In India, the Central Drugs Standard Control Organisation (CDSCO) oversees the regulatory system for medical devices, under the Directorate General of Health Services and the Ministry of Health and Family Welfare (MoHFW). As per the Drug and Cosmetics Act, 2017, it is essential for manufacturers to follow the process of Application Forms MD-5 and MD-9 set by the CDSCO to obtain Medical Device Manufacturer License.
ELT Corporate offers a streamlined Manufacturer License service that transforms your product ideas into reality. This licence allows you to produce, assemble, package, and label medical devices for commercial distribution. In order to ensure that the medical devices produced satisfy the appropriate quality and safety requirements, it is essential to obtain a Medical Device Manufacturer licence.
If you are looking to get Medical Device Manufacturer Registration with a trusted and skilled CDSCO Consultant in India, then ELT Corporate provides regulatory and compliance consultancy
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A medical device is any instrument, apparatus, machine, appliance, implant, reagent for in-vitro use, software, material or related article, used for a medical purpose, such as diagnosis, treatment, or prevention of disease or injury. As per the Indian Medical Device Rules (IMDR) 2017, medical devices are classified into four classes based on their intended use and potential associated risk.
A Medical Device Manufacturer Registration License is a document issued by the government. It is an approval of medical devices products of any risk classification for manufacturing in India.
The applicant can apply for manufacturer registration through the online portals of the Ministry of Health & Family Welfare (MoHFW). According to the product classes, you have to fill out the form of application. License for class A & B Forms MD-3 and MD-5 are used. In these forms, you have to mention manufacturer information in the MD-3 form and In MD-5 you have to submit all necessary documents.
For the class C & D, you have to fill in the form MD-7 and MD-9 to obtain the license. MD – 7 form is used for the permission for the sale & distribution of medical devices to manufacturers. And MD-9 is formed for the license for the same.
To obtain the Medical Device Manufacturing license for any class of Medical Device, multiple steps are followed as per Regulatory compliance. The application form is filled through online SUGAM portal and all the documents must be submitted along with the application form to start sell and distribution of medical Devices.
A Medical Device Manufacturer Registration License is a document issued by the government. It is an approval of medical devices products of any risk classification for manufacturing in India.
Read Now| Central Licensing Authorities (CLA) | State Licensing Authorities (SLA) |
|---|---|
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Import of Medical Device & Manufacture Of Class C & D Medical Devices |
Manufacture for sale or distribution of Class A and Class B Medical Device. |
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Registration of laboratories for carrying out tests or evaluation. Notified body get registered under CDSCO |
Sales, Stock, Exhibit or offer for sale or distribution if IVDs of all Classes. |
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Clinical performance evaluation and approval of new In-Vitro diagnostic |
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Ensure Safety Of The Medical Devices
Build Customer Trust
Enhance Brand & Product Reputation
Provide Legal Protection
Allow You To Sell Your Device Legally
Any person who wants to start a manufacturing business of medical Device
Any existing importer or Manufacturer who is willing to start medical device business.
Any authorised person on the behalf of Manufacturer or importer
For the manufacturer registration license just follow the below-mentioned process:-
The application must be submitted online under form MD-12 & the grant of license is under Form MD-13 which also called as Test License. On the successful grant of test license, manufacturers of Medical devices are allowed to manufacture a small number of medical devices as samples to ensure the safety & efficacy of the medical device before it is released in the market. For all product classifications i.e. class A, class B, Class C, and class D: application for a test license in MD-12 is mandatory to apply for the final manufacturing license.
After the submission and approval of the test license application, we apply for the final manufacturer license on the SUGAM portal. In case a query is raised against any of the above mentioned list of documents it must be answered provided with appropriate documents.
| Medical Devices (as per their risk classification) | Application/Grant Form Needed |
|---|---|
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For Class A & B |
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For Class C & D |
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After Submission of Mfg. License application Notified body gets allotted in case of MD 5 and In case of MD 09 CDSCO Comes with a subject expert for inspection of your manufacturing site, after 45-60 days normally.
Allow an inspection of the manufacturing site by the respective inspection body:
| Medical Devices (as per their risk classification) | Inspection |
|---|---|
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For Class A & B |
Notified Body assigned by the SLA (State Licensing Authority) |
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For Class C & D |
CDSCO (Central Licensing Authority) |
During inspection, the Notified body (in case of MD05) or CDSCO Auditor (in case of MD09) may or may not raise some NC’s (Non-Conformities). Upon satisfaction from the audit Notified Body or CDSCO Auditor submit the audit report to the State Licensing Authority (State FDA) or Central Licensing Authority (CDSCO).
After submission of your inspection report to your respective licensing authority, they will review your application form, legal documents and technical documents. In case of any confusion or doubt Licensing authority will raise a query on your file on Sugam Portal and your need to resolve these queries accordingly.
Once the application file and documents are validated and reviewed, the manufacturing license gets granted.
Following are the key documents an applicant must submit to obtain the medical device manufacturing license, in accordance with the CDSCO, Medical Device Rules, 2017:
ELT Corporate Experts ensures compliance with the Medical Device Rules, 2017, by guiding you through every audit step. Our experts evaluate your facility, quality management systems, risk management, validation, and manufacturing processes.
Book a free consultation to streamline your MD 5 License approval!
The medical device registration for manufacturer is different as per the medical device category. It is also varies as per the requirement of the manufacturer. The fee of the medical device manufacturer registration as follows:
| Medical Devices (as per their risk classification) | Fees |
|---|---|
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For Class A & B |
The Application Form Charges 5000 INR for each manufacturing site and 500 INR for each distinct class A and class B medical device |
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For Class C & D |
The Application Form Charges for class C and D medical Devices is INR 50,000 for each manufacturing site and INR 1000 for each distinct class C and D Medical Devices. |
The validity of Medical device manufacturing license is Five years from the date of issuances after this time license must be renewed in the given time of 45 days otherwise fine will be imposed or it will get expire.
The timeline for medical device manufacturing license depends on all the processes but, generally, it is 6 to 9 months. For smooth and quick application you can take the help of experts.
Contact ELTCorporate Experts today! Our team of experienced professionals will help you navigate the complex regulatory process and ensure a smooth MD-5 license approval.
With ELT you enjoy following process ease benefits:
You must inform the State Licensing Authority within 45 days and apply for a new license within 180 days. Your existing license remains valid until the new one is granted or rejected.
You can appeal the decision to the State Government within 60 days.
The State Licensing Authority conducts unannounced inspections at least 2% of the time.
If you violate regulations, your license may be suspended or canceled. You will have the opportunity to defend your position before a final decision is made.
Yes, you can appeal within 45 days, and a hearing will be scheduled.
Your facility must have an ISO 13485 or ICMED 13485 certified Quality Management System, and you must appoint competent technical personnel for manufacturing and testing.
The fee is ₹5,000 per site and ₹500 for each distinct device, as outlined in the Second Schedule of the Medical Device Rule, 2017.
The license is valid indefinitely as long as you pay the retention fee every five years.
It typically takes 3 to 6 months from application to approval.
It typically takes 3 to 6 months from application to approval.
ELT Corporate is a regulatory consultant with over 15 years of experience in helping companies navigate the licensing process.
Focus on documentation, facility readiness, device testing, risk management, and team training to ensure compliance and readiness.
ISO 13485 is essential for demonstrating competence in the quality management of medical devices, ensuring compliance with regulatory requirements.
Private Notified body comes for the audit at Mfg. site and they review the 4th and 5th Schedule. https://cdscomdonline.gov.in/NewMedDev/ListOfNotifiedBody
