Can Import Medical Devices Without CDSCO Registration in India? Rules Explained

Has your medical device arrived at a port in India, or can it be legally sold there?

Just because a product has been approved in its home country does not mean that it is automatically allowed for commercial import into India. For any business that is engaged in importing medical devices into India, it is essential to understand both CDSCO registration and import licensing before shipping the products to the country.

Does it follow that every medical device needs to obtain approval from the CDSCO? By no means. The majority of medical devices need the appropriate import licence pursuant to the Medical Devices Rules, 2017, whereas Class A non-sterile and non-measuring devices are exempt from the requirement for a licence, provided that the relevant registration requirements are met.

In this blog, we set out the rules, classification, documents, procedure, timeline, validity, challenges, and the main requirements concerning CDSCO certification in India for those who import medical devices.

Is it Possible to Import Medical Devices Without Obtaining Approval from the CDSCO?

The CDSCO says that to market medical devices in India, it is necessary to obtain an import licence pursuant to the Medical Devices Rules, 2017; for the majority of devices, the application is submitted in Form MD-14, and the import licence is then issued in Form MD-15 by the Central Licensing Authority.

There is, on the other hand, a particular exception relating to Class A non-sterile and non-measuring medical devices.

These devices do not need an import licence. However, the importer or manufacturer must complete the required registration process and get a system-generated registration number. CDSCO also requires them to follow the labelling rules and standards that apply.

One cannot merely assume that a product is a “low-risk medical device”; it is necessary to verify its exact classification against the current CDSCO classification framework.

Understanding the CDSCO Medical Device Classification

Prior to beginning the CDSCO Certification for Medical Devices process, the product has to be classified on the basis of its risk.

Under the Medical Devices Rules, 2017, medical devices are broadly classified as:

The classification takes into account factors such as intended use and other criteria specified in the First Schedule to the MDR 2017; the classification lists maintained by CDSCO are subject to revision.

Why Do You Need a CDSCO Import Licence?

When it comes to importing medical devices into India, an import licence is usually necessary unless the product is covered by a particular exemption.

The usual procedure involves submitting Form MD-14 for regulatory review and then Form MD-15, the Import Licence. CDSCO makes it clear that if an applicant wishes to obtain an import licence, they must submit Form MD-14 together with the relevant documents listed in the Fourth Schedule and the applicable fee specified in the Second Schedule of the MDR 2017.

The overseas manufacturer and the Indian authorised agent are both essential components of the application structure for an imported device.

Who is Eligible to Apply for Approval from the CDSCO for the Import of Medical Devices?

Usually, an overseas manufacturer obtains the necessary import licences via an Authorised Agent in India.

To complete the MD-14 application, information is needed about the authorised agent, the overseas manufacturer, and the manufacturing site, as well as details of the medical devices that are proposed to be imported.

The authorised agent therefore has an important role to play in coordinating the regulatory submission and in communicating with the Indian licensing authority.

Documents Required for CDSCO Certification for Medical Devices

The exact document list depends on the product and regulatory pathway, but an import application can involve documents such as:

• Cover letter 
• Company constitution
• Proof of ownership of premises
• Plant Master File
• Device master file
• List of essential principles
• Risk management file
• ISO 13485 (quality management system)
• Inspection/Audit report
• Payment receipt (Challan)
• Plan of premises
• Test license on MD13 form

The current CDSCO portal and the relevant device-specific requirements should always be used to verify the final checklist.

How to Get a CDSCO Import Licence: Step-by-Step Process

Step 1: Determine Device Classification

State the device category and risk class according to the Medical Devices Rules, 2017.

• Class A, B, C, or D
• Intended use
• Technical features
• Risk and invasiveness
• Applicable CDSCO rules

Step 2: Prepare Documents

Gather the documents needed for the regulatory pathway that applies.

• DMF
• PMF/SMF, where applicable
• ISO 13485 certificate
• Test reports
• Risk management documents
• Labels and IFU
• Manufacturer/importer details

Step 3: Prepare the Application

Fill out the CDSCO application that applies with correct details about the product and the applicant.

• Select the correct form
• Add product and model details
• Mention classification and intended use
• Provide manufacturer/AIA details
• Upload supporting documents

Step 4: Submit Online

Submit the application via the relevant CDSCO online system.

• Upload documents
• Pay applicable government fees
• Verify details
• Save acknowledgement

Step 5: CDSCO Review

The CDSCO looks at the application and the supporting documents.

• Technical scrutiny
• Document verification
• Regulatory queries
• Submit clarifications
• Inspection, if applicable

Step 6: Obtain Licence or Approval

When the requirements have been met, the CDSCO issues the relevant approval.

• Import/manufacturing licence
• Follow labelling requirements
• Maintain quality records
• Meet post-market obligations

CDSCO Certification Cost for Medical Devices

The amount required to obtain CDSCO Certification for medical devices is not fixed; it varies according to the device’s classification, the testing involved, the documentation needed, the regulatory pathway chosen, and whether the device is made in India or is imported.

The government fees are set out in the Second Schedule to the Medical Devices Rules, 2017 and differ depending on the relevant regulatory pathway.

CDSCO Certification Timeline for Medical Devices

The time taken to obtain CDSCO Certification in India will depend on the classification, the documentation, the testing, the level of regulatory examination, and the completeness of the application.

The timelines given here are only indicative; the actual process may differ because of testing requirements, queries from the CDSCO, inspections, further documentation, or other regulatory conditions.

What Will Happen if You Import Without the Necessary Approval?

It is possible to encounter serious compliance problems if you import a regulated medical device without carrying out the relevant CDSCO requirements.

Potential consequences can include:

• Customs or port-related delays
• Difficulty clearing consignments
• Regulatory queries
• Commercial disruption
• Product withdrawal or corrective action
• Compliance exposure for the importer
• Additional documentation and regulatory costs

The exact consequences will vary according to the particular facts of the case and the relevant legal provisions, so importers should make sure to establish the regulatory pathway before shipping the product to India.

What are the Advantages of Finishing CDSCO Compliance Before Importing?

Obtaining the applicable approval before commercial import helps businesses:

• Establish a legally compliant import pathway
• Reduce avoidable shipment-related issues
• Prepare documentation before commercial launch
• Support smoother regulatory communication
• Build a structured compliance record
• Maintain ongoing regulatory compliance after approval

International manufacturers who are entering the Indian market can also benefit from an early regulatory assessment, as it will help them to spot any gaps in their documentation before shipping the products.

How UMSPCS Helps With CDSCO Certification in India

In India, the process of obtaining CDSCO certification can become complicated since the product classification and the documents from the overseas manufacturer, as well as the technical files, the quality certificates, and the regulatory submissions, all have to be coordinated.

UMSPCS has more than six years of experience in connection with over 600 product compliance cases and thus offers regulatory compliance support to manufacturers, importers, and companies that are involved with medical devices and other regulated products.

Our support can include:

• Medical device regulatory pathway assessment
• Product classification support
• Documentation and dossier preparation
• Authorised Agent documentation support
• PMF and DMF documentation coordination
• CDSCO application preparation
• SUGAM/online filing assistance
• Regulatory query and deficiency-response support
• Coordination with manufacturers and laboratories
• Post-approval compliance guidance

Conclusion

Is it possible to bring in medical devices without having CDSCO registration in India?

In most cases, the answer is no for medical devices that are intended for commercial marketing; an applicable CDSCO import licence is usually necessary, although there is a regulatory exception concerning Class A non-sterile and non-measuring devices, which are subject to registration instead of the normal import-licensing requirement.

There are also dedicated routes for particular purposes such as testing, evaluation and clinical investigation.

The safest course of action is to establish the regulatory pathway before the goods leave the exporting country since medical device requirements vary according to classification, intended use, manufacturer, manufacturing site, and the purpose of import.

Are you planning to bring a medical device into India? 

Connect with UMSPCS to have your product classification, the documentation, and the relevant CDSCO compliance pathway assessed.

Read more also: How to Apply for BIS Registration Online India?

FAQs

1. Is it necessary to have CDSCO registration when importing a medical device into India?

A licence for the import of most medical devices intended for marketing in India must be obtained under the MDR 2017; however, Class A non-sterile and non-measuring devices are exempt based on registration.

2. What regulates the CDSCO import license for medical devices?

The application for the regular license is made through Form MD-14; the import license is granted by the Central Licensing Authority through Form MD-15.

3. Is it allowed to import Class A medical devices without holding a CDSCO certification?

The requirement for a license is not applicable to Class A devices that are specifically non-sterile and non-measuring devices, although these devices must still be registered and adhere to relevant regulations.

4. Is CDSCO certification equivalent to a CDSCO import licence?

“CDSCO certification” is used as a general term in the industry. In the case of imports of medical devices, the necessary formal regulatory approval is usually the import licence in Form MD-15.

5. Is it possible to import a medical device for testing without having an MD-15 licence?

There is also a separate procedure for importing as a test. When applying for a test import licence, Form MD-16 is used, and the licence itself is then issued on Form MD-17, provided that the relevant requirements are met.

6. What is the reason for consulting a CDSCO medical device consultant before importing?

A regulatory consultant will be able to assist in determining the product’s classification, the appropriate import route, the documentation requirements, and the filing procedure prior to the product being shipped commercially, thus reducing the risk of compliance gaps that could have been avoided.