What is the Purpose of Form MD-3 and Form MD-5?

Form MD-3 and Form MD-5
Karan Singh
| Updated: Oct 20, 2022 | Category: CDSCO

In India, the manufacturing of medical devices requires strict processes to be completed under the Rules & Regulations of CDSCO (Central Drug Standard Control Organisation). Moreover, the applicant or manufacturers who want to manufacture Class A/Class B devices have to go via a procedure by applying for a Medical Device Manufacturing License to distribute or sell medical devices. The Central Drug Standard Control Organisation ensures the safety & quality of medical devices sold in the market. Such applicants need to apply to the SLA (State Licensing Authority) for the approval from the Ministry of Health& Family Welfare, depending on the applicant’s location. An application for Registration has to be submitted in Form MD-3 with the vital documents for securing a Manufacturing License in Form MD-5. Scroll down to check more information regarding Form MD-3 and Form MD-5.

Different Categories of Medical Devices in India

As per the Medical Rules, 2017, all medical devices in India have been classified into 4 different categories such as:

  • Class A
  • Class B
  • Class C
  • Class D

Any Company that wants to manufacture these devices for distribution or sale must apply for a Manufacturing License with CDSCO. Class A and Class B Medical Devices are considered low-risk and moderate-risk devices, respectively. The application for manufacturing of medical devices falling under these classes must be filed with the SLA (State Licensing Authority). On the other side, Class C & Class D Medical Devices are categorised fied as high and very-high risk, respectively.

Purpose of Form MD-3 and Form MD-5

You can check the purpose of Form MD-3 and Form MD-5 from the table mentioned below:

Form Name Purpose
Form MD-3 This is an application form for the issuance of a License to sell, distribute, or manufacture Class A or Class B Medical Devices in India.
Form MD-5 This is the License to sell, manufacture, or distribute Class A or Class B Medical Devices given by the State FDA on examination of all documents& their approval.

Who can apply for the Permission to Manufacture Class A or B Medical Devices through Form MD-3 and Form MD-5?

Any authorised medical device producer having a valid Wholesale Manufacturing License can apply to get Permission to Manufacture Class A or B Medical Devices in India. According to the regulations, manufacturers can opt for the same via Form MD-3 and Form MD-5.

Documents Required for Obtaining Manufacturing License for Class A & B Medical Devices through the Form MD-3 and Form MD-5

Following are some vital documents required for Manufacturing License for Class A& B Medical Devices through Form MD-3 and Form MD-5:

  • Site Master File (SMF) and Device Master File (DMF);
  • Documents relating to QMS (Quality Management) System.

Following are some other documents that should be submitted by the applicant:

  • Application Form;
  • Cover Letter;
  • Report on the Performance Evaluation (if applicable);
  • A DMF for each product (as per the 4th Schedule’s Appendix II & III);
  • PMF (as per Appendix I of Part III of the 4th Schedule), in addition to the information that is needed as per Appendix I of Part III of the 4th Schedule, the following documents are required to be submitted:
  • Educational qualification, experience, & approval certificate of proposed Analytical Chemist, Manufacturing Chemist, Appointment Letters, and Identity Proof;
  • Declaration of the Manufacturing Chemist;
  • Declaratory Statement of the Analytical Chemist;
  • Registration through the District Industries Centre.
  • Company’s Organisation Structure, including:
  • Memorandum of Association (MOA) and Articles of Association (AOA);
  • Partnership Deed;
  • Declaration of the Partner, Director, owner, & Managing Director (MD) of the Company;
  • Documents related to the site ownership and the Tenancy Agreement;
  • A guarantee that the location where the product or item is manufactured complies with requirements stated in the 5th Schedule.

Procedure for Obtaining Medical Device Manufacturing License of Class A & B Medical Devices

Following is the procedure for getting a Medical Medical Device Manufacturing License of Class A& B Medial Devices through Form MD-3 and Form-5:

  1. Filling of an Application: First, the applicant needs to file the application for (Form MD-3) and submit the same along with all the relevant documents to the State Licensing Authority for sales, manufacturing, or distribution of Medical Devices. The applicant must also submit the required fees challan, which can be found in the fee chart under the section Forms & Fees.
  2. Examination Process: Once the applicant submits the application, then the authority will examine the application and documents submitted by the applicant.
  3. Audit of the Factory Premise by a Notified Body: In case of any violations, the applicant or the manufacturer is responsible for making the required corrections. The notified body is liable for uploading both the closure notification & audit report. Once the audit report has been received, it will be examined, and if it is determined to be enough, then it will be sent on to a further phase.
  4. Scrutiny of Goods & Services: The products’ specifics that have been requested will be scrutinised, and if it is found that they are in accordance with the specified standards, then the application for the Manufacturing License will be taken into consideration for the issuance of a Manufacturing License.
  5. Issuance of License: After the above step, the State Licensing Authority will issue the manufacturer permission & the Medical Device Manufacturing License[1] for Class A & Class B Medical Devices in Form MD-5.

Conclusion

So basically, the application Form MD-3 and Form MD-5 are used to get a Medical Device Manufacturing License for Class A & B Medical Devices. Any authorised medical device producer having a valid Wholesale Manufacturing License can apply for Permission to Manufacture Class A or B Medical Devices in India.

Read our Article:What is the Meaning of Form MD-8 and Form MD-10?

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Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

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