CDSCO Medical Device Registration for Dialysis Machine - Process, Documents required, Fee
CDSCO refers to the Central Drugs Standard Control Organisation being India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
The Indian Government has announced its plan to bring all Medical Devices including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.
What is a Dialysis Machine as a Medical Device under CDSCO?
The Dialysis Machine mixes and monitors the Dialysate. Dialysate refers to the fluid which helps to remove unwanted products from the blood. It also helps electrolytes and minerals to reach their proper levels in the body.
A Dialysis Machine is a Medical Device that filters out extra waste and fluid from the body. It also regulates the blood pressure and the blood flow in the body.
What is CDSCO Medical Device Registration for Dialysis Machine?
CDSCO Medical Device Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
The selection of applications varies according to the device type, applicant characteristics, operations and home country approval. The CDSCO grants license for device testing, import or manufacturing after carefully evaluating each application.
Importance of Medical Device CDSCO registration for Dialysis Machine
Importance of CDSCO Medical Device Registration for Dialysis Machine can be studied as follows:
- Safety & Quality of Products: CDSCO registration ensures that cosmetic products don’t include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
- Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
- Unlock Market Access: CDSCO Registration is required before dealing with Drugs, Medical Device, and Cosmetic Products. It makes sure that they are free of heavy metals and other toxins for being safe to be consumed by the masses. CDSCO provides new opportunities in the Market.
CDSCO Fee for Product
The Professional Fee For CDSCO Medical Device Registration for Dialysis Machine is INR 99,999/- only with Monitrix.
| Note: The aforementioned Fees is exclusive of GST. |
Documents required in the CDSCO Medical Device registration for Dialysis Machine
Following are the important documents required in the CDSCO Medical Device Registration;
- Form 40
- ISO 13485 Certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all details provided are authentic
- Free Sale Certificate or Certificate from the Foreign Government
- Plant Master Report
- Device Master File
Conclusion
CDSCO Registration for Dialysis Machine as a Medical Device is a mandatory step to be done as the Indian government has announced its plan to bring all medical devices including implants and contraceptives under a review of CDSCO. The application for registration certificate or import license can be made to the Licensing authority at CDSCO.
Why Monitrix
At Monitrix, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
