Since the Medical Device Rules, 2017 (and the staged notifications that followed), essentially all medical devices in India — thermometers to stents, glucometers to software — are regulated as drugs with their own licensing grid. Whether you manufacture, import or merely trade devices, there is a form with your name on it. The system looks intimidating; it is actually a risk-class lookup followed by a defined pathway. Here is the starter map.
Step 1: Classify — everything follows from risk class
- Class A (low risk): thermometers, tongue depressors, absorbent cotton
- Class B (low-moderate): hypodermic needles, BP monitors, many diagnostics
- Class C (moderate-high): ventilators, bone fixation, dialysis equipment
- Class D (high): stents, heart valves, implants sustaining life
- CDSCO's published classification lists map most device types; software-as-device and IVDs (in-vitro diagnostics) classify under their own parallel grids
Class decides your licensing authority (state for A/B manufacturing, central for C/D), your form numbers, and your evidence burden.
Step 2: Pick your pathway
Manufacturing in India: Class A/B → application MD-3 for licence MD-5 from the State Licensing Authority (Class A non-sterile/non-measuring now largely self-registers); Class C/D → MD-7 for licence MD-9 from CDSCO central. Loan-licence analogues (MD-6/MD-10) cover brand owners using others' facilities. Importing: registration via authorised Indian agent — MD-14 application for MD-15 import licence, riding on the foreign manufacturer's credentials (free-sale certificates, QMS, technical dossiers). Trading/distribution: wholesale/retail of devices runs on the drugs-style sale licences per state practice, and marketplaces ask for exactly these.
The QMS backbone
- Licences presume a quality management system per the Fifth Schedule (aligned to ISO 13485 thinking) — design controls, purchase controls, production records, complaint handling, recalls
- Manufacturing sites face audits (notified bodies audit Class A/B; CDSCO inspects C/D)
- Technical staff requirements apply per class and activity
- Post-market: adverse-event reporting through the materiovigilance programme, field-safety corrective action procedures, and licence retention through periodic fees
Class A self-registration: days. Class B MD-5: roughly 3–6 months including notified-body audit. Class C/D MD-9: 6–12 months with dossier depth. Imports (MD-15): 4–9 months riding on manufacturer documentation quality. Fundraising and launch decks should carry these numbers, not hopes.
Labels, UDI and the selling stack
Device labels carry MDR-prescribed particulars (licence numbers, manufacturer/importer, lot/serial, expiry where applicable, storage conditions) with UDI (unique device identification) obligations phasing across classes. Selling adds the familiar Indian stack: GST, Legal Metrology for measuring devices' packaging, BIS where a device type also carries a standards mandate, and e-marketplace dossier checks. Hospital and government tenders will ask for the licence, QMS certificates and often WHO-GMP/CE credentials — assemble the binder once, win repeatedly.
Common founder scenarios, mapped
'We import pulse oximeters from China': appoint yourself authorised agent, obtain MD-15 with the manufacturer's dossier — and verify their plant certificates early; weak foreign paperwork is the usual delay. 'We assemble diagnostic kits': assembly is manufacturing — classify the IVD, expect MD-5/MD-9 with QMS. 'Our app analyses ECGs': software with a medical purpose classifies as a device — plan classification advice before the app store listing. 'We only distribute to hospitals': wholesale licence per your state's device-sale regime, plus your principals' licences on file.
How Aidwish helps
Aidwish navigates device regulation for manufacturers and importers — classification opinions, licence applications (MD-3/5/7/9/14/15), QMS documentation builds, notified-body coordination and the tender-ready binder — turning MDR 2017 from a barrier into a moat.