Mistakes To Avoid During Medical Device Manufacturing Certification
In the medical field, medical devices are the major tools. While in Asia, India stands on 4th position globally for being the highest producer of medical devices. In the past few years, rapid growth has been recognized in the medical device manufacturing industry. With the increase in medical device production, the safety standard process is also exceeding.
However, to obtain the certificate, it is mandatory to provide valid information according to requirements. However, the barrier of mistakes can be reduced by following the guidelines of the Medical Devices Rules, 2017. Let’s explore what mistakes should be avoided during the medical device certification process.
Use of a Medical Device License in the medical Industry
Before providing the medical device license, the tool undergoes clinical trials and other major tests that ensure the efficacy and safety standards. The medical device businesses register with the CDSCO to connect legally. The valid license gives the assurance that the tool is safe for further use in the market. In addition, the certificate helps to operate the importation, distribution, and manufacturing.
In India, the medical device license works as a regulatory framework. The medical device manufacturing certifications are introduced to give proof of safety and quality standards. In addition, licenses are provided by the two types of authorities, depending on the nature of the device.
As per the rules and regulations, the Class A and B devices, a medical certificate issued by the State Licensing Authority. On the other side, the Central Licensing Authority is responsible for issuing the certificate for Class C and D devices.
Types of Medical Device Licenses in India
Manufacturing License: The medical device businesses that engage in production or manufacturing activity need to register for a manufacturing license. The manufacturing certificate is provided by the CDSCO or the State Licensing Authority in India. In India, the CDSCO is the only authority that accurately assesses the efficacy of drugs, cosmetics, and medical devices.
Import License: In India, the medical device importers need to register for an import license with the CDSCO. Whether they are distributors, research institutions, wholesalers, etc., they need a CDSCO medical device import certificate. The use of a license is to monitor compliance with Indian rules for safety and quality purposes.
Test License (MD-13): The Form MD-13 is provided by the CDSCO for the minor quantities of Class A, Class B, Class C, or Class D. With this license, the medical device can be used for testing, training, or clinical research. The certificate allows the operator to produce the device in limited quantities. Small firms that manufactured the device for the purpose of testing or training, register for the Medical Device Test License (MD-13).
Loan License: The medical device manufacturers who are interested in working with another company to utilize the facilities for production need to register for a loan license. The loan certificate is similar to the manufacturing of Class A and B devices. The devices are obtained by the individual from the other organization but maintain the safety and quality standards.
Reason Behind Rejection of a Medical Device Certification
The absence of valid documents and details can lead to rejection for a medical device certificate. In some cases, the industry failed to meet the required standards of the regulatory body, which also caused the certificate to be canceled. The mistakes can be eliminated by avoiding them with proper documents.
Meanwhile, the major mistakes created during the medical device manufacturing certification are providing personal details, hiding the real nature of resources, not following the guidelines of the regulatory body, and failing to show the true documents. During the application process, the Central Drugs Standard Control Organization demands valid documents that meet the requirements for a license.
Classification of Errors in Medical Device License with its Solutions
1. Schedules and Resource Maintenance
Improper management of the resources is the primary mistake made by the medical device industry. Fixing the unrealistic timelines and operating the project underfunded leads to various risks.
However, the mistakes can be solved by allocating significant time and conducting thorough risk assessments. Providing significant time to the tools’ productions and rushed projects can also lead to critical testing.
2. Human Factors
Underestimating the impact of human factors is a common mistake made during medical device production. Without testing the quality standards of the tools, you can cause harm to the patients and lead to safety risks and errors.
The mistake can be eliminated by listing the human factor during the development of the device and conducting mandatory testing before use on consumers.
3. Regulatory Classification
Providing the correct details is the first step to registering with CDSCO. However, if someone fails to provide the classification according to the requirements, they can suffer from license delay or even medical device certificate rejection.
Following the provided regulations, enhance understanding the level regarding the medical device license.
1. Requirement Definition
Performance and functionality are the major features to ensure the safety of the device. If the industry fails to prove the safety requirement, it can face rejection. Build a concise and clear document that defines the quality of the device. The clear and measurable documents eliminate mistakes during the certification.
2. Controls and Documentation
In several cases, the medical device industry fails to follow the key document procedures, including non-conformance handling. The mistake increases the risk of delays during audits. The issue can be avoided by understanding the documentation procedure.
3. Biocompatibility Testing
Submitting the medical devices without the biocompatibility test can cause the rejection of the pharmaceutical license. The medical device business operator needs to submit the correct reports that showcase the accuracy of the devices’ materials’ performance and safety.
Documents for Medical Device License to Avoid Error
The correct required documentation decreases the risk factors during medical device manufacturing certification. It further eliminates the issue of rejection. CDSCO sets guidelines that are followed by its regulatory body to ensure safety and quality parameters. Meanwhile, here is the list of documents to avoid mistakes during the license application.
1. Visible details of products with a clear logo
2. ISO 13485 certificate.
3. Requirement of Certificate of Analysis (COA)
4. Declaration of Conformity (DOC)
5. Need for DMF (Design Master File) and Plant Master File (PMF)
6. Free Sale Certificate
7. Cover letter
8. Authorization letter
Things to Consider While Doing Medical Device Registration
- The issue of errors during the medical device licensing process can be minimized with clear and concise documents, complete and truthful information about the business, and a management process plan.
- Avoid using multiple languages during the application process, and recheck all documents.
- Maintain the format of documents like labels, records, and signatures.
- To eliminate delays or rejection, make sure you have the necessary details.
- Structured a system for device testing twice in all critical situations. Further, label whether the equipment is well-maintained for use or not.
- Label the concise and clear instructions of the tool for the purpose of use and operation in the medical field.
- Ensure whether the equipment is damaged or not before presenting it in the market for medical use.
- Work with knowledgeable staff to reduce mistakes. Conduct the training session regarding the billing, documentation, and coding process.
How does a Regulatory Body Check Validation Standards?
1. In India, the Central Drugs Standards Control Organization (CDSCO) performs as a regulatory body for medical devices. The working process of the regulatory body is similar to that of the FDA of the UK.
2. While in India, CDSCO is responsible for checking or providing the accuracy of medical device licenses. Under the Medical Devices Rules, 2017, ISO 13485, and CE Directive 93/42/EEC, the efficacy and safety standards of medical devices.
3. As per the CDSCO guidelines, the medical device license certification needs a Plant Master File (PMF), which gives access to the manufacturing facility.
4. The regulatory body re-checks the application to ensure compliance with the terms and conditions. The site inspection is also part of the medical device certificate process.
5. CDSCO demands a medical device testing certificate and validation list, which gives proof that the device is suitable for use. It is required that the main characteristics of the device be examined during the production and manufacturing processes.
6. After the approval of the medical device certificate, the officials of CDSCO monitor the activities of the industry, such as manufacturing, testing, importing, and many more.
Final Thoughts
Whether an operator is experienced or building a new medical device industry, they need to follow the guidelines of the CDSCO. It creates an easy path to obtain medical device manufacturing certification without delay or suspension. The team of Legal Raasta supports the various medical industries by guiding and offering knowledge on licensing, including the process to decrease complexity during license registration. Receive consultation from our experts to eliminate the risk of fines and penalties with proper documentation.
