Steps to obtain CDSCO license for Class A and B medical devices.

CDSCO for Medical devices- 5 step process

STEP 1- Establish a Quality management system

The first step is to establish a QMS as per the fifth schedule of the MDR 17 (which is nothing but ISO 13485:2016) by creating the necessary documentation and training people in your organization to maintain the QMS. if you are already using an ISO 13485 QMS then you have most of the things covered. Start-ups will have to establish the QMS from the ground up.

But what is the QMS as per Fifth Schedule?

As the name suggests, a Quality management system is a quality system to manage your organization. it requires you to document all the necessary processes and records related to management responsibility, resource management, product realization (including design and development processes), manufacturing processes and complaint handling, etc. It uses a risk-based approach to ensure the best medical devices are designed and manufactured without any defects.

STEP 2- Create Device Master file as per Fourth schedule of MDR 17

The fourth Schedule Appendix-II of MDR 17 defines the documents required for the Device Master file. these documents are design and development related and require you to show how the device was built and demonstrate the safety and performance of the device through what we call ‘Verification and validation’ Testing of the device. following is a list of what is required:

1.0 Executive Summary: An executive summary shall be provided by the manufacturer and shall contain:

1.1 Introductory descriptive information on the medical device, the intended use and indication for use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier.

1.2 Information regarding sterilization of the device (whether it is sterile or non-sterile; if sterile, mode of sterilization).

1.3 Risk Management Plan, Risk Analysis, evaluation and control documents.

1.4 Clinical Evidence and Evaluation (if applicable).

1.5 Regulatory status of the similar device in India (approved or not approved in India).

1.6 Design Examination Certificate, Declaration of Conformity, Mark of Conformity Certificate, Design Certificate (if applicable). Copy of such certificate(s) shall be enclosed. (TESTING)

1.7 Marketing history of the device from the date of introducing the device in the market.

1.8 Domestic price of the device in the currency followed in the country of origin.

2.0 Device description and product specification, including variants and accessories

3.0 Labelling

4.0 Design and manufacturing information

5.0 Essential principles checklist

6.0 Risk analysis and control summary

7.0 Verification and validation of the medical device.

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates conformity of the device with the Essential Principles that apply to it. It needs to address the elements contained in the Clinical Investigation, as specified under the Seventh Schedule.

STEP 3- Apply for CDSCO License.

Once you have obtained the ISO13485 certification and are ready with documents of fourth and fifth schedule. you will apply for CDSCO license by filling out the form MD-3.

STEP 4- Audit of Manufacturing site

After applying for a license at CDSCO,

CLASS A (sterile or have a measuring function)

Class A devices that are either sterile or have a measuring function will be audited by the Notified body after the state licensing authority grants the license to the manufacturer. this audit shall take place within 120 days of granting of a license by the SLA. the notified body will conduct an audit of the fifth schedule of MDR 17.

CLASS A (other than sterile or measuring)

Class A devices that are neither sterile nor have a measuring function will be given a license based on self-certification which means no audit will be done by any notified body. though the manufacturer of such devices will have to maintain compliance with fourth and fifth schedules of MDR 17.

CLASS B

The audit of the manufacturing site of Class B devices will be carried out within 90 days from the date of application by the registered Notified Body chosen by the state licensing authority which means this audit will be done prior to the grant of license.

STEP 5- Grant of manufacturing license

Once the audit has been done for both the applicable Class A and B devices, the Notified body will submit the audit report to the SLA, and after scrutinizing the audit report the SLA will grant the license within 30 days.

So there you have it, the complete process for Class A and B devices. in case of any doubt please feel free to contact us, we are experts in design and development, creating and implementing the documents required by CDSCO.