Application Procedure for Class A and B Medical Devices

The Central Drug Standard Control Organisation (CDSCO) released the medical device rules in the year 2017. The rules came into force in the year 2018. These rules cover all the regulations for medical devices and IVD devices in the country. The rules classify the devices based on their risk, with Class A being the least risky and Class D being the most risky. A manufacturer needs to apply for must apply for the ‘Medical device manufacturing license’. In the case of classes A and B, the application needs to be filed with the State licensing authority; in the Case of C and D, the application needs to be sent to the Central Licensing authority. This article shall show the application procedure for Class A and B Medical Devices.

What are the forms required for Class A and B Medical Devices registration?

Following forms are required for Class A and B Medical Devices Registration

The following forms are required for Class A and B Medical Devices Registration.

• Form MD-3: The manufacturer must make an application under Form MD-3 to obtain the license for the manufacture, sale and distribution of the Class A and Class B medical devices in India.
• Form MD-4: This is the form in which the application for the Grant of a loan License is to be made by the manufacturer in case he wants to obtain a Loan license for Class A and Class B medical devices in India.
• Form MD-5: This is the form in which the license to manufacture for sale and distribution of devices that fall under Class A and Class B is granted to the manufacturer
• Form MD-6: This is the form in which the Loan license to manufacture for sale or distribution of medical devices for Class A and Class B is granted to the manufacturers.

Which Authority is responsible for granting registration for Class A and Class B medical Device registration?

A manufacturer must send the application to the State licensing authority. The State licensing authority shall grant the licenses to manufacture and distribute Class A and Class B medical devices. The authority shall also grant the loan license to the manufacturers.

What is the fee applicable for Class A and Class B medical Device registration?

The manufacturer needs to pay the following fee for Class A and Class B medical Device registration:

• Fee For manufacturing license to manufacture Class A and Class B medical devices:
  • For manufacturing registration: ₹ 5,000
  • For distinct medical devices: ₹ 500
• Fee For Loan license for manufacturing license to manufacture Class A and Class B :
  • For manufacturing registration: ₹ 5,000
  • For distinct medical devices: ₹ 500

Documents required for Class A and Class B medical Device registration?

The following documents are required for Class A and Class B medical Device registration

• Covering letter
• Application form
• Copy of fees paid
• Details of the firm such as
  • Memorandum of Association, Article of association/ Partnership deed
  • Declaration for partners, directors, proprietors etc
  • List of all the Directors. Partners with their contact details and postal address
• Documents for the plant site- ownership documents or tenancy agreement
• Plant master file ( as per appendix I part 3 of the fourth schedule)
• Declaration of the manufacturing and analytical chemist
• Documents of qualification, experience, appointment letter and Id proof of Chemist
• Device Master file for the medical device product
• Performance evaluation certificate (in available)
• Undertaking stating site is compliant with the provisions of 5^th schedule
• Consent letter of the principal manufacturer (for Loan license)
• Copy of Wholesale license (for Loan license)

Process of application for Class A and Class B medical Device registration

The following process must be completed for Class A and Class B medical Device registration:

1. The applicant must get themselves registered at the SUGAM portal of CDSCO^[1].
2. The manufacturer must apply for a license to manufacture medical devices from Class A and Class B through form MD-3
3. The application must apply for the Loan license for medical devices in the form of Class A and Class B through MD-4.
4. The forms must be uploaded with the fee for the purpose as stated in the article before. i.e. ₹ 5000 for the registration of a manufacturing plant and ₹500 for the registration of a product for Class A and Class B.
5. The applicant must fill in all the relevant details as required by the form.
6. The applicant must submit all the documents mentioned before.
7. The State licensing authority shall take about 45 days for the scrutiny of the application and the documents provided by the manufacturer.
8. If satisfied with everything, then the State licensing authority shall grant the license to the applicant via MD-5 (approval for the manufacturing license) and MD-6 (Approval for the loan for the manufacturing license).
9. In case the application is rejected by the State licensing authority, the applicant has the right to rectify and reapply within a span of the next 45 days.

Validity of the Class A and Class B medical Device registration

The validity of the Class A and Class B medical device registration received in forms MD-5 and MD-6 is for a period of 5 years. If, due to any reason the license is cancelled or suspended by the State licensing authority, then the applicant can apply for the same within the next 45 days.

Conclusion

The government has laid down regulations and guidelines for medical devices in the country by introducing the Medical device rules of 2017. The regulations have divided medical devices into categories based on the risk profile. This blog dealt with the registration of Class A and Class B devices.

Read our Article:CDSCO Medical Device Loan License