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.
40 markets196 maintained routes87 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 · 2 official sources
Medical electrical and EMC evidence · AKEP radio equipment conformity notification/recognition · Radiation and legal-metrology authorization
Argentina
4 routes · 2 official sources
ANMAT electrical/EMC evidence · ENACOM homologation · RAMATEL
Australia
4 routes · 3 official sources
TGA electrical/EMC evidence · EESS · ACMA RCM
Bangladesh
4 routes · 1 official source
Medical electrical evidence · BTRC radio equipment approval/enlistment · BSTI electrical/component conformity
Belarus
5 routes · 2 official sources
EAEU medical-device safety evidence · EAEU EAC LVD/EMC scope · Radio/high-frequency import authorization
Brazil
5 routes · 5 official sources
INMETRO/SBAC conformity certificate · ANATEL certification and homologation · INMETRO legal-metrology type approval/verification
Canada
4 routes · 3 official sources
Health Canada electrical/EMC evidence · ISED equipment certification/registration · Radiation Emitting Devices Act compliance
China
6 routes · 3 official sources
NMPA electrical/EMC evidence · SRRC radio transmission equipment type approval · CCC
Colombia
4 routes · 1 official source
INVIMA electrical/EMC evidence · CRC terminal-equipment homologation · RETIE/component scope
Costa Rica
3 routes · 1 official source
Medical electrical evidence · SUTEL mobile-terminal or free-band homologation · Radiation/legal metrology
Ecuador
4 routes · 1 official source
ARCSA electrical/EMC evidence · ARCOTEL terminal-equipment homologation · INEN electrical product scope
Egypt
4 routes · 2 official sources
Medical electrical evidence · NTRA Light/Intermediate/Tight type approval · Electrical/import conformity
European Union
5 routes · 3 official sources
MDR/IVDR CE conformity · Radio Equipment Directive conformity · RoHS/WEEE/EPR
Hong Kong
5 routes · 2 official sources
Medical electrical evidence · OFCA technical compliance · OFCA voluntary certification/label
India
7 routes · 4 official sources
CDSCO electrical/EMC evidence · WPC ETA · TEC MTCTE
Indonesia
7 routes · 3 official sources
Medical electrical evidence · Komdigi telecommunications-device certification · SNI compulsory certification
Israel
4 routes · 2 official sources
AMAR electrical/EMC evidence · Ministry of Communications wireless import/type approval · SII mandatory standards
Japan
6 routes · 3 official sources
PMDA/MHLW electrical/EMC evidence · Radio Law technical conformity/Giteki · Terminal equipment conformity
Macau
4 routes · 2 official sources
Medical electrical evidence · CTT homologation/import/use · Mobile-terminal exemption
Malaysia
5 routes · 2 official sources
MDA electrical/EMC evidence · MCMC/SIRIM communications product certification · Energy Commission electrical conformity
Mexico
7 routes · 3 official sources
COFEPRIS electrical/EMC evidence · IFT Homologation Type A · IFT Homologation Type B
Myanmar
3 routes · 1 official source
Medical electrical evidence · PTD telecommunications equipment technical approval/import permission · Radiation/legal metrology
Pakistan
4 routes · 1 official source
DRAP electrical/EMC evidence · PTA terminal-equipment Type Approval Certificate · PSQCA compulsory product conformity
Peru
5 routes · 2 official sources
DIGEMID electrical/EMC evidence · MTC RF-emitting equipment homologation · MTC public-network equipment homologation
Philippines
6 routes · 2 official sources
FDA electrical/EMC evidence · NTC Type Acceptance · NTC Type Approval
Russia
6 routes · 2 official sources
EAEU medical-device safety evidence · EAEU EAC LVD/EMC scope · Radio/high-frequency import authorization
Saudi Arabia
6 routes · 3 official sources
SFDA electrical/EMC evidence · CST equipment approval/licensing and CoC · SABER Product Certificate of Conformity
Serbia
4 routes · 2 official sources
Medical electrical evidence · RATEL radio equipment conformity assessment · Electrical/EMC product conformity
Singapore
4 routes · 2 official sources
HSA electrical/EMC evidence · IMDA ESER/SER/GER equipment registration · Consumer Protection controlled-goods scope
South Africa
5 routes · 2 official sources
SAHPRA electrical/EMC evidence · ICASA Type Approval · NRCS Letter of Authority
South Korea
4 routes · 2 official sources
MFDS electrical/EMC evidence · RRA KC conformity certification/registration/interim certification · Safety Korea product-safety KC
Switzerland
4 routes · 2 official sources
Swiss medical electrical/EMC evidence · BAKOM/OFCOM radio market conformity · Swiss or accepted CE conformity marking
Taiwan
5 routes · 1 official source
TFDA electrical/EMC evidence · NCC Type Approval/DoC/simplified DoC · BSMI inspection/certification
Tanzania
5 routes · 3 official sources
TMDA electrical/EMC evidence · TCRA Type Approval · TBS PVoC Certificate of Conformity
Thailand
7 routes · 1 official source
Thai FDA electrical/EMC evidence · NBTC SDoC · NBTC Class A
Turkey
5 routes · 2 official sources
Medical-device CE conformity · Radio Equipment Regulation CE conformity · BTK market surveillance
United Arab Emirates
5 routes · 2 official sources
MOHAP electrical/EMC evidence · TDRA equipment registration Level 1/2/3 · MOIAT ECAS
United Kingdom
5 routes · 2 official sources
UK medical-device conformity and MHRA registration · Radio Equipment Regulations conformity · CE/UKCA conformity marking route
United States
7 routes · 4 official sources
FDA recognized electrical/EMC standards evidence · FCC Certification · FCC Supplier's Declaration of Conformity
Vietnam
6 routes · 1 official source
Medical electrical evidence · MIC type approval/certification and declaration of conformity · CR marking
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?