How to import medical equipment in India?

Nowadays, the increasing count of medical facilities is undoubtedly expected to skyrocket the demand for medical equipment in India. Additionally, several government initiatives like PLI (Production Linked Incentive) Scheme and medical parks will increase demand. Given the facts, the medical devices sector in India is estimated to reach 50 billion dollars by 2025. Surprisingly, the Indian medical device market is driven by 70-80% imports from nations like China, the US and Germany. In 2022, the government introduced the medical equipment in the E-waste (Management) Rules 2022 to ensure that the medical equipment imported into India is efficient, reliable and up to the required standards.

Before bringing any devices to the Indian market, knowing a bit about them is necessary. So, medical devices include a multi-disciplinary sector under its ambit with the following broad classification -

• Implants, Consumables and Disposables
• Electronic equipment
• Surgical instruments
• In-Vitro Diagnostic Reagents

In this blog, we will talk in detail about how to import medical equipment in India while complying with the EWM Rules.

The E-Waste (Management) Rules, 2022

EWM rules, 2022 apply to every importer, producer and other person engaged in the manufacture, sale, transfer, purchase, importing, and further processing of e-waste or electrical and electronic equipment (EEE) covered in Schedule I. Notably, the Schedule covers not only electrical and medical equipment but also their consumables, components, parts and spares which make the product operational.

Although necessary in most cases but EPR Authorisation is NOT required in the following scenarios -

1. Medical equipment import is for selling to EPR Authorised producers. Given that the importer prepares the documents given below for submission to Customs/Port Authorities;

• copy of agreements with EPR Authorised producers for whom the importer is importing
• copy of EPR Authorisation of the producer(s) for whom the importer is importing
• letter from EPR Authorised producers that the EEE importer is importing on his behalf.

2. The medical equipment which is not mentioned in Schedule - I of EWM Rules.

3. Bulk consumers or consumers if they import medical equipment in India for captive or self-use. Provided that the consumer or bulk consumer submits self-declaration on stamp paper mentioning that EEE items being imported are not for sale to Customs/Port Authorities but are purposeful for captive or self-use.

4. Import of spares (old or new) by actual users from original equipment manufacturers (OEM) for warranty replacement, given that an equal number of defective or non-functional parts are exported back within three sixty-five days as per the document verification by Custom Authorities as listed in Schedule VIII of Hazardous Waste and Other Wastes (Management and Transboundary Movement) (HOWM) Rules, 2016.

Apart from the cases above, EPR Authorisation does NOT apply to the following

EEE manufacturers, if they are manufacturing and/or importing medical equipment in India for selling, especially to EPR Authorised producers. Given that the manufacturer files the documents given below to Customs/Port Authorities -

• agreement copy with EPR Authorised producers for whom it is imported or manufactured;
• EPR Authorisation copy of the producer(s) for whom it is imported or/and manufactured;
• letter from EPR Authorised producers mentioning that the medical equipment is imported and/or manufactured on his behalf.

Besides the conditions related to EPR Authorisation for importing medical equipment in India, the rules also clarify specific terms. Let's gain some knowledge!

Extended Producer Responsibility (EPR) is EEE producers' responsibility for meeting recycling targets according to Schedule III and IV, only via registered recyclers of e-waste to make sure environmentally sound management of such waste;

The producer is an entity or a person who, -

3. List of documents to be given for obtaining registration from CPCB

• (i) offers to sell under its brand, assembled EEE and their components/parts/consumables/spares produced by other suppliers or manufacturers; or
• (ii) offers and manufactures to sell EEE and their parts/components/consumables/spares under its brand; or
• (iii) offers to sell imported medical equipment and EEE along with their parts/components/consumables/spares; or
• (iv) who imports used EEE; irrespective of the selling technique used like a retailer, dealer, e-retailer, etc.;

Extended Producer Responsibility Authorisation is permission the Central Pollution Control Board (CPCB) gives a producer to manage EPR with implementation plans and targets set in such authorisation, including information on Producer Responsibility Organisation (PRO) and e-waste exchange, if applicable.

Let’s now know how to register as an importer of medical equipment as per E-waste Management Rules 2022.

Let’s now know how to register as an importer of medical equipment as per E-waste Management Rules 2022.

(2) If the entity falls into more than one category, i.e., producer, then it must register under those categories such as recycler, refurbisher or manufacturer separately.

(3) All entities must conduct business with registration.

(4) The registered entities must not deal with other unregistered entities.

(5) Where any registered person provides false information or intentionally hides information for obtaining registration/report/return/details needed to be furnished or provided under these rules or in case of any irregularity, the registration of such person may be revoked by the CPCB for three years after giving a chance to be heard. Additionally, the CPCB can also impose environmental compensation charges in such cases.

• Payment of environmental compensation must not absolve the importer from the EPR as mentioned in these rules. The unfulfilled EPR for a specific year is carried forward to the following year & so on and up to three years.
• If the shortfall of EPR obligation is addressed after one year, the importer gets the 85% of the environmental compensation imposed.
• If the shortfall of EPR is addressed after two years, the importer gets the 60% of the environmental compensation imposed. If the shortfall of EPR obligation is addressed after three years, the importer receives the 30% of the environmental compensation imposed. After that, no environmental compensation is returned to the importer.

(6) The CPCB, with the approval of the Steering Committee (SC), may also charge annual maintenance charges and registration fees from the persons seeking registration under these rules depending on the capacity of e-waste generated/handled/recycled.

Here's the complete process to obtain the EPR Authorisation of producers for importing medical equipment in India.

(i) Every medical equipment importer must apply for EPR Authorisation in Form 1 to CPCB within ninety days from the date of these rules becoming effective;

(ii) on receiving the complete application, the CPCB evaluates the EPR Plan and, on being satisfied that the producer importing the medical equipment to India has established an effective system to manage EPR in India, must issue EPR Authorisation in Form 1(aa) within four months. The EPR Authorisation stands valid for five years;

(iii) the CPCB, after allowing the reasonable opportunity of being heard to the applicant, can refuse to grant EPR Authorisation;

refuse to grant EPR Authorisation; (iv) In case of refusal of EPR Authorisation by the CPCB, the importer losses his rights to place any medical equipment in the Indian market till the EPR Authorisation is issued;

(v) The CPCB, after issuing EPR Authorisation, must forward the EPR Plan to the concerned SPCB for evaluation;

(vi) a renewal application of EPR Authorisation must be made in Form 1 before four months of its expiry to CPCB. The Board may then renew the authorisation for five years after receiving the compliance report from the respective SPCB. In case of non-receipt of the compliance report from the SPCB within the stipulated two months, CPCB may renew the EPR Authorisation for the importer of medical equipment after analysing such case on a merit basis, subject to no report of violation of the Act/the rules/the conditions mentioned in the EPR Authorisation;

every person intending to import medical equipment in India must take all steps, wherever needed, to comply with the norms specified in the EPR Authorisation;

(vii) CPCB can conduct random checks, and if, in its opinion, the EPR Authorisation holder fails to comply with any of the authorisation norms/provisions of the Act/these rules and after allowing a reasonable opportunity of being heard, can suspend or cancel the EPR Authorisation for as long as it considers necessary;

(viii) The authorised importer must maintain records in Form 2 and shall file annual returns in Form-3 to the CPCB up to 30 th June annually;

(ix) The importer of medical equipment must submit the following-

• producer’s details
• authorised person’s details
• details of medical equipment placed in the market year-wise during the last ten years
• agreement copies with collection centres, dealers, recyclers, TSDFs (Treatment, Storage and Disposal Facilities)
• estimated EPR budget
• details for RoHS compliance
• the technical documents
• other documents like:
• EPR plan
• copy of the permission from the relevant Department/Ministry for selling their product;
• GST registration
• estimated production of EEE waste item-wise and collection target for the forthcoming year
• Hazardous Waste Authorisation
• copy of DGFT license/permission as applicable
• self-declaration regarding RoHS provisions
• any other document as required
• types & quantity of e-waste handled or generated
• MoA
• types & quantity of e-waste stored
• certificate of incorporation
• types & quantity of e-waste sent to a collection center
• Import Export Code
• types & quantity of e-waste transported

Responsibilities of the importer importing medical equipment in India

The medical equipment importer is responsible for -

(1) obtain and implement EPR targets according to Schedule III and IV via the portal: Given that the importer has an EPR plan under the E-Waste (Management) Rules, 2016 must migrate under these rules according to the process laid down by the CPCB with the approval of SC;

(2) aware people via publications, media, advertisements, posters or any other mode of communication;

(3) file quarterly and annual returns before the month end of the succeeding year or quarter, as it may be, to which the return relates.

E-Waste (Management) Amendment Rules, 2023

Recently an amendment was made to the EWM Rules 2022, termed E-waste Management Rules 2023.

As per the new amendment, the following applications are exempted from sub-rule (1) requirements of rule 16 of EWM Rules, 2022.

As mentioned in Schedule- I, lead in Medical Devices (except all infected and implanted products).

Liability of importer of medical equipment to India

(1) The importer of medical equipment is liable to pay financial penalties as imposed for violating any provisions under these rules by the SPCB with the prior consent of the CPCB.

(2) The medical equipment importer is liable for all damages caused to the third party or environment because of improper e-waste management and handling.

(3) If an accident occurs at the facility processing e-waste or while transporting the e-waste, the importer must report immediately to the respective SPCB about the accident through e- mail and telephone.

Importing medical devices in India also involves following the EPR regime's specific modalities.

(1) All importers must fulfil EPR obligations under Schedule-III and IV. But, in doing so, they can take the help of third-party organisations like collection centres, producer responsibility organisations (PROs), dealers etc. However, this is contigent upon condition that the EPR shall only lie entirely on the producer (importer).

(2) The EPR for each item is decided depending on the details furnished by the producers on the portal and the individual product’s life period as framed by the CPCB and the targets mentioned in Schedule-III and IV.

(3)

• (i) The importer intending to import medical devices to India must fulfil their EPR via the online purchase of an EPR certificate from registered recyclers only and submit it online by filing a return quarterly.
• (ii) The info given by the registered recycler and producer must be cross-checked on the portal.
• (iii) In case of any difference, the lower figure is regarded towards fulfilling the producer's EPR obligation.
• (iv) The certificates may be subject to environmental audit by the CPCB or any other agencies authorised by the CPCB in this regard.

The norms of ERP Authorisation are more relaxed than they appear. There is a provision for the transaction of EPR certificates. Here's how to do it.

(1) A importer may buy EPR certificates restricted to its EPR liability of the current year (Year Y) plus any leftover liability of previous years plus 5 per cent of the current year's liability.

(2) The EPR obligation must be fulfilled by the importers importing medical equipment in India by proportionately buying the EPR certificate every quarter.

(3) As soon as the importer buys an EPR certificate, it is automatically adjusted against its liability. However, the priority in adjustment is given to previous liability and the EPR certificate, so adjusted is automatically cancelled and extinguished.

(4) As soon as the importer buys refurbishing certificates, its EPR liability is automatically deferred for the relevant product quantity for the period laid down by the CPCB.

(5) The requirement, availability and other info on the EPR certificate and refurbishing certificates for every importer are available on the portal.

Reduction in the usage of hazardous substances in the manufacture of medical equipment and their spares/components/consumables/parts

(1) Every importer of medical equipment must ensure that new EEE or imported EEE and their spares/components/consumables/parts or don't have Mercury, Lead, Cadmium, polybrominated biphenyls, Hexavalent Chromium and polybrominated diphenyl ethers above a maximum concentration value of 0.1% by weight in homogenous products for lead, hexavalent chromium, mercury, polybrominated diphenyl ethers and polybrominated biphenyls of 0.01% by weight in homogenous materials for cadmium.

(2) Parts/components/consumables/spares needed for the medical equipment placed in the market before 1 st May 2014 may be exempted from the norms of sub-rule (1) given that RoHS-compliant spares and parts aren't available.

(3) The applications mentioned in Schedule II are exempted from norms of sub-rule (1).

(4) Every importer must comply with the limits of hazardous substances mentioned in Schedule II.

(5) Every importer importing medical equipment in India must furnish complete information on the constituents of the equipment and their consumables/components/parts/spares, in addition to a declaration of conformance to the RoHS norms in the product user documentation.

(6) Imports or putting in the market for new EEE must be allowed only for those which are compliant with norms of sub-rules (1) and (4).

(7) Every importer must provide details on the compliance of the norms of sub-rule (1), and this detail must be in terms of self-declaration.

(8) The CPCB must randomly sample medical devices imported and placed in the market to evaluate and verify compliance with RoHS norms. However, the producer must bear the cost of testing and sampling. Moreover, the random sampling must be according to the criteria framed by the CPCB.

(9) If the medical equipment doesn't comply with RoHS norms, the importer must take corrective measures to bring the product into compliance and recall or withdraw the product from the market within a reasonable interval according to the norms framed by CPCB.

(10) The CPCB must frame the methods for sampling and analysis of hazardous substances as mentioned in sub-rule (1) concerning the products mentioned in Schedule-I and II and propose the labs for the said purpose.

Here's how to appeal against the registration's cancellation/refusal/suspension.

(1) The importer aggrieved by cancellation/suspension/refusal of registration or its renewal passed by the CPCB, within one month from the day the order is communicated to him, prefers an appeal to the Additional Secretary or Joint Secretary, MoEF&CC duly nominated by the Central Government regarding this.

Learn more about Environmental Compensation below.

(1) False details resulting in over generation of EPR certificates by the recycler must lead to revocation of registration and imposition of environmental compensation, which shall not be returnable and repeat offence. Moreover, violation of the rules three times or more must also result in permanent revocation of registration over and above the environmental compensation charges.

(2) The funds collected under environmental compensation are reserved in a separate Escrow account by the CPCB.

(3) With the consent of the MoEF&CC, the SC decides the modalities and heads for using funds.

Be aware of the prosecution and fine if you violate any of the norms.

If any person importing medical equipment in India provides incorrect information to obtain EPR certificates, causes to be used or uses forged or false EPR certificates in any way, intentionally violates the instructions given under these rules or fails to cooperate in the audit and verification proceedings, will be prosecuted under section 15 of the Act, 1986. Moreover, this prosecution will be in addition to the environmental compensation imposed under rule 22.

Here’s the complete process explaining how verification and audit take place.

The CPCB, via an authorised agency or by itself, will verify compliance with these rules by PIBOs via periodic audits and random inspections. If found guilty, the Board then take action against violations of the norms of these rules as deemed fit.
Last but not least, update yourself about the categories of medical equipment along with their spares, components, parts and consumables covered under the rules.

Medical Devices (Except All Infected and Implanted Items)

• Radiotherapy equipment and accessories - MDW1
• Cardiology equipment and accessories - MDW2
• Dialysis equipment and accessories - MDW3
• Pulmonary ventilators and accessories - MDW4
• Nuclear medicine equipment and accessories - MDW5
• Laboratory equipment for in vitro diagnosis & accessories - MDW6
• Analysers and accessories - MDW7
• Magnetic Resonance Imaging (MRI), Computed Tomography (CT) Scanner, Positron Emission Tomography (PET) Scanner & Ultrasound Equipment along with accessories - MDW8
• Fertilisation tests equipment and accessories - MDW9 Other electric equipment/appliances/kits used for screening, preventing, detecting, monitoring, reviewing, evaluating, examining, investigating, treating illness sickness, probing, disease, disorder, infection, affliction, injury, trauma, disability or abuse, including the Tablets, Mobiles, or any other equipment with the features having the capability of sex selection and their accessories - MDW10

Take a look at E-waste Recycling Target according to the EWM Rules, 2022, before importing medical equipment in India.

Before knowing about the targets, it must be noted that the importers of used electrical and electronic equipment shall have a 100% extended producer responsibility obligation for the imported material after the end of life if not re-exported.

Once you fulfil all these obligations, you can easily import medical equipment to India without any further ado.