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Import License of Predicate Medical Device MD-14

Looking to Import Medical Devices in India? Here’s How to Get an Import License

In order to import medical devices into India, you need to be able to navigate the complexity of India’s regulatory environment. This process begins with a fairly simple first step — getting an “Import License for Predicate Medical Device — MD-14”.

According to Chapter V of the Medical Rules, 2017 below applicants can apply for a license to import medical devices. 1. Any authorised agent having licence to manufacture for sale or distribution 2. Any authorized agent having wholesale license for sale or distribution shall make an application for grant of import license for medical device.
The license is granted by the CDSCO(Central Drugs Standard Control Organization), Ministry of Health and Family Welfare. There is an online portal for medical devices through which the entire process can be done — you need to use Form MD-14 to apply.
The CDSCO periodically releases a list of Medical Device Rules, and the latest rules are listed on their website.
The applicant must submit a valid wholesale/manufacturer license for medical devices. If you don’t have this license, you’ll need to apply for it first. Since December 2017, all applications need to be made through CDSCO’s Medical Device Sugam Portal.
Here are the main documents: ● Cover Letter ● Power of Attorney ● Free Sale Certificate ● Quality certificates from the foreign manufactures (ISO 13485, CE Certificate) ● A device master file (specifying technical and safety-related information) ● Test data of the medical device ● A plant master file, with details about the manufacturing procedure of the device.
The application needs to have a cover letter in a very specific format with complete details of product, manufacturing site.
You need to submit a Free Sale Certificate with your application. This is a document that certifies that the medical devices you will import are freely sold in the exporting country and have been approved for export.
The process for approval is tedious and goes through several stages. Once you apply on the portal, the application is received by a Nodal Officer. It’s then forwarded to the Reviewing Officer, who reviews the documents and returns it to the Nodal Officer, who then forwards it to the DA/DDA. If there is any deficiency in documents, it goes back as a query to the applicant. If all the documents are in order, it’s forwarded to the LA, and then approved.
Medical Device

Application to manufacture Class C & D Medical device in India MD-7

Do You Want to Manufacture Class C and D Medical Devices in India? These are the Permissions You Need

Class C and D medical devices come under the moderate high risk and high-risk category in India, which means you need to take a range of permissions to begin manufacturing these devices.

If you’re looking to begin manufacturing Class C and D medical devices, you’re looking at the following permissions: ● Getting permission to manufacture the devices
To get the necessary permissions, you need to file an application with the CDSCO (Central Drugs and Standard Control Organisation) through online portal in Form MD-7.
The CDSCO periodically releases a list of Medical Device Rules, and the latest rules are listed on their website.
Cover letter You need to summarize the entire purpose of your application in a cover letter. This is one of the most critical documents because even a slight mistake in the cover letter means your application might get rejected. Test license You also need to have a license for testing and generating quality control data for the medical device. Essential principles list This is another area where your application has to be foolproof. This list defines any known hazards or risks associated with the use of the medical device. Once again, this list needs to be created very precisely and is best done by an expert. Establishing equivalence You also need to create a document that defines the substantial equivalence of the medical device to a predicate device. Other important documents These include the device master file and the plant master file. These contain details technical and clinical details about the device, along with safety and manufacturing-related facts.
The process for approval is tedious and goes through several stages.. Once you apply on the portal, the application is received by a Nodal Officer, from where it’s forwarded to the Reviewing Officer, who reviews the documents and returns it to the Nodal Officer, who then forwards it to the DA/DDA. Any deficiency in the documents is identified here, and the application is sent back to the applicant to make the necessary changes. If all the documents are in order, it’s forwarded to the LA, and then approved.
Medical Device

Application to manufacture Class B Medical device in India MD-3 (Medical Device)

Are you looking to manufacture a Class B Medical Device in India? Here’s what you need to know

While Class and Class B devices are considered low to moderate risk devices, the application process for permissions can still be quite cumbersome.

If you want to manufacture Class A or Class B medical devices in India, you need to have a manufacturing license. If you need a loan to start this business, you will have to get separate permission for the loan license.
To get these permissions, you need to file an application with the State Licensing Authority. You need to file Form MD-3 for the grant of manufacturing license and MD-4 when you’re applying for a loan license. Since 1st April 2016, all applications need to be made through CDSCO’s Sugam Portal.
Cover letter You need to summarize the entire application through your cover letter. Drafting this letter with care and expertise is a must, as applications often get rejected on the basis of the cover letter alone. Test license You also need to have a license for testing and generating quality control data for the medical device. Other documents These include the device master file and the plant master file. These contain details technical and clinical details about the device, along with safety and manufacturing-related facts.
The process for approval is tedious and goes through several stages.. Once you apply on the portal, the application is received by a Nodal Officer, from where it’s forwarded to the Reviewing Officer, who reviews the documents and returns it to the Nodal Officer, who then forwards it to the DA/DDA. Any deficiency in the documents is identified here, and the application is sent back to the applicant to make the necessary changes. If all the documents are in order, it’s forwarded to the LA, and then approved.
Medical Device

The application process can become quite a hassle, especially as every State authority has its own specific regulations. If you’re looking to simplify the application process so that you can focus on the actual business, reach out to us. At CliniExperts we have a network of experts across India, enabling you to easily file your application in any state in the country.

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