India’s Hidden Compliance: LMPC, AERB, WPC, EPR and BIS

1. Key takeaways

Obtaining an MD-15 does not mean a product can be sold in India. Depending on the product form, additional approvals may be required: LMPC (legal metrology registration for pre-packaged commodities), AERB (Atomic Energy Regulatory Board approval for radiation-emitting equipment), WPC (frequency licensing for devices containing wireless modules), EPR (extended producer responsibility for electronic waste) and BIS (standards certification for categories subject to mandatory certification).

• Clearance is not market access: the device licence covers the product, not the other regulatory regimes that attach to its form.
• Four additional regimes plus standards: metrology, atomic energy, wireless and e-waste obligations sit outside the MDR 2017.
• The single window is a policy direction, not yet an operating reality: the 2023 policy commits to integration with AERB, MeitY and DAHD.
• BIS is the most expansionary of these regimes: Rule 7 already gives BIS standards priority, and the policy reinforces that role.

2. Legal basis

The table below separates the points that rest on published instruments from the points that rest on industry compilation. The latter are marked as a third-level source and require item-by-item verification of applicability before being relied on in a project plan.

3. Expert insights

Insight 1: India is a market of parallel ministries. The health ministry regulates devices, the metrology department regulates pre-packaged goods, the communications department regulates wireless modules, the environment ministry regulates electronic waste, and the Atomic Energy Regulatory Board regulates radiation. An imaging device with a wireless module can fall under four departments at once. No single filing resolves all four, and each has its own documentation and its own review rhythm. The coordination burden falls on the manufacturer, because none of these departments answers to the others.

Insight 2: policy is moving towards a single window, but has not arrived. The National Medical Devices Policy, 2023 wrote the establishment of a single-window clearance system incorporating AERB, MeitY and DAHD into its regulatory simplification strategy. The direction is clear; implementation will take time. Until it is operational, each approval has to be pursued through its own channel and its own timeline. The practical estimate is that the single window will simplify coordination, not eliminate the substantive requirements of each department.

Insight 3: BIS is the most expansionary of the additional regimes. Rule 7 already places BIS standards first, and the policy explicitly reinforces the BIS role. This means the list of categories under mandatory BIS certification may grow, and companies should treat it as a long-term variable rather than a fixed current list. A product outside the list today may not stay outside it for the life of the licence. Product planning should therefore leave room for a certification step that is not required at launch but may become required during the licence cycle.

Insight 4: these costs are not in the Second Schedule of the MDR 2017. They are fees and timelines under separate instruments. When building an India budget, the Second Schedule is only one block of the total, and the additional regimes carry their own charges and their own waiting periods that run alongside — not inside — the device licensing process. A budget built only from the Second Schedule will understate both the money and the time required to reach the market.

4. Practical recommendations

• Run an additional-compliance applicability screening at project kick-off. At the start of an India project, GRZAN prepares an additional-compliance applicability screening that assesses, item by item and by product form, whether LMPC applies (is the product sold in pre-packaged retail form), AERB (does it emit ionising radiation), WPC (does it contain a wireless module), EPR (is it an electrical or electronic product) and BIS (is the category within the mandatory certification list).
• Complete the screening before quoting. It affects both the cost line and the timeline, and these timelines are not bound by the CDSCO’s 9-month review period.
• Schedule the additional approvals in parallel with the device filing. Running them sequentially lengthens the project by the sum of all the waiting periods. Parallel scheduling does not shorten any individual process, but it prevents the additional approvals from becoming the critical path after the device licence is already in hand.
• Re-check the BIS list at each product change. Because the mandatory certification list can expand, a category check performed at launch should be repeated when a new model or variant is added.
• Record which points rest on third-level sources. Where applicability rests on industry compilation rather than a published instrument, confirm the position before committing to a plan.

5. Verification checklist

• □ Whether the product is sold in pre-packaged retail form has been assessed (LMPC)
• □ Whether the product emits ionising radiation has been assessed (AERB)
• □ Whether the product contains a wireless module has been assessed (WPC)
• □ Whether the product is an electrical or electronic product has been assessed (EPR)
• □ Whether the category is within the mandatory BIS certification list has been checked
• □ The timelines for additional compliance have been scheduled separately into the project plan

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