India Manufacturing Licences: SLA and CLA Routes under MD-5 and MD-9

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Manufacturing licences in India are received according to risk class, and the receiving authority differs by that class. Class A/B applications go to the State Licensing Authority (SLA), using application MD-3 with licence issued as MD-5 (and for loan licence manufacturing, application MD-4 with licence MD-6); Class A is exempt from a pre-grant audit and must be licensed within 45 days, while Class B must first pass a notified body audit before grant. Class C/D applications go to the Central Licensing Authority (CLA), using application MD-7 with licence issued as MD-9 (and for loan licences, MD-8 with MD-10), following a sequence of 45 days of documentary scrutiny, plus a 60-day window for the site inspection, plus a decision within 45 days after the inspection report is received. The practical consequence is that the same group with the same product can face completely different authorities, document chains, audit regimes and fee currencies depending only on which side of the class boundary its portfolio falls, so the class determination must be settled before any manufacturing project plan is drawn up.

2. Legal basis

The table below assembles the provisions for both authorities, the audit chains that precede or follow grant, and the manufacturing fee entries that apply at each class.

Class A/B authority	MDR 2017 Rule 20(1)(2)(4)	Apply to the SLA on MD-3 (own manufacture) or MD-4 (loan licence); licences issued as MD-5 or MD-6; the SLA must grant or reject in writing within 45 days from the date of the application
Class A exemption from pre-grant audit	MDR 2017 Rule 20(4) proviso (i)(ii)	No audit is required before grant; however, a registered notified body must complete the site audit within 120 days from the date of the licence
Class B audit chain	MDR 2017 Rule 20(6)	The notified body must complete the audit within 90 days of the application, submit its report within 30 days of completion, and the SLA decides within 20 days of receiving the report
Class C/D authority	MDR 2017 Rule 21(1)(4); Nishith Desai analysis	Apply to the CLA on MD-7/MD-8; documentary scrutiny 45 days (Rule 21(4))
Class C/D inspection	MDR 2017 Rule 23(1)	The site inspection must be completed within 60 days of the application
Class C/D decision	MDR 2017 Rule 25(1)	The CLA must decide within 45 days of receiving the inspection report; licences issued as MD-9 or MD-10
Class B manufacturing fee	MDR 2017 Second Schedule	Site fee INR 5,000 plus INR 500 per device
Class C/D manufacturing fee	Same source	Site fee INR 50,000 plus INR 1,000 per device

3. Expert insights

Insight one: Class A operates on a licence-first, audit-later design. This is one of the rare reverse sequences in the Indian framework. After the company receives MD-5, it still has 120 days to prepare for and undergo the notified body audit. That window is not a grace period; it is a performance period. Missing the audit window or failing the audit directly affects whether the licence survives, which means production should not scale ahead of quality readiness simply because the certificate has arrived.

Insight two: the 140 days for Class B is four time limits stacked together. Ninety days for the audit, plus thirty days for the report, plus twenty days for the decision, equals 140 days, which matches the officially published figure for the Class B manufacturing licence timeline. The 105 days for Class C/D similarly decomposes into the 45-day scrutiny and 60-day inspection running, with the final 45-day decision taken after the report arrives.

Insight three: manufacturing fees and import fees are two separate systems. Manufacturing is priced in rupees (the Class C/D site fee is INR 50,000), while importing is priced in US dollars (the Class C/D site fee is USD 3,000). The official cost structure of setting up a factory in India versus importing directly is therefore built on different currencies and different line items, and comparing them requires converting both into the same frame before any conclusion is drawn.

Insight four: a 2026 draft is compressing these timelines. The draft notification G.S.R. 515(E) proposes reducing the Class B timeline from 140 days to 115 days and the Class C/D timeline from 105 days to 90 days. The draft has not yet entered into force, and the current timelines continue to apply, so planning should proceed on the present figures while tracking the amendment.

4. Practical recommendations

For customers considering a factory in India, build a side-by-side comparison of importing versus local manufacturing covering: official fees (dollars versus rupees), timelines (nine months versus 45/140/105 days), audit requirements (overseas site inspection versus notified body audit) and post-market obligations (where vigilance responsibility lands).
Read the comparison honestly: many customers assume local manufacturing is always cheaper, and the table usually shows that for Class A/B local manufacturing is indeed faster and cheaper, while for Class C/D the factory investment must be counted in before the answer is clear.
Schedule the Class A post-grant audit immediately after licence receipt, treating the 120-day window as a delivery deadline for quality system readiness, not as spare time.
Book the Class B notified body audit as early as possible in the application window, since the 90-day limit binds the audit itself and the whole chain follows from it.
Track the G.S.R. 515(E) draft separately from the current rules, and keep two versions of the project schedule until the amendment status is resolved.

5. Verification checklist

□ The correct authority, SLA or CLA, has been determined by risk class
□ For Class A, the notified body audit within 120 days of the licence has been scheduled
□ For Class B, the site audit within 90 days has been booked with the notified body
□ For Class C/D, the schedule follows the 45 + 60 + 45 day structure
□ Fees have been calculated under the manufacturing line items (rupees), not the import line items (dollars)
□ The G.S.R. 515(E) draft is being tracked (draft, not in force)

Regulatory information verified as of October 27, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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