Posted by The medical device market in India has been witnessing significant growth in recent years. It is because of several factors. They include increasing healthcare awareness, the growing prevalence of chronic diseases, improving healthcare infrastructure, rising disposable incomes, and government initiatives to promote domestic manufacturing and healthcare accessibility.
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India. It regulates medical devices for import, manufacture, sale, and distribution. Overall, the regulatory framework for medical devices in India, administered by the CDSCO, is aimed at ensuring the safety, performance, and quality of medical devices marketed in the country. Its mission is to also foster innovation and promote access to medical technology for patients and healthcare providers.
In this post, we’ll help you understand all about obtaining an Import license from CDSCO for medical devices.
Classification of Medical Devices
Medical devices in India are categorized into four distinct classes according to the risk they pose, and approval is required from CDSCO prior to marketing in India.
- Class A includes low-risk devices like thermometers, tongue depressors and many more.
- Class B includes low to moderate-risk devices like suction equipment.
- Class C includes moderate to high risks like lung ventilator.
- Class D includes high-risk devices like heart valves and implantable pieces of equipment.
Appointment of Authorized Indian Agent.
Medical Device Rule 2017 mandates the appointment of an authorized agent in India who must possess a license to manufacture or wholesale license for sale or distribution under these rules for making an application in Form MD-14 for obtaining an import license for medical devices from CDSCO through an online Medical Device SUGAM Portal.
The Authorized Indian Agent functions as the Legal Importer. Application is to be made in Form MD-14 and accordingly CDSCO issues the license in Form MD-15.So, if you have a Form MD-15 license, you can become a legal importer of medical devices in India.
The Process of Medical Device Registration in India.
Registration of medical devices is done in the following manner.
1. Classify your medical device according to the Classification list issued by DCGI.
To get a medical device import license, you must first classify your Medical Device as per the classification list published by DCGI based on the respective intended use.
2. Appoint an Indian Representative
If you are a foreign business manufacturer entity, then appointing an authorized business entity in India is essential. That person will be the point of contact for inspection authorities. They will assist in the registration process. The Indian authorization should have a drug license in Form-20B, 21B or Form MD-42.
3. Submit the application form.
Next, submit the application form for registration of the medical device. Your application must accompany all the technical dossiers of the medical device, its manufacturing process, and the safety and performance results. You must submit this form through the online Medical Device SUGAM Portal of CDSCO.
Essential Documents for Medical Device Registration
For successful registration and the procurement of a CDSCO medical device import license, you need to keep handy the following documents:
- Power of Attorney
- Free Sale Certificate
- Inspection Report
- ISO 13485 Certificate
- CE Certificate and CE Design Certificate
- Declaration of Conformity
- Manufacturing site or establishment registration copy.
- Plant Master File
- Device Master File
- Predicate device details
Payment of Registration Fee
There is a registration fee for producing or manufacturing medical devices and a fee for getting a CDSCO medical device import license in India.
- The registration fee to import licenses for Class A medical devices apart from in-vitro diagnostic medical devices is $1,000 for a single manufacturing facility and $50 for every single medical device.
- The fee for Class B medical devices apart from in-vitro diagnostic medical devices is $2,000 for one manufacturing facility. It is $1,000 for every single medical device.
- For Class A or Class B in-vitro diagnostic medical devices, the registration cost is $1,000 for one manufacturing site. It is $10 for every in-vitro diagnostic medical device.
- For Class C or Class D medical devices, apart from in-vitro diagnostic medical devices, the fee is $3,000 for a single manufacturing facility and $1,500 for every medical device.
- For Class C or Class D in-vitro diagnostic devices, the fee is $3,000 for a single manufacturing site. It is $500for a specific in-vitro diagnostic device.
Once you have submitted the relevant documents and given the fee, an application number will be produced.
CDSCO Application Review
The CDSCO will then analyze your application and the documents which you have uploaded. If any query arises, you will be informed. You need to answer the query to CDSCO’s satisfaction and submit the revised documents to the regulatory body’s online portal.
Approval of Import License for Medical Devices
CDSCO will review your application and validate every document. If they comply with CDSCO guidelines, you will receive the medical device import license in Form MD-15.
The Validity Period of the CDSCO Medical Device Import License
To ensure that your license stays valid, you must pay the license retention fee as specified in the Second Schedule of Medical Device Rules 2017.Importers should pay it every time before the completion of 5 years from the issuing date of the license unless the license is suspended by the Central Licensing Authority.
Steps to Import Medical Devices Without A Comparable Reference (Predicate Device)
Regulatory compliance for innovative devices without a predicate is slightly challenging. You require permission in Form MD-27 from the Central Licensing Authority (CDSCO). Follow these steps:
- Submit an application in Form MD-26 through the online SUGAM portal for Medical Devices.
- It serves as the official request for approval to import innovative devices.
- The Central Licensing Authority will review your application comprehensively.
- If the review is successful, the license will be given as Form MD-27.
- A fee of Rs 50,000 is applicable for each distinct device.
Benefits of Being A CDSCO License Holder
CDSCO Import license grants bring many benefits. These include:
Being a Central Drugs Standard Control Organization (CDSCO) import license holder in India comes with several benefits, especially for businesses involved in importing medical devices into the country. Some of these benefits include:
- Market Access: With a CDSCO import license you can legally import medical devices into India. Thus, it becomes easy to access a fast-growing healthcare market.
- Compliance with Regulatory Stipulations: Obtaining a CDSCO import license ensures that you abide by the regulatory requirements set by the Indian government. Your compliance with the regulations for importing medical devices helps in avoiding legal issues and penalties. Also, it prevents delays in customs clearance.
- Credibility and Trust: Possession of the import license for medical devices enhances the credibility and trustworthiness of the importer. You turn more reliable in the eyes of regulators, healthcare professionals, and consumers. It demonstrates your deep commitment to quality and safety. The license clearly shows your adherence to regulatory standards.
- Access to a Diverse Market: India has a diverse and rapidly expanding healthcare market. The demand for medical devices across various segments is growing every year. So, keeping a CDSCO import license allows you to leverage it fully. You can explore the many opportunities for growth and expansion.
- Competitive Advantage: Being a licensed importer under CDSCO gives is much beneficial in the long run. It gives you an edge over unlicensed ones. The approval of the license permits you to participate in government tenders and collaborate with healthcare institutions. You can also establish lucrative partnerships with manufacturers and distributors.
- Facilitates Distribution and Sales: The import license streamlines the distribution and sales process for imported medical devices in India. This process gives you the ability to navigate customs procedures. You can quickly get the necessary permits. Further, the process of distributing products to healthcare facilities and end-users also becomes more efficient.
- Opportunities for Collaboration: A CDSCO import license opens up opportunities for collaboration and partnerships with domestic manufacturers. You can explore options for partnering with distributors and other stakeholders in the current healthcare ecosystem.
- Adaptation to Regulatory Changes: The CDSCO import license holder stays abreast of regulatory changes. This knowledge about the changes in the Indian medical device sector lets you adapt your import strategies and ensure continued compliance with evolving regulations.
Simplify the Process of Getting A CDSCO Medical Device Import License with Dueran Consultant
Dueran Consultant is a leading medical device consultant in India. We have helped thousands of importers in getting import licenses for selling their medical devices in India. Our experienced professionals have enabled medical device importers to obtain Form MD-14, Form MD-27 and Form MD-42 for their medical devices. From classifying medical devices, creating your CDSCO portal credential, and preparing and reviewing documents to fee payment, we are there to ease every step of this complex journey.
Our experts have deep knowledge of the constantly evolving regulatory framework in India and can easily expedite the process of getting approval. We work with the department official on your behalf. When you choose us, we guarantee you that you will get the approval to import medical devices on time.
Dueran Consultant creates custom regulatory solutions and strategies to help ease the process of getting a license according to business needs. With us by your side, you don’t need to feel trapped amid complex regulatory laws and rules. We’ll guide you to success, so you are able to get a license hassle-free and expand your market reach.
Contact us today to kick start the process of getting your device approved in India.
