The Indian Regulatory Body, Central Drugs Standard Control Organization, commonly known as CDSCO is responsible for the control of drugs and medical devices placed on Indian Market. The government of India has published the medical device rules, 2017, which came into effect from 1st January, 2018.
Under these rules, the manufacturers and importers of devices are required to obtain license which is valid until suspended or cancelled.
Regulatory Authorities for Medical Device Manufacturing License
CDSCO has Central Licensing Authority (CLA) and State Licensing Authority (SLA).
The CLA is responsible for enforcement of Indian Medical Device Rule 2017, relating to:
- Manufacture for Class C and Class D devices
- Import of all classes of devices
- Clinical investigation and approval of investigational medical devices
- clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
- co-ordination with the State Licensing Authorities
The State Licensing Authority will act as competent authority for enforcement of Indian Medical Device Rule 2017 and will be responsible for:
- Manufacture for sale or distribution of Class A or Class B medical devices;
- Sale, stock, exhibit or offer for sale or distribution of medical devices of all classes
The SLA shall assign a Notified body for the assessment of the quality management system and technical documentation for Class A and B Medical Devices. The CLA however may avail the services of Notified body for the assessment of technical documentation for Class C and D medical devices.
Types of Medical Device Manufacturing Licenses
In India, medical device manufacturing licenses are categorized based on the risk classification of the devices. Medical device manufacturing license includes:
License for Class A and B Devices: Granted by the State Licensing Authority (SLA) for low-to-moderate risk devices.
License for Class C and D Devices: Issued by the Central Licensing Authority (CLA) for high-risk devices requiring stricter oversight.
These licenses are essential for ensuring compliance with regulatory standards and safeguarding public health. To obtain a medical device manufacturing license, manufacturers must meet stringent quality and documentation requirements.
California Medical Device Manufacturing License
Obtaining a California Medical Device Manufacturing License is essential for businesses aiming to produce and distribute medical devices in compliance with state and federal regulations. Manufacturers must ensure adherence to quality standards, prepare comprehensive documentation, and meet inspection requirements to secure a medical device manufacturing license and enter the U.S. healthcare market successfully.
CDSCO Medical Device Manufacturing License
The CDSCO Medical Device Manufacturing License is a crucial requirement for manufacturers to ensure compliance with Indian regulatory standards. It guarantees adherence to the Medical Device Rules, 2017, covering quality management, technical documentation, and clinical evaluation. Securing this license enables manufacturers to market devices confidently while meeting safety and performance benchmarks.
FDA Medical Device Manufacturing License
The FDA Medical Device Manufacturing License is crucial for ensuring compliance with U.S. regulations, enabling manufacturers to produce and distribute devices in the U.S. market. This license requires adherence to FDA guidelines, including Good Manufacturing Practices (GMP) and Quality System Regulations (QSR). Obtaining an FDA medical device manufacturing license ensures product safety, efficacy, and regulatory approval.
License for Surgical Bandage Manufacturing
To obtain a license for surgical bandage manufacturing in India, manufacturers must adhere to the Medical Device Rules, 2017, and ensure compliance with Quality Management System requirements. Proper documentation, including a Device Master File and Plant Master File, is crucial. The license required for surgical bandage manufacturing falls under Class A or B, depending on the risk classification.
How to Register for CDSCO Manufacturing License?
To register for a CDSCO manufacturing license, medical device manufacturers must create an account on the SUGAM Portal, submit required documents, and ensure compliance with the Indian Medical Device Rules, 2017. Proper documentation, including a Plant Master File and Device Master File, is critical to obtaining the medical device manufacturer license efficiently.
