From Lab to Clinic: The Role of MD-22 & MD-23 in the Medical Devices Market

In the Indian market, where medical device manufacturers were two terms arrives MD-22 and MD-23. MD-22 is a type of application that is submitted to the Central Drugs Standard Control Organization (CDSCO) for gaining permission to conduct a clinical investigation for medical devices. The form that is referred to as MD-23 is an official approval granted by the CDSCO to carry out the clinical trial. Mainly, these forms are part of a regulatory process under the Medical Device Rules, 2017, for ensuring the safety and reliability of the new medical devices. 

What are MD-22 and MD-23 in the Indian medical sector?

From MD-22 – This is a type of application that you have to submit to the CDSCO registration for obtaining permission to conduct an investigation of a clinic for investigating medical devices. Manufacturers or importers primarily use this to research new medical gadgets. The application that you submit can be submitted through the SUGAM portal, which also requires the submission of documents, like the  Clinical Investigation Plan.

Form MD-23 – This form is known to be an official permission form, which is also issued by the CDSCO license registration in India. Official permission for conducting clinical investigations for new or investigational medical devices. It’s a mandatory document for manufacturers and importers in India. This form also ensures that the clinical investigation plans the safety data and overall trial design that meet the requirements of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. 

Why are MD-22 & MD-23 important for the medical devices?

The importance of Form MD-22 is given below:

1. Ensures safety and reliability – Giving form MD-22 is known to be a mandatory requirement in India because it is used for establishing that the medical devices that are investigational are safe and perform best before going for the approval of the market. 
2. For novel devices – This is basically used for the devices that are totally new or do not have a “predicate” device, allowing for the evaluation of these innovative devices. 
3. Due to the strict regulatory process –  The form MD-22 is known to be a main part of clinical investigation approval. It is governed by the Indian Medical Device Rules, 2017, and overseen by the Central Drugs Standard and Control Organisation (CDSCO).
4. Promotes Ethical Standards – The form application process is the required evidence of ethics committee approval and also includes data from safety, performance, and biocompatibility tests, ensuring ethical standards are maintained. 

The importance of Form MD-23 is given below:

1. Grants Permission – This form, MD-23, is mainly used for providing authorization to manufacturers or importers to start the human trial for the new or investigational medical device in India.  
2. Ensures Regulatory Compliance – The Form also provides you with confirmation that the device and its clinical investigations can meet the requirements of the Medical Devices Rules, 2017, which is important for safety standards. 
3. Facilitates Market Access – When you get the authorized permission, the sponsor proceeds with your necessary testing by gathering data that supports approvals from the regulatory making your market access broader in the future. 
4. Protects patient safety –  The process of reviewing can lead to the issuance of Form MD-23 ensures human participants that the medical devices that are present in the clinic are totally safe and appropriate for investigation. 

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Process of getting MD-22 and MD-23 in India 

Form MD-22: To get the permission of Form MD-22, firstly, you have to submit an application on the CDSCO’s SUGAM portal, with all the documents that are required by the authority and the fees for conducting the clinical investigation for your new medical devices. This also includes the preparation of your application and the investigation of your clinic as per the Medical Device Rules, 2017.

Below are detailed instructions for completing Form MD-22:

1. Submit the application – Get the application form MD-22 from the CDSCO registration online, fill out or complete the application for your permission for clinical investigation. 
2. Documents and fees – Submit the required documents, which are required by the authority, along with your clinical investigation plan, Ethics Committee approval, and other relevant documents. Then, pay the fees that are required by the portal as per the Second Schedule of the Medical Device Rules, 2017. 
3. Regulatory and investigation – After which the CDSCO will review your application and the documents that are submitted by you. Then register for the trial of your clinic, which is mandatory before enrolling the first participant. 

Form MD-23: This involves submitting an application for the Form MD-22 to the CDSCO registration in India through the SUGAM portal because the Form MD-23 is a subsequent document that is digitally signed by CLA. The applicant must have to get approval from the  Ethics Committee and also register the clinic investigation with the  Clinical Trial Registry – India (CTRI) before doing the investigation.

Below are detailed instructions for completing Form MD-23:

1. Registration and inquiry – First, create an account on the SUGAM site using your information. Then plan your clinic investigation with the  ISO 14155 or Good Clinical Practice (GCP) guidelines. Collects the documents that are required by the CDSCO registration in India, which include a manufacturing license, a Free Sale Certificate, and device-specific files. 
2. Submit Form MD-22 – Also include Form MD-22 in your application that you are going to submit for requesting the investigation of your clinic. Upload all of the documents that are required on the SUGAM portal. Pay the fees and submit the application for review by the CLA. 
3. Grant of your permission: When the CLA is satisfied with your documents and your requirements, they give you permission for your clinical investigation through issuing the Form MD-23.
4. Commence Clinical Investigation – Register for your clinical investigation through the Clinical Trial Registry – India (CTRI). Done your clinical investigation by participating as the first participant within one year of receiving your Form MD-23 or otherwise, you have to get further permissions from the CLA, which is mandatory. 

Final words

The MD-22 and MD-23 Forms are typically different from each other; one is used for obtaining permissions from the CDSCO in India for the Clinical investigation, and the other is used for granting permission from the CDSCO online in India for the Clinical investigation. If you want an investigation of your clinic, then you have to permit both Forms one by one to obtain permission for the investigation of your clinic for new medical devices. 

This is mandatory for ensuring that the items in your clinic, like medical tools or devices, are safe and clinically proven for usage. The process for filling these forms is also not very hard. It’s an easy process through the CDSCO’s online portal, which makes it easier for manufacturers and importers, too.