How to Obtain a CDSCO License for Medical Devices in India?

If you are a company founder and your company is related to selling or manufacturing medical devices. Then this becomes your responsibility to check whether they are safe or not. Or are they fully licensed or not? So, in this case, surely the CDSCO license for medical devices will help you a lot.

Thus, this article is gonna teach you about the role of CDSCO medical device registration and the procedure for obtaining this license in India. 

The CDSCO license, which is issued and mandated by the Central Drugs Standard Control Organisation. Basically, the role of this license is to ensure that the medical devices that you are selling or manufacturing are fully safe and certified. Before their usage purposes. Everyone knows that medical devices are used for many sensitive purposes like operations, curing, stitches, etc. 

So, for this case, if those medical devices are not certified and fully capable of working. Then they might cause many serious issues for any kind of person. Also, selling or manufacturing medical devices without having a CDSCO license can lead to several fines and penalties for your business. Thus, to get your CDSCO manufacturing license for medical devices, learn about the process of obtaining it more briefly with this blog.

1. By What Steps Can One Obtain a CDSCO License for Medical Devices?

Now, if you also want your CDSCO license for your business, in terms of selling medical devices smoothly. Learn about the process of getting it easily without taking up any time taking things. 

To obtain your CDSCO License Registration for your medical devices. Firstly, you need to register your business on the SUGAM portal, and then you have to classify your medical devices. After which, collect and prepare some important documents like the Device Master File (DMF) & Plant Master File (PMF). Then, after these, pay the required fees and submit Form MD-14/MD-15 (for import/mfr) online, followed by potential inspections and final approval in Forms MD-5/MD-6. 

So, this is the short process. Now take a look at a more brief process of getting your CDSCO license easily for your medical equipment:

1. Pre-Application Steps

• Before applying for your CDSCO license, you need to check the classification of your devices. That means you have to determine your device’s risk class (A, B, C, D) as per the 2017 Medical Device Rule. And in the case of importing, you need an Authorised Indian Reseller (AIR). Then, after these steps, you have to create an account on cdscoonline.gov.in. 

2. Document Preparation 

• Then, after the previous steps, you have collected and prepared some required documents. The device Master File is part of this & Plant Master File. ISO 13485, CE Certificate/Declaration of Conformity, Free Sale Certificate, QMS compliance, legal undertakings. Also, Identity/Address Proof, and duly legalised for importers. 

3. Application Submission 

• After collecting all the documents, you can go with the application submission. Submit your application in some specific forms, such as MD-14 for Class A/B, MD-15 for Class C/D. After which, pay the required fees and upload the challan. 

4. Review & Inspection 

• Then, after all these steps, the CDSCO will review your documents for completeness. Also, for some higher-class cases, an inspection is also required of the manufacturing site. Which is important. 

5. Approval & Licensing 

• When your application and documents are successfully reviewed. The authority of CDSCO is issues will issues your CDSCO license for medical devices in the form MD-5/MD-6. Also note that the form MD-15 is made for importing items under classes A, B, C, & D devices. 

2. What Mistakes Slow Down the Process of the CDSCO License in India?

Also, learn about those errors or mistakes that impact the process of your CDSCO license for medical devices, and these mistakes will impact your procedure. 

Mainly, during the time of CDSCO registration, many businesses or founders make many types of mistakes or errors, which cost them heavily. Thus, the list of mistakes includes such errors as documentation errors, procedural lapses, and incorrect classification of medical devices. Also, poor QMS and delays in responding to CDSCO queries or inspections, leading to rejections or long waits. 

Now, learn more briefly about those errors and mistakes that many businesses make during the time of CDSCO registration:

1. Documentation Errors 

• Due to providing the Missing Device Master File (DMF), Plant Master File (PMF), and Free Sale Certificates (FSC). And test reports, or technical data, can lead to registration errors. 
• By using old versions of CDSCO forms, or due to not following the specified formats. Also, having incorrectly formatted documents or failure to get them legalised/apostilled when needed.

2. Procedural and Portal Problems 

• Many businesses also cause Incorrect fee amounts or a lack of payment confirmation proof that can impact their registration process. And many times the registration process is also affected due to Technical glitches, incorrect user registration, or failure to track status. And many times, businesses sign forms with people not authorised by the company.

3. Misclassification 

• Many times, incorrectly classify your device. Leads to significant changes in the application route and requirements, causing major delays if wrong.

4. Quality Management System (QMS) Failures

• Many small businesses also face failure in quality management systems due to poor implementation or readiness for inspections, which leads to non-compliance findings.

5. Communication Lapses 

• Due to not responding to queries and updates of CDSCO properly, or due to not submitting the required documents/proofs on time. Then this can also lead to delays and issues during the registration of CDSCO. 

6. Indian Authorised Agent (IAA) Issues 

• Choosing an inexperienced or unlicensed IAA can lead to health businesses with compliance risks and delays during the time of CDSCO application and registration. 

3. Who Must Apply CDSCO Before Selling Devices in India?

Exactly, what are those businesses that need to apply for Medical device regulatory approval in India before selling any type of medical devices in India? Learn about those with this blog, and check whether your business is included in this list or not.

Basically, we can say that anyone who is involved in selling or manufacturing medical devices in India is involved. Whether it is a domestic manufacturer, an importer, or a foreign company. All of these must apply for a CDSCO license with the CDSCO (Central Drugs Standard Control Organisation) website to ensure safety and quality, primarily through the Sugam portal.

The process of applying for these businesses involves classifying your device (Class A, B, C, D) and submitting specific forms like MD-3 for manufacturers, MD-15 for import licenses. With the help of documents that often require a local authorised agent for overseas entities.

• Indian Manufacturers – Any type of Indian manufacturer or seller must have a CDSCO license, like form MD-3. For their business and medical devices.
• Importers – Those businesses which are involved in importing must obtain an import license, like form MD-15.
• Foreign Manufacturers – Any outside or foreign manufacturer also needs to appoint an Authorised Agent or Indian Subsidiary to apply on their behalf. 

4. Want to Sell Your Medical Devices? So Get Your CDSCO by LegalRaasta!

There are many challenges to running a business. However, at LegalRaasta, we make compliance with CDSCO Registration, ESI registration, and GST filings easier so that Company Owners can focus on growing their Business. In addition, by streamlining these areas for Companies, we assist Companies in becoming compliant and lowering the risk associated with Non-compliance issues.

As we also provide:

• Medical device registration in India,
• Company registration,
• LLP registration,
• NBFC registration

Our team of Experts will develop a customised solution specific to your Business, whether it be for CDSCO Registration, GMP Certification, Virtual CFO Services, etc. Across the spectrum of Start-up Companies to large Corporations. We have made it simple and easy to implement Legal, Financial, and Compliance requirements.