Are you looking to produce medical equipment in India? Then this will help you recognize CDSCO requirements first and, next, gather the essential documents, which are item specifications, facility plans, and business registration. Finish the CDSCO application and compile everything to be reviewed. Make sure that the medical device rules and ISO 13485 are followed. Get your manufacturing license for medical devices after passing the inspection for continuing manufacturing legality; keep it updated. Phew, these are the things you need to follow, and voila, you’ll get your License.

Regulatory Bodies of CDSCO

The Central Drug Control Organization (CDSCO) is the entity to deal with if you are thinking of producing medical devices in India. They are the principal regulatory agency in charge of this operation. To get your manufacturing license, you can take the following actions. Recognize the requirements set out with CDSCO, collect the needed documents, including details of your firm registration, and get everything ready for the inspection. Ensures that you follow the safety and quality standards, including ISO 13485. CDSCO will issue your manufacturing license once your facility has cleared the inspection. Renew it on a regular basis, as this will help you stay in compliance.

Medical Device Categorization According to Risk Factor

Risk factor classification plays a very crucial role in terms of medical devices. It helps in guaranteeing these devices’ efficiency and safety. In short, the risk posed by medical equipment to patients is considered while classifying them into various groups. Tongue depressors and bandages are examples of low-risk class 1 devices. Adhesives and other devices came under class II devices which shows they show moderate risk. Pacemakers and implantable defibrillators are examples of class III high-risk devices. Knowing how medical devices are categorized enables producers and authorities to make sure the right steps are followed to ensure their safety and effectiveness. 

Documents Required For Manufacturing License For Medical Devices Registration

Here is the simplified list, look below as it is mentioned there:-

• TR6 Challan
• Power Of Attorney
• Application Form
• CE Design Certificate
• Declaration Of Conformity
• Schedule D (1)
• Master File Of Device
• Master Report Of Plant
• Certificate Of Free Sale
• Quality Assurance Certificate

What Is The Procedure To Get Manufacturing License For Medical Devices?

Prior to manufacturing medical devices, research must be done and rules such as FDA guidelines must be followed. Form a formal organization and secure the required permits. Provide a quality management system (QMS) that guarantees effectiveness and safety. Create and test devices while following Good Manufacturing Practices (GMP). Before going on sale, test and verify the equipment. To ensure safety and comply with regulations, keep accurate records.

What Is The Validity Period of Manufacturing Medical Device?

Five Years is the validity period of the manufacturing license for medical devices. Instance if the manufacturing license of medical devices was not suspended or cancelled. Candidates can apply under 45 days from the target date.

Conclusion

In conclusion, rigorous adherence to ISO 13485 standards and CDSCO requirements is necessary to get an Indian manufacturing license for medical devices. Safety measures are guided by risk factor categorization. Registration requires certain documents, such as a TR6 Challan and a Power of Attorney. The license has a five-year validity period, subject to renewal and compliance. Obtaining import and production permissions, as well as an IEC code, is necessary to begin manufacturing medical equipment in India. The CDSCO-mandated Form MD-1 provides information on the company and its adherence to quality management. By taking these precautions, medical device manufacture in India is guaranteed to be both legal and high-quality.

Frequently Asked Questions