Steps to obtain CDSCO license for Class C and D 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 are ready with documents of fourth and fifth schedules. you will apply for CDSCO license by filling out the form MD-7 for class C and MD-8 for Class D and uploading the technical documents on CDSCO portal. The scrutiny of application will be completed by the Central Licensing Authority within a period of 45 days from the date of online submission of application.
STEP 4- Audit/Inspection of Manufacturing site
After the scrutiny of application, the manufacturing site for both Class C & D devices will be inspected within a period of 60 days from the date of application by a team comprising not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert, or a Notified Body.
STEP 5- Grant of manufacturing license
After completion of inspection, the inspection team will forward a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central Licensing Authority, through online portal of the: Ministry of Health and Family Welfare in the Central Government and forward a copy of the same to the applicant.
If the Central Licensing Authority, after receipt of the report is satisfied that the requirements of these rules have been complied, that Authority shall grant a licence in Form MD-9, or may reject the application for reasons to be recorded in writing, within a period of forty-five days from the date the inspection report has been received.
IN CASE OF REJECTION:
If the application for grant of licence is rejected , the aggrieved person may file an appeal before the Central Government(CDSCO) within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days.
So there you have it, the complete process for Class C and D 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.
