Introduction: Medical Drugs and Medical Devices

In this Blog, we will be discussing the licensing mechanism for Medical Drugs and Medical Devices as through the recent amendment we have seen that the Medical devices have been put outside the license of Medical Drugs. Now the Wholesaler, Vendor needs to have a separate license for the sale and distribution of Medical devices. From the recent amendment made on September 20, 2022, these changes have been made to the Medical devices rules 2017.

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Till now, we deal with the Drugs and Cosmetics Act, of 1940 for medical devices and Drugs, and all medical devices were treated as Drugs and regulated as per the Drugs & Cosmetics Act and Medical Devices Rules 2020. Let's discuss what is Medical Device licensing and Medical Drug licensing and the main differences in licensing of Medical Devices and Drugs in India.

Background

The Indian Medical Device Regulations, 2017, on the basis of which the Medical Device Licensing form MD-41 and the Medical Drug Licensing form MD-19/20B/21B have been issued by the Ministry of Health & Family Welfare, Government of India.

The Indian Medical Device Regulations, 2017, apply to any medical device that is manufactured or imported into India for use in any clinical area for diagnosis, treatment, or prevention of a disease or for the promotion of good health.

The Indian Medical Device Regulations, 2017, are available on the website of the Ministry of Health & Family Welfare.

Medical Device Licensing form MD-41

As per the recent changes brought in the Legislature through which separate licensing is required to be done for the Medical Device wholesalers in Medical Device Licensing form MD-41 through the Director-general of Health Services. As per the Central Drugs Standard Control Organisation the importer or Manufacturers of Class A and Class B medical Devices, have to submit the application to the Central Licensing Authority before coming into force of the amended provisions of Medical Devices rules, 2017. The government has granted 6 months time period from the Effectiveness of a new amended Compulsory Device Licensing form MD41, through the 87A introduced in the 2017 rules, which is implemented for Class A and Class B Medical devices which are considered very low-risk devices, permission shall be granted by the State Licensing Authority. There are two more categories of medical devices that are Class C and Class D which are categorized as very high-risk category Devices, the licenses of the devices of these categories are granted by the Central Licensing Authority.

Documents to be Uploaded Along With The Application Form of Device Licensing Form MD-41

• ISO 13485 Certificate.
• TR6 Challan.
• Cover Letter (Describing your experience and skills).
• Challan fees (copy).
• Memorandum of association and Article of Association (proof of Constitution of the firm).
• Declaration of Managing Director(s)/Proprietor/ Partners.
• List of all the Directors/Partners with age & complete postal & residential.
• Address.
• Documents of ownership or Tenancy agreement.
• Plant Master File

Following Documents Should Also be Submitted.

• Id proof (Aadhar card, PAN card, etc)
• Declaration of Analytical Chemist.
• Declaration of Manufacturing Chemist.
• Documents of educational qualification, experience, and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters.
• Registration from District Industries Centre. 

Medical Drug Licensing Form MD-19/20B/21B

For the sale and distribution of Wholesale drugs by a business or Startup, a wholesale drug license in forms 20, 21, 20B, and 21B is required.  It is made mandatory through the regulation for granting a Wholesale License. It is governed by the Drugs and Cosmetics Act, of 1940.

This is required for manufacturing pharmaceuticals, sale, distribution, or storage of the medication. Through the license you prove yourself as an authorized person with an authorized business for manufacturing and distributing pharmaceuticals, it is illegal to manufacture drugs in India without registration.

The government has complete control and authority to regulate the import and export of medicine, and head to regulate the Consumption of Schedule H & X drugs, etc.  

Once the license is granted, its validity remains perpetual or till the suspension of the same through the Drug Inspector, for the retention of the license the licensor needs to pay Rs. 3000 as a retainer fee. 

Documents To Be Uploaded Along With The Application Form Of Licensing Form MD-19/20B/21B:

• ISO 13485: 2016 Certificate
• TR6 Challan.
• Cover Letter (Describing your experience and skills).
• Application Form (along with Proof of qualification, Registration Certificate of Chemist/Experience certificate, and appointment letter).
• Challan fees (copy).
• Memorandum of association and Article of Association (proof of Constitution of the firm).
• Declaration of Managing Director(s)/Proprietor/ Partners.
• List of all the Directors/Partners with age & complete postal & residential address.
• Documents of ownership or Tenancy agreement.
• Plant Master File.

Following Documents Should Also Be Submitted:

• Id proof (Aadhar card, PAN card, etc)
• Proof of drug storage at the site.
• Declaration of Analytical Chemist.
• Declaration of Manufacturing Chemist.
• Documents of educational qualification, experience, and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters.
• Registration from District Industries Centre. 

Here at Corpseed

We are proud to provide a wide range of services to our clients from India, the UK, and other countries. Our experts are well-versed in the regulations and standards of the country, enabling them to help you get your product successfully launched in India.

We can help you with all the procedures required for medical device and drug licensing, such as

• Medical device registration/approval
• Medical device classification
• Medical device labeling, including pre-market notification
• Product quality audit
• Product testing and evaluation
• Product registration and approval
• Product labeling, including pre-market notification
• Product registration and approval for imported products
• Product testing and evaluation for imported products
• Product quality audit of imported products
• Medical device classification and labeling, including pre-market notification for imported products
• Product testing and evaluation of imported products

We also offer a wide range of post-marketing services to add extra value to your product, such as

• Quality assurance programs
• Clinical performance monitoring 
• Field investigator support
• Clinical study support
• Regulatory activities
• Clinical data