India Standards Hierarchy: BIS, ISO and IEC

1. Key takeaways

India applies a defined order to device standards. Rule 7 of the Medical Devices Rules, 2017 provides that a device must conform to the standards established by the Bureau of Indian Standards (BIS). Where no BIS standard has been established for that device, it must conform to standards established by the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC), or to any other pharmacopoeial standard. Where neither BIS nor ISO/IEC has a standard, it must conform to the validated manufacturer standard.

• The three tiers are a hierarchy, not a menu: each tier applies only when the tier above has no applicable standard.
• Applicants who go straight to ISO standards can skip a tier where a BIS standard already exists.
• The validated manufacturer standard is a legitimate route for innovative products, provided validation is demonstrated.
• The standards list must be mapped into the essential principles conformity checklist under Rule 6.
• The National Medical Devices Policy, 2023 signals a strengthened role for BIS standards over time.

2. Legal basis

The hierarchy is set by Rule 7, and it operates alongside the essential principles requirements of Rule 6 and the policy direction set out in the National Medical Devices Policy, 2023. The table below sets out each element.

3. Expert insights

Insight one: this is a ladder, not a free choice. Enterprises often declare against ISO standards directly, and in categories where a BIS standard exists that step simply misses a rung. The correct approach is to first check whether a current BIS standard exists for the category, and if it does, to follow BIS. Checking this at the start of a project is inexpensive; discovering it during review means reworking the standards column of the entire essential principles checklist. Because the checklist is cross-referenced throughout the technical file, a late correction propagates into many other sections at once.

Insight two: the validated manufacturer standard is the last tier, and it is also an opportunity. For innovative products where neither BIS nor ISO has a standard, the enterprise’s own standard may be applied once validated. This is a lawful route for new products entering India, but “validated” is the operative word — a self-declared manufacturer standard that has not been validated is not accepted. The validation evidence should be assembled as a distinct document rather than asserted inside the technical file.

Insight three: the role of BIS is still growing. The National Medical Devices Policy, 2023 writes “strengthening the role of Indian standards such as BIS” into its regulatory simplification strategy. This means the coverage of BIS standards is likely to expand, and the first rung of the ladder will be used more and more often. Companies building a multi-year India portfolio should track BIS publications for their categories rather than treating the current standard set as fixed. A standard that does not exist today may exist by the next registration cycle, at which point the earlier ISO-based declaration becomes a compliance question rather than a technical preference.

Insight four: the standards list must be written into the essential principles conformity checklist. The essential principles under Rule 6 and the standards under Rule 7 correspond to each other. Each entry in the essential principles checklist must state the standard on which it relies, and if the standard is chosen wrongly, the entire checklist fails to stand. The checklist is therefore not a formatting exercise; it is the point at which the standards hierarchy becomes visible to the reviewer.

4. Practical recommendations

When preparing technical documentation, GRZAN first produces a standards applicability determination table: every standard applicable to the product is listed, marked according to which tier it belongs to — BIS, ISO, IEC, pharmacopoeial, or manufacturer — and accompanied by a statement of why no applicable standard exists at the tier above. This table serves two purposes: it is used to complete the essential principles checklist, and it is a ready-made answer to questions of the form “why was no BIS standard applied”. It also gives the client a single place to update when a standard changes.

• Search for a current BIS standard in the product category before selecting any other standard.
• Record the tier of every standard selected, so that the hierarchy is visible on the face of the table.
• Prepare validation evidence as a standalone document where a manufacturer standard is relied upon.
• Map the standards table directly into the essential principles conformity checklist.
• Include a written justification for each case where a higher tier was not applicable.
• Review the standards table whenever a new BIS standard is published for the category.

5. Verification checklist

• □ A search has been carried out for a current BIS standard in this product category
• □ Where no BIS standard exists, the applicable ISO/IEC or pharmacopoeial standard has been identified
• □ Where neither exists, a validated manufacturer standard has been prepared
• □ The standards list has been mapped to the essential principles conformity checklist
• □ The reasons for not applying a higher-tier standard have been stated

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