Step-By-Step Process For Medical Device Manufacturing Certification
In recent years, rapid production growth for medical devices has been recognized. The wide range of production brought the revolution in the medical sector. Meanwhile, to regulate the importation, manufacturing, and selling of medical devices, the administration of India introduced the rules and regulations under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.
Registering with CDSCO is necessary for all medical device manufacturers, whether they are active in importation, exportation, or selling. This blog will shed light on which steps to take to register with CDSCO for a medical device manufacturing certificate and how the business can follow the guidelines set by the regulatory body.
What is Meant by a Medical Device License?
As per the guidelines of the Central Drugs Standards Control Organization (CDSCO), to operate the service of medical devices in India, the business is required to obtain a medical device license. The license helps to ensure standard compliance. In India, importers, manufacturers, and operators get the chance to operate their medical device business legally without any non-compliances.
CDSCO provides the medical device certificate. The regulatory body further conducts inspections and tests for safety and quality purposes. By monitoring the work function of medical device manufacturers, the regulatory body protects the patients from potential harm, injury, or infection. Overall, the medical device license is a tool that helps customers understand that the products being provided meet all regulatory requirements and have undergone further testing.
The regulatory body, CDSCO, further monitors that the sellers, distributors, and manufacturers comply with rules and regulations and also must follow the guidelines (e.g., ISO 13485).
Eligibility Criteria to Obtain Medical Device Certification
The registration for medical devices follows a simple procedure; however, businesses need to follow the administrative guidelines before applying for a certificate. For the eligibility, acknowledge the regulatory guidelines of CDSCO. Here are the points to understand what eligibility criteria have been fixed to registering for a medical device license:
1. Meet Compliance Standards
The medical device manufacturing industry is only eligible for the certificate when its products comply with rules and regulations under the Drugs and Cosmetics Act, 1940. The guidelines of the regulatory body involve measurement of the safety and quality grade of the product, including its performance.
2. Legal Entity
The organization or the individual who runs the cosmetic device industry has valid legal rights and obligations. Details of agreements, payments, and the contract of the certificate. Overall, the legal entity refers to an industry that is operating the business under the Indian government’s rules and regulations.
3. Qualified Staff and Facilities
A proper and successful industry demands a qualified and knowledgeable staff that has a further degree in pharmacy or a relevant field of medicine. On the other side, building well-developed and premium-quality machines and equipment increases the chances of obtaining the medical device certificate without delay.
4. Comprehensive Documents
CDSCO demands valid and manageable documents that mention the specifications of medical devices and their test reports. Attaching the documents increases the chances for license approval.
What are the Different Types of Manufacturing Licenses?
The nature and scale of business distinguish the type of medical device license. The regulatory body, the Central Drugs Standards Control Organization one that provides the license to the medical device manufacturing industries. Meanwhile, the regulatory body issues the two types of major licenses for manufacturing industries. Here is the list of medical device licenses:
MD-5: The nature of manufacturing is divided into risk factors. The MD-5 licenses are issued to the Class A and Class B medical device manufacturers. Class A is those that have a minor chance of risk, while the risk chances for Class B are intermediate. The SLA (State Licensing Authority) is responsible to issue license of Class A and B to manufacturers.
MD-9: The steps of regulations and risks determines , the medical device manufacturer certificate are divided into Class C and Class D. The manufacturers who have a large-scale industry also have higher risk chances. In this situation, the state licensing authority doesn’t provide the license, but it is issued by the Central Drugs Standards Control Organization (CDSCO).
The companies that are active in medical device importation, manufacturing, distribution, or selling come in the categories of Class C and D.
Other Licenses: The wholesale license is also obtained by wholesalers, retailers, and stockists. In this category, the businesses stock and distribute the devices in larger quantities. For this license, the applicant is required to fill out the form MD-41.
The Required Documentation for a Medical Device Certificate
As per the guidelines of CDSCO, for the registration for a medical device license, businesses are generally required to submit multiple documents that comply with regulatory requirements. Here is a clearer and more elaborate list description of the required documents:
1. Conformity NOC: This certificate helps the Central Drugs Standards Control Organization to understand that the medical device followed all the standards and requirements under the specified regulations.
2. Plant Master File (PMF): The PMF certificate mentioned that the available medical device company adheres to the quality procedure and builds a strong facility. Furthermore, the certificate clarifies the manufacturing area.
3. Power of Attorney: Attorney power plays the role of legal authorization for an individual. The procedure is operated by an agent or attorney.
4. Form MD-14: It is a type of application form that all medical device manufacturers are required to fulfill and submit on the CDSCO’s official portal.
5. TR6 Challan: As per the Customs Act, 1962,demonstrate the details of the application payment.
6. Form 40: If the manufacturing industry is active in the medical device distribution, it needs to submit Form 40. The form allows the industry to distribute products in India.
7. Device Master File (DMF): The DMF certificate is introduced to mention the information related to technical and other data of devices. The file demonstrates the scale and quality of medical devices.
8. Clinical Test Certificate Report: Attach the report of the device’s clinical performance that allows the official to understand that the device is secure to use.
Process for Obtaining Medical Device Certification
Multi-faceted steps are required to complete the steps for a medical device manufacturing license. In these steps, the businesses or individuals need to collect necessary documents, follow the standard regulations, and many more. Take a look at a comprehensive guide for medical device registration:
1. Collect Essential Documents
It is crucial to gather all the important documentation that makes the application process easier. The documents include PDM files, PMS reports, individual details, information about the industry, and the approval of the relevant authority.
2. An Agent or Consultant
Appointing a medical device consultant or agent decreases the application workload. The consultant guides the manufacturers through a fast process and further defines the required cost for registration.
3. Form Submission
Attach the necessary documentation with the application and submit it on the CDSCO’s official internet portal.
Also Read This – Mistakes To Avoid During Medical Device Manufacturing Certification
4. Inspection for Approval
The firm inspection is a way to monitor and take a view on safety and quality standards. They also make sure that the products meet the requirements of the authority standards.
5. Review or Approval
If the authority obtains the application form with valid documents and other details, they will approve the license. However, if any issues are found in the application form, the authority will raise concerns with reason or reject the application.
The Duration of a Medical Device Manufacturing License
In India, every business license is valid for a fixed period. Before the expiry of the certificate, the manufacturing industries that perform the activities for importation, selling, or distribution are required to renew their medical device certificate. The guidelines of CDSCO declared the 5-year validity of a medical device certificate.
To remain active or continue the medical device work, the business is required to renew the license every five years. Meanwhile, the medical device license holders who provide various certificates include the submission fee for the certificate renewal.
For the renewal of medical device certificates, it is crucial to stay updated with the Central Drugs Standards Control Organization guidelines for the most accurate and current information. Adhere to the new guidelines from the regulatory body for a faster procedure. Check out the documents required for the renewal of the medical device certificate:
- Need for Plant Master File
- ISO 13485 certification
- Required of Device Master File (DMF)
- Declaration of Conformity
- Approval by a Regulatory Authority
- Requirement of Form 40
- Information about technical staff
- Manufacturing license
Final Thoughts
The medical device certificate registration requires a multifaceted procedure. The medical device activities, such as manufacturing, importation, and distribution, are handled by the Central Drugs Standard Control Organization. The accurate testing of medical devices prevents the customers from injury or any harm. For a better understanding, consult with Legal Raasta Pvt Ltd, who are experienced in focusing on transparent communication and providing tailored advice for medical device registration.
