India’s US$6,000 Overseas Manufacturing Site Inspection Fee

1. Key takeaways

India’s Central Licensing Authority may, under Rule 34(1) of the Medical Devices Rules, 2017, inspect an overseas manufacturing site itself or through a person it authorises. The resulting fee is US$6,000 under the Second Schedule, borne by the applicant. CDSCO states explicitly that an overseas manufacturing site inspection may take place before or after the grant of the licence, as the case requires — so holding an MD-15 does not remove the inspection risk.

• Statutory power: Rule 34(1) allows the CLA to inspect an overseas site directly or through an authorised person or body.
• Cost to the applicant: the US$6,000 inspection fee under the Second Schedule is payable by the applicant, not by the authority.
• Timing is open-ended: inspection may occur before or after the licence is issued.
• The 9-month clock is unaffected: Rule 36(1) requires a decision within 9 months of application whether or not an inspection takes place.

2. Legal basis

The inspection power, its cost and its timing are set out across Rule 34(1), the Second Schedule and Rule 36(1). The table consolidates the operative text points.

3. Expert insights

Insight 1: the US$6,000 is a contingent cost, not an application fee. It is not payable at submission; it arises when CDSCO decides to inspect. In a budget it therefore belongs on a separate line and must not be merged into fixed costs. Treating it as fixed either overstates the minimum cost of entry or, worse, leads a company to assume the money has bought an inspection that will never be scheduled. The cleanest convention is a two-column budget: committed fees on one side, triggered fees on the other, with the inspection row explicitly marked as pending verification of whether CDSCO will call for a visit.

Insight 2: the 9-month review period is unaffected by inspection. Rule 36(1) is worded so that the 9-month clock runs whether or not a site inspection is conducted. This means an inspection does not buy the company extra preparation time: the decision deadline stays where it was, and a site that is not inspection-ready at short notice is exposed rather than protected. Planning therefore has to assume that the visit may arrive at any point in the review window, with limited notice and no extension of the overall timeline.

Insight 3: inspection can follow the grant of the licence. This is the point most often overlooked. A company that relaxes site management once the MD-15 is in hand, and is inspected in month 13, faces the same problems as one inspected before approval — except that the licence is now in force and the consequences land on a live product. Post-market standing depends on the site remaining in the condition described in the file. In practice the most common gap is not a dramatic change but a gradual one: a line relocated within the building, a warehouse extended, a contract manufacturer added, none of which was reflected in the plant master file.

Insight 4: the PMF is the first document the inspection team reads. The plant master file prepared under Appendix I of the Fourth Schedule sets the expectations that the inspection team carries into the visit. A mismatch between the PMF and the actual site is a direct source of non-conformities, and it is the kind of mismatch that arises from routine changes — a new line, a moved warehouse, a changed supplier — that nobody thought to reflect in the file. Because the file is written once and the site changes continuously, the PMF drifts unless someone owns it.

4. Practical recommendations

• Treat overseas inspection as a whole-lifecycle matter, not an application-stage task. GRZAN treats the overseas site inspection as a full-cycle issue rather than a filing step, and requires clients to maintain site conditions after the MD-15 is granted and to keep operating in line with the PMF description.
• Prepare an inspection-response plan as a standing document. We recommend that clients keep a standing inspection-response file: a named contact person, a bilingual index of system documents, and accompanying staff who understand both the technology and English.
• Keep the PMF synchronised with the actual site. Any change to buildings, lines, utilities or key suppliers should trigger a PMF review rather than being recorded only in internal quality documents.
• Budget the US$6,000 as a separate contingent line. Do not fold it into the fixed registration fee, because it is triggered by a decision rather than by filing.
• Rehearse the walk-through before any inspection is announced. The value of a prepared plan when an inspection actually arrives is far higher than that of an ad hoc organisation assembled at short notice.

5. Verification checklist

• □ The US$6,000 is listed separately as a contingent cost
• □ The PMF is consistent with the actual site conditions
• □ An inspection contact person and accompanying staff have been designated
• □ An English index of system documents is available
• □ Site conditions are maintained after the licence is granted (inspection may follow issuance)

Regulatory information verified as of 27 October 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