CDSCO Form 27 is majorly used to register medical devices in India. For those manufacturers wanting to sell their medical devices to the Indian market, it is an essential form. All these medical devices ensure they meet law-defined safety and efficacy standards to allow commercial distribution.

CDSCO Form 27 and the CDSCO MD-12 Test License

The CDSCO takes care of regulations regarding medical devices in India through basic tools such as CDSCO Form 27 and MD-12 Test License. Form 27 is taken into account for the registration of medical devices under the Medical Device Rules, 2017, which demands comprehensive details of the device's intended application, design, and manufacturing process to guarantee safety and quality.

In contrast, the MD-12 Test License allows manufacturers to manufacture a few units of their medical devices for clinical use and testing. This license is essential in assessing the performance and safety of the devices before they hit the market. All these regulatory mechanisms combine to promote public health and safety with innovation in the medical device sector.

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Importance of CDSCO Form 27 and CDSCO MD-12 Test License

CDSCO, Form 27 accompanied by CDSCO MD-12 Test License, forms the most critical regulatory requirement for the production of medical devices in India. The following are key points regarding its significance:

• Regulatory Compliance: Both Form 27 and the MD-12 Test License ensure that such healthcare products meet the set CDSCO regulations for providing safety and efficacy.
• Facilitates Clinical Trials: An MD-12 Test License allows manufacturers to produce devices for clinical testing and evaluation, which is necessary for safety and performance validation before market launch.
• Quality Control: Form 27 demands records of documentation with quality management systems to ensure only good quality medical devices are registered and marketed.
• Risk Mitigation: Strict regulatory requirements are enforced through these tools and therefore reduce the risk posed by unsafe or ineffective medical devices. This would consequently promote the health of the public.
• Market Access: A successful registration through Form 27 and achievement of the MD-12 Test License permit legal marketing of the devices in India, thereby improving competitiveness in the healthcare sector.

Key Features of Form 27

Mandatory Registration: Form 27 is essential for registering medical devices, ensuring compliance with the Medical Device Rules, 2017.

Types of Devices: The form covers several classes of medical devices, which are classified depending on the risk levels:

• Class A: Low risk
• Class B: Low moderate risk
• Class C: Moderate high risk
• Class D: High risk

Supporting Documents: Applicants must submit essential documents, including clinical evaluation reports and quality management system certifications, alongside Form 27.

Market Access: Successful registration through Form 27 allows manufacturers to legally market their medical devices in India, promoting safety and efficacy.

Key Features of MD-12 Test License

• Purposes: The MD-12 Test License offers an opportunity for the manufacturers to develop those medical devices, which would be used strictly under non-commercial conditions.
• Field of Use: The devices developed on this license can be used in clinical trials or studies to test the safety and efficacy of that device before it hits the market.
• Approval: It is important to get an MD-12 Test License because it ensures fulfillment of all the regulatory requirements issued by CDSCO under the Medical Device Rules.
• Non-Commercial Use: Permits production solely for testing purposes, prohibiting any commercial sale of the devices manufactured under this license.

Read Our Blog: CDSCO Test License for Medical Devices

Application Process for MD-12 Test License

The application process for obtaining an MD-12 Test License includes:

• Online Registration: Manufacturers must first register on the CDSCO's Sugam portal to create an account for submitting applications.
• Application: The applicants fill up Form MD-12, which requires them to provide all the details about the medical device to be tested - the intended use and the specifications for the device.
• Uploading Supporting Documents: The respective form is to be accompanied by uploading supporting documents including certifications under Quality Management Systems etc.
• Paying Applicable Fees: The fees applicable for the license to test have to be paid along with the application.
• Scrutiny and Issuance: CDSCO will, on receipt, scan the application and documents. Once apparently in order, it will issue the Test License to enable restricted manufacture for testing.

Validity and Cancellation of Licenses

MD-12 Test Licenses and Form 27 registrations are registered for the following period:

• MD-12 Test License: The license shall be valid for three years from the date of the license.
• If a licensee fails to comply with the provisions of regulations or violates such provisions, then he will receive a show-cause notice by CDSCO that may result in the cancellation of his license.

Conclusion

Both the CDSCO Form 27 and the MD-12 Test License are vital in the regulatory structure put up in India about medical devices. As the form makes possible the registration process required in commercial distribution, the MD-12 Test License makes it feasible for manufacturers to manufacture a device strictly for testing. Knowing such forms and their corresponding methods in the value chain provides the way toward strict compliance with Indian regulations for medical devices to ensure that the products marketed are safe and effective for public use.

These regulatory requirements, therefore, have increased the peace of mind of manufacturers not only in terms of legal compliance but also in terms of enhancing patient safety and ensuring better care in India.