MD-12 Test License for Medical Devices in India | CDSCO Approval
The MD-12 test license is an essential part of India's medical device regulatory ecosystem. It allows manufacturers to test, evaluate, and validate their products under CDSCO-approved conditions before a larger-scale launch.
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MD-12 Test License for Medical Devices in India | CDSCO Approval
The MD-12 test license is an essential part of India's medical device regulatory ecosystem. It allows manufacturers to test, evaluate, and validate their products under CDSCO-approved conditions before a larger-scale launch.
This license shall support real performance checks, safety reviews, and controlled trials to help innovators refine every feature with confidence. With an MD-12 test license, teams can safely assess device behaviour in realistic settings and gather robust data for regulatory submissions.
To obtain this CDSCO medical device license, manufacturers need to submit a Form MD-12 application to the CDSCO. It is a must for the part to be proper and thorough with the application to be able to enjoy an easy approval and regulation compliance.
If you want to get MD-12 licensing in an easy way, be sure to make a call to ComplifyXpert right away!
What is MD-12 License?
MD-12 License is basically permission for the manufacturers to produce medical devices only for the purpose of testing, validation, examination, or clinical investigations, and not for commercial sale. Such a license works as a device-maker's regulatory gateway to the market, where testing of safety, performance, and functionality can be done in the first place.
The official Form MD-12 application requires clear information about the device, its purpose, and the facility where it will be manufactured. The licence confirms that the proposed activity aligns with the Medical Devices Rules, 2017, and supports structured evaluation under controlled conditions.
Types of Medical Devices
Medical devices fall into several categories, which serve a unique purpose in patient care, diagnosis, treatment, or safety.
Class A - Basic Low Risk Devices
This group includes simple tools that present minimal risk and are mostly non-invasive. Devices such as thermometers, stethoscopes, wheelchairs, examination gloves, and hospital beds fall under this class. These products involve straightforward usage and require the least regulatory involvement under MDR 2017.
Class B - Low to Moderate-Risk Devices
This segment covers devices that involve a slightly higher risk and moderate operational complexity. Nebulisers, suction units, contact lenses, BP monitors, dental chairs, and oxygen concentrators are common examples. These products may be used invasively for a short duration and require structured documentation.
Class C - Moderate to High-Risk Devices
This category includes devices that influence critical diagnostics for therapeutic functions. Ventilators, ultrasound systems, anaesthesia machines, dialysis equipment, and several implants fall here. These require extensive validation, performance data, and strong quality controls.
Class D - High Risk, Life-Supporting Devices
This class represents the highest safety priority, covering life-sustaining and long-term implants. Pacemakers, cardiac stents, heart valves, implantable defibrillators, and certain IVD kits for serious infections belong here. These devices undergo rigorous clinical review and stringent regulatory scrutiny.
Eligibility
Applicants who wish to obtain a medical device clinical trial license India have to fulfil certain requirements under CDSCO. For instance, manufacturers are expected to operate a legally registered company along with a dedicated facility that follows Good Manufacturing Practices.
Production activities and quality checks should be handled by a skilled technical team. Proper equipment, controlled environments, and documented procedures at the facility will support safe test manufacturing.
Key eligibility points include:
- A valid business registration and approved manufacturing premises.
- A facility that adheres to GMP standards, along with basic infrastructure.
- Qualified personnel should be available to direct production and control measures.
- Complete documentation, including the Device Master File and Plant Master File.
- Depending on the classification of a device, i.e., Class A B C D medical devices, further approvals might be required.
The main reason for these requirements is to guarantee that a product is safe, reliable, and meets the regulations during manufacturing and testing.
Documents Required
Applications for an MD-12 Test License have to be made with a detailed set of documents that demonstrate the ability of the applicants to manufacture devices only for testing and evaluation. The submission shall allow CDSCO to review the technical readiness of the facility, the capability of the workforce, and due compliance with the provisions of the Medical Devices Rules, 2017.
Each document serves to confirm that the proposed activity will be undertaken safely under controlled conditions. Applications are filed through the CDSCO registration Sugam Portal, which is the official platform for license processing.
Key documents include:
- Form MD-12 and a Covering Letter describing the device, its purpose, materials, and also intended use.
- Details of premises, including a systematic layout showing raw material storage, process areas, and finished goods sections.
- Personnel and equipment lists, covering skilled staff and manufacturing and testing machinery.
- Quality documents, such as QMS certificates including ISO 13485, test protocols and supplier quality certificates.
- Device Master File and Plant Master File describing the design, manufacturing process, labelling, and site capabilities.
- Justification for the quantity requested for test production.
- Fee challan and legal undertakings confirming payment and regulatory compliance.
These documents facilitate a smooth, transparent review process that enhances regulatory trust in your test manufacturing setup. Connect with ComplifyXpert to simplify the documentation, filing, and end-to-end MD-12 licensing support.
Application Process
Applicants should follow a structured online procedure to obtain the CDSCO medical device license.
Step 1: Registration on the Sugam Portal
The first step for applicants involves account creation on the Sugam Portal. Sugam portal registration allows an individual to access the online licensing system to be used for all medical device applications. Correct information must be provided, as this would enable efficient communication and processing at every step of the approval procedure.
Step 2: Application Preparation
The applicants shall compile all the details required under MDR 2017 and prepare a complete CDSCO Form MD-12 application process regarding the MD-12 Test License. A draft must have details about the device, the purpose of the test, manufacturing, the facility, and other supporting data that show a clear and compliant submission.
Step 3: Mandatory Documents Upload
Applicants must upload documents as per the checklist provided in the MD-12. Supporting documents may include technical files, information on facilities, staff qualifications, and operational details. Every document shall be prepared in the format of the CDSCO so that delays do not happen in verification or review.
Step 4: Paying the Government Fee
The applicant must pay the corresponding fee as specified for the MD-12 Test License. Payment is made through the designated online system on the portal. Such a fee receipt forms part of the application record and supports the initiation of the final review.
Step 5: Submission of Application
Once the application is filled out, it should be submitted along with the documents that are uploaded and the payment that is made through an online medical device testing India portal. The authorities get a copy of the submitted file for scrutiny, followed by questions, explanations, or approval according to their review.
Timeline
The MD-12 Test License has a structured review from the CDSCO, and it usually takes a general processing window (2 to 4 months, approximately) based on the regular regulatory flow. The authority examines the purpose of test manufacturing, verifies the documents, and checks the readiness of the facility before giving the final approval in the form of an MD-13 License. The entire period can differ depending on the quality of the submission and whether any follow-up questions will be asked during the evaluation.
Typical timeline expectations include:
- Purpose of Application: Manufacturing for clinical investigation or performance evaluation.
- Application Device Classes: This process applies to all categories.
- Reviewing Authority: Assessment and approval which are done by CDSCO.
- Final Result: Issuance of the MD 13 license upon favourable review.
- Anticipated Duration: Approximately 2 to 4 months based on average processing trends.
This general timeline aids the applicants in planning their submission more efficiently.
Benefits
MD-12 is significantly instrumental in enhancing the regulatory journey that eventually results in the safe assessment and legal market access of medical devices in India.
Regulatory Compliance
The manufacturing test approval confirms that the test manufacturing process conforms to CDSCO requirements. It supports safe development practices and helps manufacturers align their products with essential regulatory standards before moving ahead in the approval cycle.
Clinical Evaluation Support
The manufacturer receives the right to manufacture devices solely for the purpose of clinical testing and performance evaluation. A clinical investigation license provides a controlled assessment that ensures a device works well in real conditions before taking complete commercial approval.
Quality Assurance
The MD-13 certificate, along with MD-12, requires very strict and detailed documentation as well as the implementation of quality management systems. These elevated standards lead to regular production processes that ensure the safety of patients, with stability throughout the test phase.
Safety and Risk Reduction
The strict regulatory checks minimise the possibilities of unsafe or malfunctioning devices passing through the later stages of approval. This protective approach strengthens patient safety and builds confidence among stakeholders.
Pathway to Market Entry
A positive review of the MD-12 Test License, combined with the necessary Form-27 submission, among other such requirements, will allow for legal movement toward commercial registration. This sets the regulatory path toward greater market opportunity and more competitive positioning within India's medical device market.
Modification Process
Changes in the testing requirements or device details can be made only to bring the existing MD-12 device manufacturing license into line with what CDSCO expects.
Purpose of Modifying an MD-12 License
Manufacturing companies request modifications if the device features, evaluation needs, or manufacturing details change in the testing phase. Current information helps maintain regulatory clarity and supports accurate assessment of safety and performance under controlled test conditions.
Regulatory Importance of Modifications
A variation request consolidates adherence to the CDSCO norms, as the regularly updated details allow the authorities to verify that the medical device import still complies with the safety and performance standards set out. It prevents the occurrence of regulatory gaps at different stages of test production.
Requirements of Documentation
Revised submissions need to represent updated technical files, corrected testing plans, and refreshed quality documents. Such updates help the reviewers verify each change clearly, ensuring that earlier approved details remain consistent with the new information during the assessment process.
Quality and Safety Considerations
Quality control activities require accurate and up-to-date records. Updated details show how changes affect the device operation, risks, and even assessment processes. Therefore, it is instrumental in maintaining testing that is safe and in accordance with regulatory control.
Impact on Clinical Evaluation
Some modifications update clinical testing plans or evaluation strategies to reflect updated functional requirements. Such changes provide good support for improved performance evaluation and subsequently yield better safety evidence that may later be used in new regulatory applications.
Regulatory Review and Approval
The CDSCO reviews any modification request to ensure clarity, accuracy, and appropriateness. Updated details, including changes linked to GST registration, support a clear regulatory picture and maintain alignment with current requirements. Approval allows manufacturers to study the device further under updated conditions within the existing license structure, according to MD-12, without interrupting ongoing evaluation activities.
Outcome of Modification
Approved amendments support continued testing, and now a clearer route for subsequent applications, like Form 27, is provided. ComplifyXpert offers end-to-end support to the manufacturing company through this process: documentation, submission, and regulatory coordination. Contact ComplifyXpert for smooth guidance at every stage.
Renewal Guidelines
MD-12 does not follow a traditional renewal method. The license remains in force through timely fee payment and updated regulatory documentation submitted through CDSCO's digital platforms and supporting records, such as FDA approval whenever applicable, to demonstrate ongoing compliance.
Retention Approach Instead of Renewal
The manufacturers continue the test license validity of their MD-12 Test License by making payments against the License Retention Fee through the CDSCO MD-Online Portal or the National Single Window System. It keeps the license in active status without issuing any new expiry date.
Documentation Required for Validity
The updated records required to be submitted along with the fee payment are the latest Device Master File, Plant or Site Master File, evidence of the quality management system, and valid supporting certificates. Updated compliance documents serve to meet the alignment of the Medical Device Rules 2017.
Compliance and Regulatory Expectations
All the manufacturers need to follow the Medical Device Rules, 2017 and also any procedural changes resulting from changes in the organisational structure or operational changes. Failure to comply with any timelines and incomplete documentation may lead to the license being suspended.
Importance of Timely Submission
The regular submission via the web portal, together with the payment of the required fee, helps avoid cancellation and processing delays. This structured retention system supports ongoing legal eligibility to manufacture devices for testing and evaluation under MD-12.
Common Rejections
Non-Compliance During Inspections
Rejections are quite common when CDSCO inspectors find lacking conditions that are supposed to be fulfilled before granting a test license. Any mismatch in facility standards, documentation, or quality practices may lead the authority to question the credibility of the application.
Violation of MDR 2017 Requirements
Issues arise when a manufacturer has violated certain provisions under the Medical Device Rules, 2017, and this includes cases linked to IVD kits license obligations. Such a violation leads to a show-cause notice by the authority, in which the applicant is asked to show cause as to why the license should not be suspended or cancelled.
Unsatisfactory Response to Show-Cause Notice
A written explanation regarding each issue raised should be provided by the applicant. If this explanation is incomplete or unclear, then CDSCO may cancel the license with reasons recorded for such cancellation.
Appeal After Rejection
An applicant whose license is cancelled receives the right to appeal before the Central Government within forty-five days of the order. This process provides an opportunity to present additional clarification or supporting documents.
Expert Assistance
1. Smooth Guidance From Start to Finish
ComplifyXpert makes the MD-12 process simple by preparing every file in a clean, clear format. Each detail is aligned for faster CDSCO approval, so your application moves ahead without confusion.
2. Secure Document Handling
All sensitive papers stay protected through a safe digital system. IEC code information is added only when needed, keeping your documents accurate and easy to review.
3. Direct Coordination With Authorities
The interactions with a single point of contact who is committed to handling the communication with CDSCO. The swift replies bring about less waiting time, fewer questions from the reviewer, and thus, your approval cycle remains of the same duration.
4. Clear Requirements, No Worries
All requirements are given in simple terms and you are always aware of the stage of your file. This method helps you to remain at ease and be sure of yourself during the whole period.
5. Fast and Reliable Support
Round-the-clock guidance helps resolve doubts instantly. ComplifyXpert becomes a strong partner for MD-12 licensing, so you can move ahead with confidence and speed.
FAQ
What is the difference between MD-12 and MD-13?
MD-12 allows manufacturing for testing, while MD-13 covers the medical device import of test batches. Both support evaluation, but they each apply to different supply pathways under MDR.
Can I import medical devices with MD-12 license?
No, MD-12 supports only manufacturing test batches. Importance for testing falls under MD-13, which allows the bringing into India of limited quantities for evaluation.
What is validity of MD-12 test license?
Typically, validity is for one year, and during that period, the owner is allowed to carry out test-batch production under the given conditions. Renewal is based on the requirement, correct functioning, and the submission of updated documents in due time.
How much does MD-12 license cost?
The fee structure depends on the class of the device and guidelines by the CDSCO. Companies usually pay for government charges and, additionally, document preparation, technical files, and compliance support.
What is MD-12 test license for medical devices?
MD-12 enables manufacturers to create medical devices solely for the purpose of testing, evaluation, and clinical performance checks or for submissions under MDR 2017, prior to receiving full market approval.
Who needs Form MD-12 CDSCO approval?
MD-12 is an approval required to manufacture in limited quantities legally by manufacturers for research, validation, and compliance assessment prior to commercial launch.
How long does MD-12 license application take?
The time for this is generally 4 to 8 weeks, and however, the processing time is influenced by the correctness of the documents, the standard of the application, the category of the device, and whether any questions are raised in the examination conducted by CDSCO.
What documents are required for MD-12?
Among the common requirements are the particulars of the application, device specifications, QMS information, the testing purpose, the manufacturing layout, the safety data, and an undertaking that confirms that the use is limited to evaluation activities.
How to get MD-12 test license for medical devices?
The application is processed through the portal of CDSCO after the documents are prepared, Form MD-12 is filled, the technical details are attached, the fees are paid, and the response to the review queries is given till the approval is obtained.
