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- All X-ray machine registration with CDSCO as part of the Medical Device Rules, 2017, irrespective of pre-market approval from the FDA or CE marking from other countries.
- Depending on the diagnostic risk and function of the device, x-ray machines are classified as either Class C medical devices or Class D medical devices.
- Importers must apply for an import license using Form MD-14, and for manufacturers, a Device Master File and Plant Master File submission alongside ISO 13485 certification is required.
- The majority of the time it takes to register an x-ray machine with CDSCO takes between 6-15 months depending on the completeness of the documentation and the device classification.
- Working with regulatory companies, such as Diligence Certifications, will result in not only faster registration of the medical device itself, but also faster submissions, and appropriate follow up with authorities at CDSCO without any mistakes.
Introduction
Three months ago, a hospital in Chennai ordered an advanced digital X-ray machine from Germany. The machine arrived at the Mumbai port, cleared customs, and was ready for installation. To the hospital’s dismay, the machine could not be legally used in India since it lacked CDSCO registration. As a result, the hospital now had to keep the machine in storage while it worked through the registration process, losing time and money in the process.
Unfortunately, this scenario occurs more frequently than you realize. Many healthcare providers and importers think that having international certifications such as an FDA or CE certification is enough when importing a machine. It is not sufficient. Even if a machine is bought and certified in a foreign market, it still requires CDSCO registration to be sold or used in India.
If you are thinking of importing, manufacturing, or distributing X-ray machines , you are in the right place! This guide will provide you everything you need to know about CDSCO registration.
What is an X-Ray Machine?
Using electromagnetic radiation, X-ray machines take images of bodily structures internally. Soft tissues allow X-rays to pass through them, while denser structures, such as bones, absorb X-rays and therefore appear white on X-ray images. Softer tissues appear gray and air-filled areas appear the darkest. Modern digital X-ray machines result in clearer images and lessen exposure to radiation, while processing images faster and allowing easy sharing electronically with specialists.
Why X-Ray Machines Need CDSCO Registration
X-ray machines are considered medical devices. The Medical Devices Rules, 2017 elucidate that any device used for diagnosing, treating, or monitoring medical purposes, must be registered with CDSCO (Central Drugs Standard Control Organization).
CDSCO is the medical devices’ national regulatory authority in India. This is similar to the FDA in the U.S. and exists to ensure that any medical device sold in India meets the required safety and quality standards.
You will not be legally authorized to manufacture, import, sell, or use an X-ray machine, which was manufactured outside of India, unless it is registered with CDSCO. Hospitals, diagnostic centers, and clinics need to verify that the appropriate registration has occurred, prior to purchasing a medical device.
How X-Ray Machines are Classified Under CDSCO
Medical devices do not receive the same level of oversight: only certain categories of medical devices are reviewed in this manner. The CDSCO places medical devices in four categories, depending on the risk of harm to the patient.
Class A devices are low risk medical devices, like thermometers or tongue depressors, and these devices will not be subject to much oversight.
Class B devices pose low to moderate risk (“Devices posing moderate risk” designs, like hypodermic needles and certain suction devices).
Class C devices pose moderate to high risk (such as lung ventilators or certain diagnostic devices), and Class D devices pose the highest risk (such as heart valves, implantable devices, or life-support devices).
X-ray machines are usually Class C or Class D, depending on the type of x-ray machine and how it is used. While standard diagnostic x-ray machines used to prepare images for review are most likely Class C devices, specialized machines (fluoroscopy machines, interventional radiology machines, and specific types of diagnostic machines) may be classified as Class D.
The classification by CDSCO matters, as it will define the authority that approves your application and may change the documentation or the evidence that is required for your compliance with the regulation.
Who Needs to Register X-Ray Machines?
If you are engaging in any of these functions, then you will require CDSCO registration:
Manufacturers producing X-ray machines in India must register each of the models that they produce. This applies to both hospital-based film X-ray and other new digital systems.
Importers importing X-ray machines from anywhere outside India must have an import license, whether you are importing one unit for your own hospital or more.
Distributors of X-ray machines intending to sell in India also need to have some type of licensing all the way through. You cannot just buy X-ray machines from an importer and start selling them without registering.
Foreign manufacturers who intend to enter the Indian market must appoint an authorized representative in India who will take care of all regulatory affairs.
Even if your X-ray machine already has FDA, CE, or other international approvals, you would still require CDSCO registration independently. Indian law requires independent verification.
Documents Required for X-Ray Machine Registration
Required Documents for Registration of X-Ray Equipment
Complete documentation is required for CDSCO registration.
Manufacturers must present along with the application the manufacturing license, Plant Master File, Device Master File, ISO 13485 certificate, lab test results, and bilingual user manuals.
Importers must submit the Free Sale Certificate and manufacturer authorization, Certificate of Marketability, Device Master File, quality certificates, and Form MD-14 application for import license.
Safety test reports, clinical data, and risk analysis must also be submitted as part of the registration process. Failure to submit any documents will result in delayed X-ray registration for months.
Step-by-Step Registration Process
Let me break down how the registration actually works:
Outlined Procedure for CDSCO Registration
Step 1: Determine Device Classification
Establish if the X-ray machine is classified as either a Class C or Class D medical device, both of which will require a submission to the Central Licensing Authority (CDSCO).
Step 2: Authorize a Representative
Foreign manufacturers are to appoint a representative based in India and will require a wholesale drug license, either Form 20B or Form 21B, in order to proceed with the process.
Step 3: Gather Paperwork
The manufacturer must collect the requisite paperwork and have all documentations verified with the proper translations and in prescribed CDSCO registration form.
Step 4: Register on the CDSCO Site
Once you have all documents collected and verified, you must register on the official CDSCO portal. You will be required to create an account, provide your business details/information, and verify that credential.
Step 5: Submit forms and Payment
Importers will submit Form MD-14, while manufacturers will submit (Form MD-7). Both types of registrants will submit documents, pay ( if applicable) and will file online.
Step 6: Respond to questions
Respond promptly to any questions or requests for documentation and information that comes from a CDSCO inspection and/or review of documentation. There are cases that may require a review by a Subject Expert Committee.
Step 7: Facility Inspection (Manufacturers)
The CDSCO will conduct a facility inspection to determine compliance with GAAP requirements and the manufacturers Plant Master File.
Step 8: Receive Certification
Should finalized documents and approvals have been obtained, and for the importer, a Form MD-15 will be received and for the manufacturer Form MD-9, the CDSCO registration process will be complete.
How Long Does Registration Take?
Timelines are a common concern! Here’s how long you can reasonably expect:
For “complete” applications when no technical presentation is requested, the length of time is usually 6-9 months from the submission date until you are approved.
For applications that require a technical presentation or review by the Subject Expert Committee (often required for new X-ray technology or other types of complicated technology), add another 3-6 months.
So expect anywhere from 6 months to 15 months to complete your process. When working on any deadlines for hospital installation or equipment launch, start the application process as soon as you can.
Validity and Renewal of Registration
Your registration certificate is valid for three years from the date of issue and should be renewed, (ideally), at least nine months in advance of the expiration date. If you late renew your registration, your business activities may have to stop until you receive the new registration certificate.
To renew your certificate, you will have to submit your updated Plant Master File and Device Master File. In the case of renewal, if there are no changes to your original review your renewal process should be relatively simple. However, if you have made changes, particularly to your device or created a new manufacturing location you will need to provide additional information regarding the changes.
Common Mistakes That Delay Registration
Based on our experience working with medical device companies, we’ve noticed the following common problems:
Incomplete Documentation is often the biggest contributor. Missing ISO certificates, unregulated translations, or vague technical specifications all contribute to delays of several months.
Wrong Classification occurs when the applicant does not classify the device correctly.
Wrong Classification of Class C devices filed as Class B will need to be rejected.
Investing the appropriate amount of time into the Quality of Technical Files. Your Device Master File needs to be sufficiently detailed and professionally written. Missing technical specifications or vague description does not pass review.
Certificates are Expired. For example, ISO certification, Free Sale Certificate, and any other supporting documentation requires your research.
Insufficient Clinical Data for new or newer X-ray technology may lead to requests for additional products, testing, or clinical evaluation.
Communication breakdowns with foreign manufacturers can also extend timeline delays in getting the right documents. If you’re an importer, it is important to establish a method or follow-up process in communicating with foreign manufacturers.
What Happens After Registration?
Obtaining your certificate is only the beginning of your compliance responsibilities. You must continue to comply.
If there is any change to your company’s legal structure (for example, if you become a private limited company from a proprietorship), you must inform CDSCO of that change in writing within 30 days.
If you move your Registered Office or manufacturing site, you must inform the Licensing Authority. Your current certificate only remains valid for three months after the change, during which time you will need to apply for a new certificate.
You must report any adverse events involving and/or device failures to CDSCO per the vigilance requirements. This is for the sake of patient safety and meeting regulatory expectations.
If you want to add additional models of X-ray machines to your current registered devices, you will have to apply for an endorsement to your current certificate. This is an annual cost of USD 1,000 for each additional device if you are an importer.
The Cost of X-Ray Machine Registration
The total cost of registering an X-ray machine in India is impacted by numerous factors, such as classification of devices, quality of documentation, and testing. Full registration cost includes government fees, along with the costs for consultative assistance, technical documentation, any necessary testing and certification, and translation or notarization of foreign documents.
Organizations that do not yet hold ISO 13485 certification, as a part of their compliance process, may also need to consider costs for quality system certification.
Every project will be different, but most manufacturers and importers work with experienced CDSCO registration consultants, such as Diligence Certifications, to avoid complications and to ensure accurate documentation for quicker approvals with less delays.
Why Work With a CDSCO Consultant?
Although you can undertake registration on your own, many companies have established, through experience, that working with knowledgeable consultants saves time and money and will eliminate costly errors.
An experienced consultant knows what CDSCO is looking for in your documentation. They will ensure your Device Master File and Plant Master File are done appropriately the first time, and this will avoid potential rejections and additional resubmissions.
Consultants will normally have relationships with the officials at CDSCO, and this can create faster communication and clarification of regulatory requirements.
This is especially true for foreign manufacturers, who will value the ability of another person located in India to understand both technical requirements and applicable local regulations.
Diligence Certifications has worked with medical device companies to facilitate the registration process with CDSCO for over a decade. Our team has successfully registered medical devices, several types of X-ray machines, CT scanners, and other diagnostic imaging equipment.
Special Considerations for Different Types of X-Ray Machines
There are differences with the types of X-ray machines. Key considerations include:
Digital X-Ray Systems require documentation regarding validation of any software, cybersecurity (if the machine is networked), and verification that it complies with digital image quality standards.
Mobile X-ray Units require documentation that they have been certified for radiation safety standards considering they will be moved between rooms.
Dental X-ray Machines will require documentation on patient exposure limits and patient positioning safety.
Fluoroscopy Systems that provide live imaging may be subjected to even higher levels of scrutiny because of exposure to higher radiation levels and complexity of operation.
Mammography Equipment will have specialized documentation related to proper image resolution, compression, and routine quality evaluations.
In any case, it is important to understand all documentation is specific to the type of X-ray machine that you have.
Recent Updates to Medical Device Regulations
The CDSCO has been proactive in modifying its rules and regulations to be consistent with international requirements. Some recent changes include:
- The Medical Devices Amendment Rules, 2020 broadened the definition of medical devices and subjected more product categories to regulation.
- The new post-market surveillance obligations require manufacturers and importers to take proactive steps to monitor devices once on the market and report out-of-the-ordinary performance.
- There are new cybersecurity requirements for connected medical devices, such as X-ray machines connected to a network.
- Slightly more aggressive enforcement means there are more serious penalties now for not being compliant. For example, operating without a current registration may lead to confiscation of products, stop business operation, and even lead to criminal charges filed against responsible persons.
It is important to be aware of these changes to remain compliant.
If you’re ready to register your X-ray machine with CDSCO, start by gathering your documentation. The earlier you begin, the smoother the process will be.
For manufacturers, ensure your facility meets GMP standards before applying. For importers, establish clear communication with your foreign manufacturer to obtain all required certificates.
Consider the timeline carefully. If you’re planning to launch in the Indian market or install equipment at a specific date, work backward from that deadline and add buffer time for unexpected delays.
Most importantly, don’t operate without registration. The risks—both legal and financial—are simply too high.
Get Expert Help With Your X-Ray Machine Registration
The thought of registering with the CDSCO may feel overwhelming, but you are not alone. Diligence Certifications specializes in medical device registration, with experience helping more than 1,000 companies, just like yours, get their medical device licenses.
Our staff can help you through the documentation, submission of your application, and continuous compliance process whether you are importing your first X-ray machine or building a new manufacturing line.
So, are you ready to register your X-ray machine? Contact Diligence Certifications today to setup a free consultation for your project!
Frequently Asked Questions
What does CDSCO registration mean for X-ray machines?
The registration with the CDSCO is an obligatory approval required by India’s Central Drugs Standard Control Organization, which allows you to legally import or manufacture X-ray machines.
How do I register an X-ray machine in India?
To register an X-ray machine in India, you need to classify your device, prepare documents including the Device Master File and others, and apply to CDSCO through the website.
What are the documents needed for X-ray machine registration?
To register an X-ray machine you will need a Device Master File, a Plant Master File, an ISO 13485 certificate, a Form MD-14, and a Free Sale Certificate.
How long does it take for a CDSCO registration to complete?
Typically, for X-ray machine registration it takes 6 to 15 months to complete as it depends on your documentation and classification.
What is the expiry period when an X-ray machine is CDSCO registered?
The registration certificate lasts for three years before you must start again with another registration.
What forms are used to register an X-ray machine?
Importers will have to use Form MD-14, and manufacturers will use Form MD-7 for CDSCO registration.
Are X-ray machines Class C or Class D medical devices?
Depending on the type and use, X-ray machines may be classified as Class C or Class D medical devices.
Can I sell an X-ray machine without CDSCO approval?
No. It is illegal to sell or use X-ray machines and devices that are unregistered in India and may result in punishment.
Do I need ISO 13485 certification to register X-ray machines?
Yes, ISO 13485 certification is required from or for registrants for both manufacturers and importers for CDSCO registration.
