E-Waste (Management) Rules, 2022
If you import or brand electronic medical equipment, you are a producer
The E-Waste (Management) Rules, 2022 came into force on 1 April 2023 and brought medical devices squarely into India’s extended producer responsibility regime. The definition of producer in Rule 3(1)(t) captures anyone who sells under their own brand, and anyone who offers to sell imported electrical and electronic equipment. An Indian importer of CT scanners or analysers is a producer, with the obligations that follow.
Medfins International determines whether your portfolio falls within Schedule I, registers you on the CPCB portal, calculates your targets correctly, and keeps the quarterly and annual filings on time.
Medical devices in Schedule I
Category (vi) of Schedule I is headed Medical Devices, with the exception of all implanted and infected products, and runs from MDW1 to MDW10:
- MDW1 Radiotherapy equipment and accessories
- MDW2 Cardiology equipment and accessories
- MDW3 Dialysis equipment and accessories
- MDW4 Pulmonary ventilators and accessories
- MDW5 Nuclear medicine equipment and accessories
- MDW6 Laboratory equipment for in vitro diagnosis and accessories
- MDW7 Analysers and accessories
- MDW8 MRI, PET, CT and ultrasound equipment with accessories
- MDW9 Fertilization tests equipment and accessories
- MDW10 Other electrical appliances, equipment and kits used for preventing, screening, detecting, monitoring, evaluating, examining, investigating, treating illness, disease, injury or disability, and their accessories
Category (vii) adds laboratory instruments as LIW1 and LIW2. An IVD business frequently sits in both MDW6 or MDW7 and LIW.
How the target is actually calculated
This is the part that is most often got wrong. The recycling target for a given year applies to the quantity of equipment you placed on the market in year Y minus X, where X is the average life of that product as published by CPCB. Average lives differ sharply across the medical codes, from seven years for some MDW10 items to twenty years for radiotherapy and nuclear medicine equipment.
The target percentages under Schedule III are 60% for 2023-24 and 2024-25, 70% for 2025-26 and 2026-27, and 80% from 2027-28 onwards. A producer whose years of operation are shorter than the average life of its products uses Schedule IV instead.
In practice this means a company registering today may be answering for equipment it sold a decade or more ago, and will need a chartered accountant certificate of quantities placed on the market, financial year by financial year, by weight in metric tonnes.
Meeting the obligation
Responsibility lies entirely on the producer, even where collection is outsourced. The obligation is discharged by purchasing EPR certificates online from registered recyclers only, and Rule 15(2) requires that this be done proportionately on a quarterly basis rather than in a single annual purchase. Certificates are valid for two years from the end of the financial year in which they were generated.
RoHS now bites
The restriction of hazardous substances provisions apply to medical devices placed on the market after 1 April 2025, subject to the exemptions in Schedule II A, which cover items such as lead in X-ray tubes and shielding, lead in alloys used as superconductor or thermal conductor in MRI, and cadmium in X-ray measurement filters. Compliance is by self-declaration, supported by technical documentation that CPCB may call for, and CPCB conducts random market sampling at the producer’s cost.
Where this goes wrong
- Reading the implanted and infected exclusion too widely. It is an exception within the category heading, not a general exemption for medical devices.
- Applying one average life to the whole portfolio. CPCB publishes different average lives by item. Using a single figure produces a target that is wrong in both directions.
- Buying certificates annually. The rules require proportionate quarterly purchase. Catching up in March is a breach even if the annual total is met.
- Registering for too few EEE codes. Adding codes later is a chargeable amendment, and selling an unregistered code in the meantime is not covered.
- Missing the 1 April 2025 RoHS line. Many medical portfolios were built on the assumption that RoHS did not apply to them in India. For equipment placed on the market after that date, it does.
- Assuming an importer always needs its own registration. CPCB has clarified that an importer selling only to an already registered producer, or importing for self use or captive consumption, does not need producer registration, provided the supporting documents go to customs. Getting this wrong in either direction is costly.
Frequently asked questions
Is registration per product or per company?
Per entity, listing the EEE codes you deal in. Separate registration is needed where you are also a manufacturer, refurbisher or recycler.
What happens if we miss the target?
Environmental compensation applies, and the rate for the medical devices category is among the highest of the seven categories. A shortfall can be made good within three years, with a declining proportion of the compensation returned.
How long does registration last?
CPCB’s standard operating procedure states five years, with renewal to be applied for 120 days before expiry.
Do micro enterprises have to register?
The Rules do not apply to micro enterprises as defined in the MSMED Act, 2006.
What returns are required?
Quarterly and annual returns on the portal, on or before the end of the month following the period to which the return relates.