routes · 2 official sources
Medical electrical evidence
Netherlands
8 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Besluit radioapparaten 2016 conformity
New Zealand
5 routes · 5 official sources
Electricity Act 1992 compliance · Radiation Safety Act 2016 source and use licences · Radiocommunications Act 1989 supplier declaration against the Radio Standards Notice
Nigeria
1 routes · 3 official sources
NAFDAC recognized-standards certificate and lab analysis
North Macedonia
8 routes · 11 official sources
North Macedonian electrical-safety evidence in the device registration dossier · North Macedonian electromagnetic-compatibility evidence in the device registration dossier · AEK radio-equipment opinion for non-harmonised frequency bands
Norway
8 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · EEA radio equipment forskrift market access
Oman
2 routes · 2 official sources
MoH manufacturer registration ISO 13485 · Reference-jurisdiction certificates (CE/510(k)/PMA)
Pakistan
5 routes · 5 official sources
PNRA licence to operate a radiation facility or activity · PNRA No Objection Certificate for import, issued only to licensees · No PNRA control over non-ionizing equipment
Panama
2 routes · 2 official sources
ASEP homologación of telecommunications equipment · IEA reference-laboratory quality-control analysis
Paraguay
6 routes · 7 official sources
DINAVISA device registration dossier — quality and finished-product conformity evidence · CONATEL homologation — equipment that makes use of the radioelectric spectrum · CONATEL homologation — equipment connectable to the public telecommunications network
Peru
4 routes · 4 official sources
DIGEMID electrical/EMC evidence · MTC RF-emitting equipment homologation · MTC public-network equipment homologation
Philippines
7 routes · 3 official sources
FDA electrical/EMC evidence · NTC Type Acceptance · NTC Type Approval
Poland
7 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Radio equipment conformity assessment under Dz.U. 2016 poz. 878
Portugal
7 routes · 10 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Decreto-Lei 57/2017 radio equipment market access
Qatar
2 routes · 3 official sources
MoPH IMD registration evidence · Radiation certificate for facility equipment
Romania
7 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · HG 740/2016 radio equipment market access
Russia
5 routes · 5 official sources
EAEU medical-device safety evidence · EAEU EAC LVD/EMC scope · Radio/high-frequency import authorization
Rwanda
5 routes · 3 official sources
RURA type approval of electronic communications equipment · RURA approval for importation and supply of electronic communications equipment · Radiation protection authorisation or licence, and radiation safety evidence in the device dossier
Saudi Arabia
6 routes · 6 official sources
SFDA electrical/EMC evidence · CST equipment approval/licensing and CoC · SABER Product Certificate of Conformity
Senegal
5 routes · 6 official sources
ARP essential requirements — electromagnetic compatibility · ARP essential requirements — protection against electrical hazards · ARTP prior agrément for radioelectrical equipment
Serbia
3 routes · 4 official sources
Medical electrical evidence · RATEL radio equipment conformity assessment · Electrical/EMC product conformity
Singapore
3 routes · 4 official sources
HSA electrical/EMC evidence · IMDA ESER/SER/GER equipment registration · NEA radiation licence
Slovakia
7 routes · 9 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Nariadenie vlády 193/2016 radio equipment conformity
Slovenia
7 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Pravilnik o radijski opremi
South Africa
5 routes · 4 official sources
SAHPRA electrical/EMC evidence · ICASA Type Approval · NRCS Letter of Authority
South Korea
3 routes · 3 official sources
MFDS electrical/EMC evidence · RRA KC conformity certification/registration/interim certification · Safety Korea product-safety KC
Spain
8 routes · 11 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · RD 188/2016 radio equipment and the CNAF use condition
Sri Lanka
9 routes · 4 official sources
Atomic Energy Regulatory Council licence to use ionizing radiation · Council approval of the facility plan · Council import approval extending to X-ray machines
Sweden
7 routes · 12 official sources
MDR electrical safety in place of the Low Voltage Directive · MDR electromagnetic compatibility in place of the EMC Directive · Radioutrustningslagen market access
Switzerland
4 routes · 3 official sources
Swiss medical electrical/EMC evidence · BAKOM/OFCOM radio market conformity · Swiss or accepted CE conformity marking
Taiwan
4 routes · 2 official sources
TFDA electrical/EMC evidence · NCC Type Approval/DoC/simplified DoC · BSMI inspection/certification
Tanzania
3 routes · 3 official sources
TMDA electrical/EMC evidence · TCRA Type Approval · TBS PVoC Certificate of Conformity
Thailand
8 routes · 5 official sources
Thai FDA electrical/EMC evidence · NBTC SDoC · NBTC Class A
Tunisia
4 routes · 7 official sources
CERT homologation of radio and telecommunications terminal equipment · ANMPS conformity-certificate requirement (CE certificate or ISO 13485) · Import technical control at the ANMPS — Autorisation de Mise à la Consommation
Turkey
4 routes · 5 official sources
Medical-device CE conformity · Radio Equipment Regulation CE conformity · BTK market surveillance
United Arab Emirates
5 routes · 5 official sources
MOHAP electrical/EMC evidence · TDRA equipment registration Level 1/2/3 · MOIAT ECAS
Uganda
2 routes · 2 official sources
UCC type approval of communications equipment · UCC approval at importation or sale of communications equipment
United Kingdom
4 routes · 3 official sources
UK medical-device conformity and MHRA registration · Radio Equipment Regulations conformity · CE/UKCA conformity marking route
Ukraine
1 routes · 2 official sources
TR 753 standards presumption and designated bodies
Uruguay
4 routes · 5 official sources
MERCOSUR essential requirements (Decreto 35/025) · Sterile-product sterilisation documentation · URSEC generic homologation of radio transmitters before sale
United States
7 routes · 4 official sources
FDA recognized electrical/EMC standards evidence · FCC Certification · FCC Supplier's Declaration of Conformity
Uzbekistan
1 routes · 1 official source
Ordinary-route laboratory testing
Vietnam
7 routes · 5 official sources
Medical electrical evidence · MOH medical device import licence · MOST/MIC ICT conformity certification and declaration
Zambia
4 routes · 4 official sources
ZAMRA electrical, radiation and standards evidence in the device dossier · ZICTA equipment type approval · ZCSA compulsory standards
Zimbabwe
4 routes · 7 official sources
MCAZ condom and glove type approval and batch release · POTRAZ equipment type approval · RPAZ authorisation for radiation sources and irradiating devices
Radio module ≠ finished device
A pre-approved module may help, but antenna, enclosure, software, bands, power, and host integration can still change the route.
Measurement needs context
Clinical display, treatment-driving measurement, and trade or billing measurement can fall under different legal-metrology rules.
Radiation has two layers
Product, supplier, and import controls are separate from facility, installation, source-holder, and operator licences.
About this checker
Use the result as a scoping workpaper
The checker evaluates maintained country rules for electrical safety, EMC, radio, telecom, legal metrology, radiation, product-specific conformity, environmental and battery obligations, halal or material-origin rules, and import conformity — each country has its own route list.
It identifies likely routes, missing facts, and official sources. Confirm the final scope before testing, contracting a certification body, importing, installing, or filing.
- Is additional certification the same as medical device classification?
- No. Classification determines the main risk class and medical-device pathway. This tool checks additional certifications, dossier evidence, import documents, and site or operator licences that may apply after or alongside classification.
- Can I compare several countries?
- Yes. Select up to five markets in one free check. The same product facts are evaluated against each country’s maintained scheme matrix.
- Are the results official?
- No. Results are preliminary decision support. Every route includes official starting points so you can verify current scope and confirm the final position with the responsible authority or a qualified expert.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?