Global regulatory
Approval outside India, market by market, planned so that the evidence you already hold is reused wherever a regulator will accept it.
When global regulatory is the right step
When the device is ready for markets beyond India. Plan the markets early, because each one sets its own class, evidence and route.
Choose the markets
Where the device can be approved first, given its class, its evidence and the route in each market.
US 510(k) and EU CE marking
A 510(k) submission to the US FDA, or conformity assessment under the EU MDR for CE marking.
ASEAN, Middle East, Africa and GCC
Registration routes in these markets, each with its own requirements.
What you bring, and what you get back
You bring
- The design history file and the risk file
- Verification, validation and biocompatibility results
- Clinical data or literature, if any
- Labels and instructions for use
- Your target markets, in order of priority
You get back
- A market-by-market regulatory strategy
- The device class in each target market
- A gap list against each market's requirements
- Submission documents: a 510(k), EU technical documentation or a local dossier
- Answers to regulator questions, prepared with you
Approval in one market does not carry to another
Each market classifies the device by its own rules and reviews it under its own law. A device in one class in India can fall in a different class in the EU or the US, with different evidence needed. What travels is the evidence: a design file built to ISO 13485 and ISO 14971 can be reused, with the gaps filled for each market.
How a global regulatory project runs
Questions buyers ask
Does CDSCO approval help in other markets?
It shows a working quality system and evidence behind the device, but other markets do not accept it as their approval. Each reviews the device under its own rules. India, US and EU routes compared.
What is a 510(k)?
A premarket notification to the US FDA under 21 CFR 807. It shows the device is substantially equivalent to a device already legally on the US market. Many Class II devices use it; some devices need a different route.
Does every EU device need a notified body?
No. Under the EU MDR, most Class I devices are self-declared by the manufacturer. Class I devices that are sterile, measure, or are reusable surgical instruments, and all higher classes, involve a notified body.
How do I find my device class?
Start with the class and route tool, then confirm it against each market's rules. It maps the routes.
Regulatory next to design
Regulatory engineers work in the same team as the designers, across nine disciplines, so evidence gaps are closed where the design is made. We have designed and developed 40+ devices.
Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.
Not quite you?
Standards this work is done against
- EU MDR 2017/745European Union
- 21 CFR 807US premarket notification, 510(k)
- ISO 13485Quality management system
The list for a given device, and the edition of each, is set in its regulatory plan.
Where this sits
Also in Co-Commercialize
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