CDSCO
New Medical Devices – The lifeline of Healthcare Industry
CliniExperts manages all regulatory and compliance mandates seamlessly
However, obtaining the required licences, certifications, and approvals for these devices is a herculean undertaking. More than 40 specific documents, covering 12 different factors, must be filed just for the plant master file. Additionally, there is the equally lengthy Device Master File, SUGAM portal registration, ISO 13485 certification, Clinical Performance Evaluation, and a seemingly infinite list of other regulatory requirements.
That’s not all. A new licensing regime for these devices comes into effect from 01-10-2023.
About Regulatory Body
Strict procedures must be followed in accordance with the norms and guidelines established by the Central Drug Standard Control Organization while manufacturing new medical devices (CDSCO). A process of applying for a license to sell or distribute medical devices is also required of applicants who intend to create new medical devices.
To get an import/manufacturing license for the sale/distribution of a new medical device, the importer/manufacturer must submit an application to the Central Licensing Authority/State Licensing Authority. The applicant for an import license must apply through an authorized agent who has a wholesale or manufacturing license for the distribution or sale of medical devices.
The Central Licensing Authority should be contacted via an online portal of the Ministry of Health and Family Welfare of Central Government. Once the application is submitted, the Central Licensing Authority will issue the approval in Form MD-27.
About New Medical Device
All devices consisting of an instrument, apparatus, implant, or another article, doesn’t matter used alone or in combination, containing software or an accessory, designed by the manufacturer for intended use on human beings or animals by any pharmacological or immunological, but it may help in its expected functions including diagnosis, prevention, monitoring, treatment, replacement or alleviation of any disease or disorder, injury or disability, and control of conception.
Non-Notified Medical Product registration is required for any Medical Device that does not fall within the 37 Notified Medical Devices.
How It Is Regulated?
The licensing authority in India is the Central Standard Control Organisation (CDSCO). The licensing process in a nutshell.
A new medical device whose similar or predicate is not available in India, or any other existing medical device with a change in design or intended use, needs to demonstrate their safety before applying for the license.
In this accord, a clinical investigation has to be conducted on human participants to evaluate the effectiveness and safety of the medical device.
Once the clinical investigation has been completed and the device is regarded safe, an application for the import or manufacture of this new investigational medical device can be filed with the Central Licensing Authority (CLA).
Why to get manufacturing License before 1st October, 2022
In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class A & Class B categories are scheduled to enter licensing regime with effect from 01.10.2022 A transition period of 30 months had been provided for Class A & Class B medical devices from the date of implementation of G.S.R. 102(E) i.e. 01.04.2020 for the transition to the licensing regime.
So now it is advised that all manufacturers shall apply for obtaining a manufacturing license for Class A & Class B medical devices through COSCO`s online portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per the stipulated time.
CliniExperts Can Assist In
The importer or manufacturer must submit an application to the Central Licensing Authority in order to get an import/manufacturing licence for the sale or distribution of a new medical device.
An authorised agent with a wholesale or manufacturing licence for the distribution or sale of medical devices must submit the application on behalf of the licencing applicant for an import.
Fulfilment of these requirements is an experienced expert’s task. In-house attempts often result in waste of time, money, and resources. Ciliniexperts, the regulatory experts, can handle it effortlessly.
Form Names: MD-22, 23
Conduct clinical investigation
The objective of clinical investigation of medical products is to collect information to assess the quality and safety of medical products concerning their intended purposes. This is done to determine the possibility of adverse consequences or dangers associated with the product. Similar to the approval process for medications, the clinical study of the medical device is crucial to use either on or by humans to test and evaluate the effectiveness, performance, and security of medical devices.
Regulatory Body Requirement
The manufacturers and importers who wish to carry out a clinical investigation of an investigational medical device should obtain permission from the CLA, which can be done through an online application process.
How to Apply
The manufacturer or importer who intends to conduct a clinical investigation of medical devices can apply via the following procedure:
- The application for grant of permission to conduct a clinical investigation of an investigational Medical Device can be made in Form MD-22
- The application should address the Central Licensing Authority of India and the Central Drugs Standard and Control Organisation.
- The application should be submitted with the required documents and the application fees on the SUGAM portal.
Form Names: MD-26, 27
New Medical Device permission
To get an import/manufacturing license for the sale/distribution of a medical device that does not have a predicate medical device, the Importer/Manufacturer must make an application to the Central Licensing Authority. The Import license applicant must do this via an authorized agent having a manufacturing or wholesale license for the sale or distribution of medical devices. The application should be made to the Central Licensing Authority via an online portal of the Ministry of Health and Family Welfare in the Central Government using Form MD-26 and the permission is received in the Form MD-27.
It is the responsibility of an experienced professional to fulfil these standards. Attempts made internally frequently waste time, money, and resources. The regulatory professionals at CliniExperts can manage it with ease.
Regulatory Body Requirement
As per the provisions of Medical Device Rules, 2017, notified medical devices which need to be imported/manufactured in India, which does not have a predicate medical device, will be required to make an application using FORM MD-26. FORM MD-26 is necessary to grant permission for importing/manufacturing these medical devices. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants the permission to import or manufacture new medical device in India- Form MD 26 & 27
How to Apply
- STEP 1: Evaluation of the product, if it requires registrations as per MDR 2017
- STEP 2: If requires registration, Evaluation of classification (Class A…….)based on the product risk category
- STEP 3: Preparation of documents as per the MD 26 checklist
- STEP 4: Appoint Authorized agent in case of Import of the product
- STEP 5: Online generation of application
- STEP 6: Before submission of application, approval/confirmation of draft application by the authorize agent/manufacturer
- STEP 7: Follow-up with regulatory authority
Form Names: N/A
SUGAM Registration- MD/ IVD
Under the ambitious Digital India initiative, the Ministry of Health and Family Welfare has established the versatile and efficient SUGAM portal. With its 3600 tracking, querying, upload/download, and many other useful features, the SUGAM interface facilitates digital processing of almost all requirements related with Class A and B medical devices. Cliniexperts’ thorough knowledge of this portal can speed up these processes in a ZERO-ERROR digital environment.
Regulatory Body Requirement
The registration process for medical devices is primarily done on the SUGAM portal, a website where the applicants apply for approval of licenses, FSC and Registration numbers. In addition, the portal provides an interface and ease of access for applicants to track the submitted application, query responses and the ability to download permissions issued by the CDSCO.
Any applications submitted are reviewed and approved/rejected by the CDSCO. The process involves the submission of necessary documents on the online portal. After uploading the documents, applicants must submit a hard copy of the papers to the CDSCO (Medical Device Division) for further approval on the medical device portal.
How to Apply
- Step 1: An applicant (manufacturer/importer) requires a user login id with the credential to apply on the SUGAM portal (https://cdscomdonline.gov.in/NewMedDev/Homepage).
- Step 2: The registration requires uploading all the self-attested copies of the undertaking (the documents which include the name and address of the Company and issued by the Government Authority).
- Step 3: The applicant also has to upload Aadhar ID proof (Authorised person/agent), the manufacturing license or Wholesale Drug License and the certificate of incorporation.
- Step 4: After online registration, the applicant must submit hard copies of all the uploaded documents and the Cover Letter to the CDSCO for verification. The CDSCO will approve the Sugam Registration after evaluating the proposed application and the documents.
Form Names: MD12, MD13
Test license to Manufacture Medical Devices (Form MD 12, 13)
Medical Devices must establish a stringent product testing regime. Apart from a vast range of testing parameters including testing on different software, this regime also includes a strict compliance protocol. Once test licence is obtained permission for manufacturing is required.
Once all these parameters are established, an application to procure a test license has to be submitted on Form MD-12, and the permission is granted on Form MD-13.
Fulfilment of these requirements is an experienced expert’s task. In-house attempts often result in waste of time, money, and resources. CliniExperts, the regulatory experts, can handle it effortlessly.
Regulatory Body Requirement
In India, small quantities of Class A, Class B, Class C, or Class D medical devices may be manufactured by procuring a Test License in Form MD-13 issued by CDSCO. These devices can be used for the purpose of clinical research, testing, evaluation, demonstration, or training.
A person who intends to manufacture a medical device must apply for a Test license by filling out a Form MD-12 from an identified online portal of the Ministry of Health and Family Welfare for the purpose of test, evaluation, demonstration, and training. The Ministry of Health and Family Welfare will then issue a Test license in the Form MD-13.
How to Apply
The application is done with reference to MDR 2017. Registration on the Sugam portal is mandatory for applying for the test license
- Step 1: Register the applicant on Sugam portal
- Step 2: Draft application
- Step 3: Upload mandatory documents as per check list of MD-12
- Step 4: Payment of Requisite government fee
- Step 5: Submit the application on online medical device portal
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