Medical Device Test License: Empowering Medical Device Manufacturers in India with Cutting-Edge Testing Capabilities
In India, all Medical Devices are regulated by the Medical Device Rule, 2017. The rule provides provisions for manufacturers to manufacture small quantities of Medical Devices for the purpose of Clinical Investigations, Tests, Evaluations, Examinations, Demonstrations, or Training. This license is known as the Medical Device Test License MD-13.
The MD-13 license is a valuable resource for medical device manufacturers in India. It allows manufacturers to develop and assess medical devices in controlled settings, which promotes innovation, quality assurance, and advancements in healthcare.
The MD-13 license helps manufacturers to obtain feedback on the performance of their devices and to demonstrate the safety and efficacy of their devices to regulatory authorities. This can lead to the improvement of medical devices and patient care in India.
- Allows manufacturers to develop and assess medical devices in controlled settings.
- Promotes innovation, quality assurance, and advancements in healthcare.
- Helps manufacturers to obtain feedback on the performance of their devices.
- Demonstrates the safety and efficacy of medical devices to regulatory authorities.
- Can lead to the improvement of medical devices and patient care.
If you are a medical device manufacturer in India, the MD-13 license is a valuable tool that you should consider obtaining. It can help you to improve the quality of your products and to ensure that they are safe and effective for patients.
Form MD-12 is an application form for a Medical Device Test License-MD-13 in India. The MD-13 license is issued by the Central Drugs Standard Control Organization (CDSCO) to manufacturers who want to manufacture small quantities of medical devices for the purpose of clinical investigations, tests, evaluations, examinations, demonstrations, or training.
Licensing Authority
Central Drugs Standard Control Organization (CDSCO) is the Licensing authority for the grant of Medical Device Test License MD-13 in India.
- Use of the license: The licensee shall use the license exclusively for clinical investigations, tests, evaluations, examinations, demonstrations, or training at the place specified in the license.
- Access to premises: The licensee shall allow the Medical Device Officer to enter the premises with or without notice to satisfy himself that only clinical investigations, tests, evaluations, examinations, demonstrations, or training are being conducted.
- Recordkeeping: The licensee shall maintain a record of the quantity of medical devices manufactured, tested, and stocked and their disposition.
Documents Required to Get Medical Device Test License MD-13
- Covering Letter
- Brief description of the medical device including intended use, the material of construction, and design.
- Undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices.
- List of equipment and instruments.
- List of qualified personnel
- Justification of quantity proposed to be manufactured.
- Test protocol, if any
- Quality Management Certificates like ISO 13485, ISO 9001 of the manufacturer from where the raw material is to be procured, if any
- Copy of manufacturing license, if any
- Approval letter authorizing to undertake research and development activities issued by any government organization, if any
- Schematic Plan of Premises
- ISO 13485 Certificate of the manufacturing site
- Detailed description of how the raw material will be procured
- Receipt of fees
The process to Get Medical Device Test License MD-13
- The applicant should fill out the application form MD-12 on the online CDSCO Sugam Portal.
- Upload all the required documents.
- Pay the prescribed fee
- Submit the Application to the Licensing Authority.
- After scrutiny of documents, if found satisfactory, the CDSCO shall grant the registration certificate in Form MD-13.
Fees of the CDSCO Test License MD-13
The applicant has to pay ₹ 500/- for each distinct Medical Device for the test license MD-42.
Validity of the CDSCO Test License MD-13
The Medical Device Test License shall remain in force for a period of three years from the date of its issuance. The license can be canceled earlier if there are any violations of the rules.
Conclusion
The Medical Device Test License-MD-13 is a valuable tool for medical device manufacturers in India. It can help you to improve the quality of your products and to ensure that they are safe and effective for patients.
If you are interested in obtaining an MD-13 license and need any further assistance and guidance to get the MD-13 license, please contact our 24-Hour Customer Support No. +91-7807-91-4459. You can also WhatsApp your query to +91-7807-91-4459 or email us at [email protected] or you may visit our official website.
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