Medical Devices
Medical Device Regulatory Compliance and Market Access
Sanitary registrations, electrical safety, EMC, radio approval, and local representation for medical equipment, connected devices, diagnostics, monitoring, and medical electronics across global markets.
The sector
Medical devices are approved by health authorities, and by everyone else too.
A medical device entering a new market answers to the national health authority first: classification, registration or licensing, quality system evidence, clinical or performance data, labeling, and a local registration holder who takes legal responsibility for the product in that country. That process alone is demanding, differs widely between markets, and is where medical device manufacturers focus their regulatory effort.
But a modern medical device is also an electrical product, often a radio product, usually a battery product, and always a product with substance and producer obligations. The electrical safety and EMC evidence under IEC 60601 feeds the health authority file and, in many markets, separate electrical certification. The Wi-Fi and Bluetooth in a connected monitor need radio type approval from the communications regulator, who doesn't care that the device is medical. The battery needs its own certification and registration. The label needs to satisfy all of them at once.
ORBIS Compliance works with medical device manufacturers across that whole picture: sanitary registration and local holder representation, electrical safety and EMC, radio approval, battery and substance compliance, and the environmental obligations that follow the device into each market. One accountable Legal & Engineering Global Regulatory Advisory, with the medical file and the electronics file as one product record.
Device categories
Medical device categories we support
- Medical Equipment
Capital equipment, therapy devices, and clinical systems under IEC 60601, health authority registration, and electrical certification.
- Connected Medical Devices
Devices with wireless connectivity, apps, and cloud services, where medical, radio, and cybersecurity regulation converge.
- Diagnostics
In vitro diagnostic instruments, reagents, and self-tests under IVD-specific rules that many markets have recently tightened.
- Monitoring
Patient monitors, wearables, and remote monitoring systems, from hospital to home, with the classification and radio questions they raise.
- Medical Electronics
Power supplies, modules, and electronic sub-assemblies for medical devices, certified so the devices built on them can be approved faster.
How medical market access usually runs
The health file and the electronics file, separate or together.
Handled by separate specialists
What matters
One product record with ORBIS
A regulatory consultant handles the sanitary registration and knows nothing about the radio.
REGISTRATION
Sanitary registration, radio approval, and electrical certification scoped as one program per market.
The distributor holds the registration, and the market access goes with the relationship.
LOCAL HOLDER
Independent local holder representation keeps registrations under your control.
IEC 60601 reports are generated for the health authority and again for electrical certification.
EVIDENCE
One test program designed to serve both, with reports reused across markets that accept them.
A firmware or component change is assessed for the health authority and missed for the radio grant.
CHANGE
Changes assessed against every affected approval in ORBIS Intelligent Compliance.
How ORBIS is involved
Regulatory professionals for the health authority, engineers for the device, one record for both.
ORBIS manages sanitary registrations with national health authorities, including classification, dossier preparation to each authority's format, reliance on reference-country approvals where available, and the local registration holder most markets require. Our regulatory professionals engage health authorities directly when classification or requirements are unclear for a novel device.
Our engineers scope the electrical safety and EMC evidence under IEC 60601 and its collateral and particular standards, the radio approvals for connected devices, and the battery, substance, and environmental obligations, so the whole file describes one device and every market's requirements are met from shared evidence.
Every registration, certificate, and obligation lives in ORBIS Intelligent Compliance with its holder, validity, and change triggers. When a component changes or a regulation moves, your team sees which approvals are affected and what to do.
Questions
Medical device compliance
We have FDA clearance and a CE mark. What do other markets require?
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Most markets outside the US and EU require their own registration with the national health authority, often with a local registration holder. Many offer reliance or abbreviated routes for devices with FDA, CE, Health Canada, or PMDA approval, which shortens the review but doesn't remove the registration. ORBIS maps the route for your device in each market.
Does the communications regulator care that our device is medical?
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No. Radio type approval is required for any transmitter regardless of its application, from the communications authority, under its own process. Medical device registration doesn't substitute for it, and it's a frequent gap in connected medical device programs.
Who should hold our medical device registrations in each country?
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An independent local holder, rather than your distributor, keeps the registration under your control and separates market access from commercial relationships. Transferring a registration held by a departing distributor is slow where possible and impossible in some markets. ORBIS provides local holder representation for exactly this reason.
Get the device to the patients who need it, in every market.
Bring the device, its classification and reference-country approvals, and the countries on your plan. We'll map the registrations, the electrical and radio approvals, and the local holders each market requires.
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