Medical device manufacturers must have a crystal-clear record of activity. If your medical devices malfunction, the consequences on the lives of innocent people are disastrous. This is why obtaining a non-conviction certificate is crucial.
This certificate verifies that you have not been convicted of any mishaps related to substandard quality of devices. As a result, it is proof of your regulatory compliance. In this post, we’ll explain what is a non-conviction certificate in detail.
What Is a Non-Conviction Certificate?
The non-conviction certificate certifies that you have a valid medical device license and have not been convicted under the Medical Devices Rules 2017 for the following reasons:
- Deaths or injuries related to your medical devices.
- Reported malfunctions or quality standard violations.
- Instances of your devices violating the quality standards.
The non-conviction certificate is issued by the respective licensing authority, which has issued the manufacturing license for a particular device. After you receive the certificate, its validity is for one year.
What Is the Use of a Non-Conviction Certificate?
Tenders and procurement processes in India and international markets require a non-conviction certificate. It shows that your medical device company is fully compliant. In addition, the certificate indicates that you are successful in manufacturing medical devices that meet regulatory standards. It is essential for maintaining market integrity. The NCC also enhances your market reputation, which allows potential clients and partners to view your services in a positive light.
Who Can Apply for a Non-Conviction Certificate – Eligibility Criteria
The application process for NCC is open to Indian companies with a valid medical device manufacturing and/or import license. Also, you should not have any track record of getting caught in an offense related to the quality and performance of your devices under the Medical Devices Rules 2017.
How Do You Obtain Non-Conviction Certificate – Application Process?
The application and approval of NCC follow three major steps, which include document collection, application submission, and review by the licensing authority.
1. Document Collection
To apply for the NCC, you need a couple of documents. These include:
- A covering letter addressed to the State Licensing Authority (SLA) or Central Licensing Authority (CLA). The cover letter should include the intent of the application and mention the documents you are submitting.
- A list of devices that require NCC.
- Authorization of the signatory of the form.
- A copy of your licenses or renewal certificate held and retention certificate wherever applicable.
- A signed legal declaration on a Rs. 100 notarized stamp paper stating that no legal action has been taken against the firm.
- A prior NCC, if applicable.
2. Application Submission
Find the application form for the non-conviction certificate on the www.cdscomdonline.gov.in website. Use this link to access the form and fill it out. After that, attach the relevant documents and submit the application to the Authorities.
3. Review and Issuance
Your application is reviewed by the designated licensing authority. If they do not find any convictions, an NCC is issued. It will be valid for a year from the date of issuance.
How Long Does It Take to Get a Non-Conviction Certificate from Licensing Authorities?
The process of obtaining an NCC from Licensing Authorities usually takes a few weeks. The licensing authority can take up to 15 days to review the process. This period varied according to the workload on the authority.
After checking and analyzing your application, the licensing authority issues the NCC within a few weeks. So, overall, you may need to wait for four weeks to get NCC.
What Happens If Your Application for a Non-Conviction Certificate Is Rejected?
You must understand the reasons for the licensing authority’s rejection of your NCC application and take the necessary steps. Usually, the rejection happens because of the following reasons:
- Submission of invalid documents.
- A violation of rules related to medical device manufacturing negatively impacts your application’s status.
You can find the status of your application by logging into the medical device sugam portal. Click Menu, followed by Form Submission, and then submit applications. If you find your application here, it means you need to rectify the issues with it. This is why working with experienced CDSCO or FDA registration consultants is crucial. It enables you to navigate the complexities in document preparation, submission, and getting approval.
Specific Offenses Related to Medical Devices That Are Considered When Issuing the NCC?
Before applying for NCC, you must know the compliance laws related to medical devices. It will increase your chances of application approval. According to CDSCO, the following regulations are critical for medical device manufacturing in India.
- The medical device should conform to the standards of the Bureau of Indian Standards set up by the Bureau of Indian Standards Act, 1985.
- If no relevant standards are specified, the medical device should be compliant with the International Organisation for Standardisation (ISO) or the standards set by a validated manufacturer.
- Manufacturing counterfeit and mislabelled devices are strictly prohibited.
You can find detailed guidelines for medical devices by the BIS here.
Concluding Words:
A valid Non-Conviction Certificate for manufacturers and medical device importers shows their commitment to safety and compliance. It strengthens your reputation in the market and boosts trust in your services. If you want to speed up the process of getting this certificate, working with trusted medical device registration consultants is crucial.
They streamline your application process and provide support throughout until you receive the certificate. Contact Dueran Consultant today for a free consultation on obtaining an NCC.