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CDSCO Issues New Guidelines for the Sale of IVF Media, Reagents & Related Consumables Used in ART Procedures

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CDSCO Issues New Guidelines 2026

CDSCO Issues New Guidelines for the Sale of IVF Media, Reagents & Related Consumables Used in ART Procedures

Recently, the Central Drugs Standard Control Organisation (CDSCO) issued a circular bearing the number CDSCO/L&R/04/MDD/2026-27 referring to certain requirements in terms of compliance in respect of sales of in vitro fertilisation (IVF) media, reagents and other consumables used in the process of assisted reproductive technology (ART). The Medical Devices Division, Directorate General of Health Services, Ministry of Health & Family Welfare, has released the circular.

These products are governed by the Medical Devices Rules, 2017, and are governed by the relevant licence for their manufacture/import under the circular. Most importantly, CDSCO issues new guidelines and instructs all stakeholders to make sure that these products are only provided to ART clinics and ART banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.

The IVF product manufacturers, importers, distributors, and suppliers should be aware of these new requirements to keep their business running smoothly and comply with regulatory requirements.

Why Has CDSCO Issued This Circular?

With the increasing use of assisted reproductive technology services across India, the usage of IVF media, reagents, and related consumables has also increased significantly. The quality and controlled distribution of these products is critical to ensure patient safety due to their direct impact on embryo handling, fertilisation, cryopreservation and other laboratory practices.

Certain IVF media and related consumables were being provided to institutes and medical centres that were not registered under the ART (Regulation) Act, 2021, posing a threat to public health and ethical use of reproduction, CDSCO noted.

To improve the regulatory control, the stakeholders are advised to sell and supply such products to ART clinics and ART banks, which are registered under the applicable regulations only.

IVF Products Covered Under the Circular

The circular applies to medical products used during assisted reproductive technology procedures, such as the following:
Product Category Regulatory Status
IVF Media
Regulated under Medical Devices Rules, 2017
IVF Reagents
Regulated Medical Device
Cryopreservation Media
Covered under the Circular
Embryology Media
Applicable
Related Consumables used in ART Procedures
Covered under the Circular

They are used-only products used in ART procedures and subject to the provisions of the Medical Devices Rules 2017.

Major Compliance Requirements Introduced by CDSCO

The new circular adds a few key regulatory requirements for stakeholders in IVF products.

1. Supply Only to Registered ART Centres

By this, manufacturers, importers, distributors and suppliers must ensure that they supply IVF media, reagents & related consumables to ART clinics and ART banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.

2. Adherence to Medical Devices Rules 2017

These products continue to be regulated as medical devices. Such a manufacturing or import licence will have to be obtained before the product is marketed in India under the Medical Devices Rules, 2017.

3. Strengthened Patient Safety

To further enhance the regulatory control, the circle provides new products that can only be employed in permitted health care facilities, minimising chances of inappropriate use or handling of IVF products

4. Ethical Healthcare Practices

CDSCO's move is to ensure ethical reproductive health care practices and accountability across the entire ART ecosystem through restrictions in the supply chain.

CDSCO Approval Process

Within a well-organised regulatory framework, CDSCO registration is a methodical process:

Step 1: Product Classification –

Identify whether the product is a drug, medical device, cosmetic, or diagnostic according to CDSCO definitions.

Step 2: Application Submission –

Setting up and submitting the online application through the CDSCO portal should be accompanied by payment of the corresponding fees for CDSCO registration.

Step 3: Documentation Review –

CDSCO scrutinises the technical, clinical, and quality documents.

Step 4: Inspection (If Applicable) -

Inspectors may go to a production site to see how the site is following GMP.

Step 5: Grant of Approval –

Based on the positive outcome of the review, CDSCO will provide the CDSCO certificate, CDSCO registration certificate, or CDSCO licence. Product Compliance Services UMS Pvt. Ltd. is your partner during the various phases of the CDSCO approval process, making sure that everything is precise and compliant with the rules.

Documentation Required for CDSCO Approvals

The most important factor in getting a successful CDSCO certificate is to have the right documents. Typical documents are the following:
  • Application Form (as per CDSCO format)
  • Device Master File (DMF) or Drug Master File
  • Free Sale Certificate
  • ISO 13485 or GMP Certificates
  • Clinical evaluation or performance data
  • Product labeling and IFU
  • Power of Attorney (for importers)
  • Manufacturing license
  • Charge payment receipt for CDSCO registration
UMS Product Compliance Services regulatory specialists. Ltd. is constantly dedicated to creating flawless documentation that satisfies CDSCO requirements, reducing the likelihood of delays and rejections.
  • Fees for CDSCO Registration
  • CDSCO registration fees depend on:
  • Product category
  • Risk classification
  • Domestic or imported status
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Types of CDSCO License Required

The type of CDSCO licence, irrespective of whether you’re a manufacturer, importer, or distributor, is mentioned below:
  • Import license (Form MD-14 / MD-15) - Needed for the delivery of medical devices.
  • Manufacturing License (Form MD-5 / MD-9) – Required for manufacturers who are dealing with drugs and medical devices within India.
  • Loan License- For businesses that use the facilities of another licensed manufacturer to produce in India.
  • Wholesale License - Required for manufacturers who produce or sell in bulk quantities of drugs and specific medical products.
  • Retail License - Needs to be implemented for the purpose of selling drugs and medical devices directly to customers.
  • Registration Certificate for Cosmetics – It’s required to import cosmetics into India.

Classification of Medical Devices in India

In India, medical devices are categorised according to their type of danger. Regulatory scrutiny, documentation, and the approval process are all affected by the classification.
  • Class A (Low Risk): Basic tools and dressings for surgery
  • Class B (Minor to Medium Risk): Suction devices and needles
  • Class C (Medium to High Risk): Breathing machines and infusion devices
  • Class D (High Risk): Implantable equipment and cardiac valves
More rigorous assessment, including complete technical information and clinical proof, must be undertaken for more dangerous devices.

Timeline of the Regulation

Date Regulatory Development
2021
The Assisted Reproductive Technology (Regulation) Act, 2021, was enacted.
2021
Surrogacy (Regulation) Act, 2021, was enacted
23-Jun-26
CDSCO issued the circular restricting the supply of IVF media, reagents, and related consumables
Current
Stakeholders should ensure supply only to registered ART clinics and ART banks.

What Manufacturers Should Avoid in Common Compliance Mistakes

Many organisations inadvertently put themselves at risk of compliance issues because they are not adequately verifying.Some of the common mistakes are the following:They should:
  • Confirm ART clinics' and ART banks' registration with customers.
  • Make sure that products are made or imported under an appropriate medical device licence.
  • Keep good sales and distribution records.
  • Examine internal supply verification compliance.
  • Update and train sales and distribution staff on the changes in CDSCO regulations.
Taking these steps early can help to prevent a business from facing regulatory challenges and being unable to function

What Will Happen If Businesses Refuse To Comply?

Compliance with the updated CDSCO issues new guidelines 2026 could lead to regulatory probes and action in terms of the following provisions of the Medical Devices Rules, 2017, and other applicable healthcare laws.

Non-compliance may also lead to the following:

  • Supply chain disruptions.
  • Regulatory investigations.
  • Increased compliance obligations.
  • Coping with the dangers to patient safety.
  • Manufacturers and distributors' reputational damage.

Therefore, it is imperative that businesses make sure that only IVF products are supplied via authorised channels.

Common Compliance Mistakes to Avoid

Many organisations inadvertently put themselves at risk of compliance issues because they are not adequately verifying. Common errors are:
  • Offering products without checking ART registration.
  • Poor record-keeping of customers.
  • Failure to keep records of distribution.
  • Failure to be aware of the latest requirements of CDSCO.
  • Putting on the back burner internal compliance reviews.
Defining correct verification and documentation procedures can help to minimise regulatory risks considerably.

How UMSPCS Can Help

UMS Product Compliance Services Pvt. Ltd. (UMSPCS) helps medical device manufacturers, importers, and medical device enterprises to understand and follow CDSCO regulations.

Our services include:

  • Medical device regulatory consultation.
  • Assistance with medical device licences.
  • Product applicability assessment.
  • Documentation preparation/review.
  • Regulatory compliance support.
  • Import compliance assistance.
  • Advisory services by the CDSCO from end-to-end.

UMSPCS has 6+ years of experience in the regulatory field and has completed a successful portfolio of 600+ compliance projects in India to help businesses manage their changing medical device regulations with effective efficiency.

Conclusion

The issuance of the CDSCO circular on 23 June 2026 is a significant regulatory move towards the safe and ethical usage of IVF media, reagents and other consumables in India. The government's objective by restricting the supply to registered ART clinics and ART banks is to enhance patient safety, regulatory compliance and accountability in ART services.

The manufacturers, importers, distributors and suppliers should check their supply chain and ensure 100% compliance with the Medical Devices Rules, 2017; the ART (Regulation) Act, 2021; and the latest directions of CDSCO. Businesses will be able to operate normally while the safe use of reproductive health is maintained when timely action is taken.

Looking for medical device compliance assistance with CDSCO issues new guidelines

As a manufacturer/importer/distributor/supplier of IVF media, reagents, and related consumables, you can fulfil all your regulatory needs as per medical device compliance, licensing, documentation, and CDSCO requirements from UMSPCS.

Please reach out to UMSPCS today and help your IVF products meet the updated standards of the CDSCO and the medical device rules.

Frequently Asked Questions (FAQs)

On 23 June 2026, CDSCO issued a circular to limit the sale of IVF media, reagents, and other IVF-related consumables to ART clinics and ART banks.

 

Yes, IVF media, IVF reagents, IVF cryopreservation media, and IVF consumables are considered medical devices in the Medical Devices Rules, 2017.

Only ART clinics and ART banks registered under the ART (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021, should be supplied with these products.

 

Yes, it is necessary that all the manufacturers or importers hold the requisite licence under the Medical Devices Rules 2017.

 

This circular was issued with the motive to prevent the supply of IVF products to unregistered clinics.

 

Medical device licensing, documentation, regulatory compliance, and CDSCO approval assistance are offered by UMSPCS end-to-end.

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