FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
- Product category and formulation assessment
- Claims and substantiation matrix
- Licence application dossier
Regulatory pathways
Which route does your product actually take?
The pathway depends on intended use, claims, risk class and the market you are entering — not on the technology alone. These pages set out what each route requires, so you can tell which one applies before you commission evidence against the wrong one.
India
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
- Formulation basis assessment
- Schedule T GMP gap assessment
- Licence application dossier
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
- Classification rationale
- Regulatory gap assessment
- Test and clinical evidence plan
Cosmetics — India
Do I need an import registration or a manufacturing licence — and who issues it?
- Route determination — registration or manufacturing licence
- Form COS-1 registration dossier
- Labelling compliance review
NDCT 2019 — clinical trials
What approvals does a clinical trial in India need, and in what order?
- Application route assessment
- CDSCO submission dossier
- Ethics committee submission package
BIS certification
Does my product need a BIS licence, and against which Indian Standard?
- Scheme applicability assessment
- Applicable standards matrix
- Testing plan and laboratory coordination
United States
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
- Predicate matrix and rationale
- Substantial equivalence comparison
- Testing matrix
De Novo — US FDA
There is no predicate for my device. What route is left?
- Pathway assessment
- Risk and benefit characterisation
- Proposed special controls
PMA — US FDA
My device is high risk. What does a PMA actually demand?
- Feasibility and route assessment
- Safety and effectiveness evidence plan
- Clinical strategy
European Union
EU MDR 2017/745
What does EU MDR require beyond what I already have?
- MDR gap assessment
- Classification
- Clinical evidence and CER plan
International standards
Applicable standards
Standards selected per device, not per route
These are not separate pathways. Which of them apply is determined by the device itself — its materials, whether it carries electronics or software, and how it contacts the patient — and they feed the verification and validation plan.
ASTM International
Device-specific material, mechanical and performance test standards, selected per device and linked to verification and validation.
Output: Standards applicability matrix, test-method rationale and traceability
ISO 14155
Good clinical practice for clinical investigations of medical devices in human subjects.
Output: Clinical investigation plan aligned to the standard
IEC standards
Electrical safety, electromagnetic compatibility, software lifecycle and usability engineering, where the device involves them.
Output: Applicable standards matrix and evidence plan
*Applicability is product-specific. Classification, applicable standards, testing, clinical evidence and submission route must be confirmed for the specific device, intended use, claims, risk profile and target market under current requirements.
Confirm the pathway before you spend on evidence
A Readiness Assessment establishes classification, the applicable route and the evidence you will need — which is considerably cheaper than discovering it after testing.