An NSNM compliance audit can prove to be difficult for low-risk medical device manufacturers if they lack knowledge of the processes. A smooth NSNM medical device compliance audit keeps your team compliant with all CDSCO regulations and stays prepared for audits in India, and remains secure and legally compliant.
You will learn step by step and not make errors. This will ensure you pass your audit with ease and save time.
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Non-Sterile, Non-Measuring Medical Devices
NSNM medical devices are those that don’t need to be sterilized and do not measure any parameter like blood pressure or body temperature. These kinds of devices usually fall under Class A by CDSCO guidelines, such as adhesive bandages or thermometers that just measure body temperature and don’t actually measure it.
Since such devices fall under low-risk devices, it is not necessary to undergo proper testing and certification processes like those required for higher-risk devices. This also does not mean that manufacturers are exempt from necessary compliance processes.
For Indian companies or importers, registration of such devices on CDSCO’s SUGAM portal is a mandatory process. Many choose to rely on expert NSNM Medical Device Registration services to avoid mistakes and speed up the process.
Documentation is necessary as well, and skipping these simple processes can lead to your application being rejected or facing regulatory issues in the future. Failure to comply may also result in delays in product launch and legal penalties. You have understood what NSNM medical is, so now let’s see the NSNM audit tips in detail.
Tips to Conduct NSNM Medical Device Audits
An effective NSNM medical device audit India is a detailed step-by-step approach. These are some of the major tips that can help you with your internal audits and prepare you for an external CDSCO audit.
1. Prepare and Plan for an Internal Audit
One of the initial things to do in getting ready for an NSNM compliance audit is an internal audit. Begin by checking your company’s registration papers, device information, and packaging information.
If your company imports or manufactures devices, these devices come under the category of NSNM and comply with the CDSCO-established minimum quality and safety requirements.
Your internal audit must include verifying the product registration number on the SUGAM portal to ensure the device is registered in the correct category.
The self-certification of quality and safety has been completed and submitted according to the prescribed protocol. Check if the device labels and packagings are also as per the CDSCO norms. Finally, keep clear records of every check so you can fix any gaps before the official audit begins.
2. Enforce Corrective Actions in Compliance Audits
Being an internal audit activity, it is only natural that you can identify areas of non-conformity. For instance, you can observe that some batches of the devices have no documentation or incomplete traceability records.
These need to be rectified before the official CDSCO compliance audit. Corrective action must be taken. Develop a corrective action plan for each non-conformity you find.
From labeling errors, insufficient product information, to missing batch records, the fix must be prompt and documented. The sooner you correct these, the less trouble it will cause when your documents are examined by the CDSCO officer.
3. Start Training Programs
Effective training programs for your staff are crucial for a smooth medical device audit. Your team should understand the importance of regulatory compliance and the processes they need to follow to meet CDSCO standards.
Develop a training schedule and ensure all employees, especially those involved in production, quality control, and documentation, are aware of the audit expectations. They should know how to correctly document and explain all stages of manufacturing, product testing, quality control, and shipment.
4. Documentation for Effective Risk Management
Effective documentation is one of the important things of a successful NSNM compliance audit. Every action taken during the device’s lifecycle should be documented, from design and manufacturing to packaging and sale.
This includes keeping a master file for each device, which should contain detailed information about the product, production process, risk management procedures, quality checks, and labeling. While NSNM devices do not require ISO 13485 certification, having a clear quality management system in place is still necessary.
Your device master file should cover all aspects of production and compliance. In addition, a risk management plan should be in place to track and address any safety or performance concerns that arise after the device is sold in the market.
5. Ensure Quality Management System
Though ISO 13485 is not mandatory for NSNM devices, your company still needs to maintain a simple but effective quality management system (QMS). This QMS should be the best practice industry standard and regulatory compliant. The QMS should include quality control steps, such as inspection procedures, batch control systems, and clear labeling protocols.
An effective QMS helps ensure that your devices meet safety and performance standards throughout their lifecycle. This also allows you to have clear evidence of compliance when undergoing a CDSCO-compliant audit or any other medical device regulatory audit in India.
To Conclude
Successfully passing an NSNM medical device compliance audit requires careful preparation and attention to detail. By following the tips outlined above, including conducting internal audits, implementing corrective actions, and ensuring that all documentation is in order, your company will be well-prepared for a CDSCO compliance audit.
Make sure that your team is trained, your quality management system is strong, and that you are following all major regulatory requirements to guarantee a smooth process. This will not only help you pass your audit but also ensure that your devices meet Indian device safety audit standards, providing confidence to your customers and regulators alike.
