The Central Drugs Standard Control Organization of India regulates medical devices, ensuring that all such medical devices meet the established standards of safety and efficacy. Among many requirements from regulation, the most relevant one for manufacturers looking forward to producing medical devices intended for testing, evaluation, demonstration, or training purposes is to obtain a “Test License”

Understanding the CDSCO Test License

CDSCO Test License is a license that would permit the manufacturers to make production of a limited quantity of Medical Devices falling within Class A, Class B, Class C, or Class D for purposes of Clinical Research, Evaluation, Demonstration, Training, and so on. And, this is in itself a necessity for the testing safety and efficacy of such devices before the same could be put for commercial usage.

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Significance of CDSCO Test License:

• Adherence to Regulations: A test license ensures adherence by the manufacturers to the MDR 2017 and other relevant regulations.
• Safety Measures: It helps ensure that devices made for medical purposes are tested to ensure their safety and success before reaching the market.
• Preparedness at the Commercial Level: Obtaining a test license allows manufacturers to get essential information regarding the manufactured devices and gets them ready for commercial acceptance.

Categories of Medical Devices    

CDSCO classifies medical devices into four classes based on the risk associated with them. These categories are as follows:

• Class A: Low-risk devices (bandages, surgical gloves, etc.).
• Class B: Low-to-moderate risk devices (blood pressure monitors, etc.).
• Class C: Moderate-to-high-risk devices (catheters, etc.).
• Class D: High-risk devices (pacemakers, etc.).

The intensity of scrutiny in the licensing process depends on the class of the device.

How to Obtain a CDSCO Test License for Medical Device

Step 1: Registration on the Sugam Portal

The manufacturers should first register on the “Sugam portal”, an official online portal through which they submit their applications for a medical device.

Step 2: Application Preparation

The manufacturer has to make an application through “Form MD-12”. Among the essentials that are incorporated in the application are:

• A concise description of the medical device, the use for which the medical device has been designed, and the material construction of the same.
• The rationale behind the suggested number of devices that the manufacturer wants to manufacture.
• Test protocols or approved clinical investigation plans.
• Quality management system (QMS) certificates.
• Labels and Instructions for Use (IFU).
• Declaration that the device will be used for non-commercial purposes.
• Confirmation from testing laboratories regarding available facilities.

Step 3: Uploading Required Documents

All the mandatory documents as mentioned in the MD-12 checklist should be uploaded along with the application on the Sugam portal.

Step 4: Payment of Fees

Manufacturers are liable to pay a government fee while applying as given below:

• For a test license for manufacturing: ₹500 for each different type of medical device.
• For a test license for import: USD 100 for every different type of medical device.

Step 5: Application Submission

All the sections of the form are duly filled up, all the documents are arranged properly, and the application can be submitted by manufacturers via the Sugam portal.

Step 6: Review Procedure

CDSCO will process the application when received. If the information is deemed insufficient, CDSCO could send a deficiency letter asking for further clarification or detailed documentation.

Step 7: Issue Test License

After being cleared by the regulatory, CDSCO shall issue the Test License in Form MD-13 for the testing and evaluation of the activity by the manufacturer.

Read Our Blog: CDSCO SUGAM Registration For Online Application

Validity and Renewal of CDSCO Test License

The validity period of the CDSCO Test License is “three years” from the issue date. In this, manufacturers would have to follow any additional requirements placed inside of it by law throughout all of these years. Should more time be considered by such a company for another batch then further tests and analysis on the product necessitate renewed application by such manufacturing unit before the near end period of the former submission made.

Challenges Facing Manufacturers in Obtaining CDSCO Test Licence

• Detailed Documentation: Preparing detailed documentation is time- and resource-consuming.
• Lack of Clear Requirements: The requirements that pertain to classes of medical devices are not clearly defined
• Extended Application Periods: Long extended periods for the review processes due to a large volume of applications or a demand for more information.

Future Developments in the Regulation of Medical Devices

As new types of medical devices and emerging technologies are developed, there is likely to be refinement in the regulatory framework for CDSCO:

• Strengthening Regulation: As awareness of safety concerns continues to grow, there could be an overall trend toward increased regulation over previously non-notified categories.
• New Technologies: The advent of digital health solutions and other new technologies might require new classification frameworks for addressing risks in ways that are not previously encountered.
• Stakeholder Engagement: Ongoing dialogue between regulators and industry stakeholders will be essential to adapt regulations effectively.

Conclusion

The CDSCO Test License is an important part of ensuring that medical devices are safe and effective before they hit the consumer market. If manufacturers follow the process described above and understand regulatory requirements, they can better navigate this complex landscape.

Being up-to-date with the changes and liaising with relevant authorities will be vital to the success of compliance and access to the market in India as it continues to strengthen its regulatory framework for medical devices. Effective regulatory processes not only safeguard public health but also spur innovation within the medical device industry.