Notified Bodies in India: The Class B 90-Day Audit and Class A Post-Grant Audit

1. Key takeaways

A notified body (NB) in India is a third-party auditing organisation that has been accredited by the national accreditation body and registered with CDSCO; its registration is applied for on Form MD-1 and issued as a registration certificate on Form MD-2 (under Rule 13). Its role is to verify the manufacturing site’s conformity with the quality management system requirements of the Fifth Schedule. For Class B devices, the audit must be completed within 90 days of the application and stands before the licence is granted. For Class A devices, no audit is required before grant, but a post-grant audit must be completed within 120 days of the date of the licence. The notified body therefore sits inside the licensing machinery rather than beside it: its scheduling, its accreditation scope and the validity of its own registration all directly condition whether and when a manufacturing licence can issue. Treating the notified body relationship as a procurement task to be handled after the licence application is the most common structural mistake in Class A/B manufacturing projects, and it is entirely avoidable if the NB is selected and engaged before the application is filed. The sections below set out the legal basis for the NB system, the audit chains for both classes, and the practical steps that keep the audit track from becoming the critical path of the whole project.

2. Legal basis

The table below gathers the provisions on notified body registration, the audit procedure they follow, the Class B audit chain with its stacked time limits, and the Class A post-grant audit obligation.

3. Expert insights

Insight one: India’s notified bodies only handle Class A and Class B. According to the publicly available Indian device legislation materials, the NB’s routine remit covers Class A and Class B medical devices and IVDs only — verifying the conformity of the manufacturing site’s quality management system, verifying the essential requirements, and verifying the validation of manufacturing processes with objective evidence. Inspections of Class C/D sites are carried out by officers of the CLA itself; these are two different forces with two different operating logics, and the project plan should not blur them.

Insight two: the 120 days for Class A is a sword of Damocles held after certification. Many companies assume that once MD-5 is in hand everything is settled. When a major non-conformity is raised at an audit conducted on day 121, the licence is already in hand and the product may already be on sale, and the cost of remediation rises steeply from that moment. The post-grant window rewards companies that finish their quality system readiness before the certificate arrives.

Insight three: notified bodies are a finite resource, and scheduling is the real bottleneck. The 90-day limit for Class B is a limit imposed on the NB, but the body’s actual availability is constrained by its own capacity. In project scheduling, the “NB booking” must be treated as an independent milestone with its own owner and lead time, not as something that “happens naturally after the application is submitted”. Waiting for an audit slot has delayed more Class B projects than any documentation deficiency.

Insight four: the NB’s own registration certificate also requires five-yearly retention. This means that when choosing a notified body, beyond capacity and accreditation scope, the manufacturer should confirm that the NB’s registration is currently valid and that its retention fees are being paid on schedule. A body whose own standing lapses mid-project creates a problem no one budgeted for. Confirmation takes minutes and should be repeated whenever the audit date moves, since validity at booking does not guarantee validity at the audit itself.

4. Practical recommendations

• For local manufacturing projects, complete three things before submitting the MD-3/MD-7: select the notified body and obtain a copy of its MD-2 registration certificate together with its accreditation scope; book the audit window; and run a pre-audit against the Fifth Schedule requirements.
• Treat the pre-audit as the highest return-on-effort action available in an Indian manufacturing project: it converts the surprises that would otherwise surface inside the 90-day statutory window into a corrective action list you control the timing of.
• Match the NB’s accreditation scope against the exact product categories to be manufactured, not just the general device family, before signing the audit contract.
• For Class A projects, hold a standing readiness file for the post-grant audit from the day of application, so the 120-day clock starts against a prepared site.

5. Verification checklist

• □ An NB has been selected and its MD-2 registration certificate verified as currently valid
• □ The NB’s accreditation scope covers the product categories to be manufactured
• □ For Class B, the audit window within 90 days has been booked
• □ For Class A, the post-grant audit within 120 days of the licence has been scheduled
• □ A Fifth Schedule QMS pre-audit has been completed and a corrective action list issued

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