CDSCO
Medical Devices Class C & D – The lifeline of Healthcare Industry
CliniExperts manages all regulatory and compliance mandates seamlessly
However, procuring the necessary approvals, licenses, and certifications for these devices is a Herculean task. Just the plant master file requires filing of over 40 detailed documents spread over 12 different parameters. Then there is the equally exhaustive device master file to take care of, registration on SUGAM portal, ISO 13485 certification… the regulatory mandates are seemingly endless!
That’s not all. A new licensing regime for these devices comes into effect from 01-10-2023.
About Regulatory Body
Manufacturing Medical Devices requires stringent processes to be completed under the laid down rules and regulations by Central Drug Standard Control Organisation (CDSCO). In addition, applicants who intend to manufacture Class C or Class D Medical Devices have to go through a procedure by applying for a license to sell or distribute Medical Devices. The CDSCO ensures quality and safety of medical devices sold in the market in this manner.
Such applicants have to apply to the Central Licensing Authority (CDSCO) for approval from the Ministry of Health and Family Welfare's online portal, depending on the applicant's location. An application has to be submitted in FORM MD-7 along with necessary documents for procuring a license as FORM MD-9.
About Class C and D Medical Device
As per the New Medical Rules, 2017, all medical devices have been classified into four distinct classes. According to the MDR, the categories are Class A, Class B and Class C, and Class D. Any business that intends to create these devices for distribution or sales must apply to CDSCO to obtain a manufacturer`s license.
Devices classified under Class C or Class D are classified as Moderate high risk and High risk. The application to manufacture these medical devices is required to be made at the Central Licensing Authority.
Manufacturing license applications are created using Form MD-7. Form MD-9 is the authorization to produce class C or Class D medical device products that are available for distribution or sale. Form MD-7 can be used for submitting an application for a permit for the manufacture of class C or Class D medical devices that are available for sale and distribution, as well as Form MD-9, which is used to get the manufacturing license for medical devices of Class C as well as Class D medical equipment.
How It Is Regulated?
The licensing authority in India is the Central Standard Control Organisation (CDSCO). The licensing process in a nutshell:
Fill up the exhaustive application Form MD-7 and upload it on the SUGAM port
Central licensing authorities issue permission to manufacture Class C and D devices on Form MD-9 after a grueling evaluation process.
Why to get manufacturing License before 1st October, 2023
In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class C & Class D categories are scheduled to enter licensing regime with effect from 01.10.2023. A transition period of 30 months had been provided for Class C & Class D 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 C & Class D medical devices through COSCO`s online portal so that the manufacturing license can be granted by respective Central Licensing Authorities after review of the applications and audit (as the case may be) as per the stipulated time.
CliniExperts Can Assist In
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 license 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. Ciliniexperts, the regulatory experts, can handle it effortlessly.
Form Names: MD7, MD9
Permission to Manufacture Class C-D Medical Devices
The Central Drugs Standard Control Organization is the top Indian regulator that supervises the manufacture and distribution of accepted medical equipment (CDCSO). In India, the regulatory authority is responsible for granting licenses and approving the manufacturing and use of medical equipment. FORM MD-7, along with FORM MD-9, are utilized by this agency to issue manufacturing permits in accordance with the Medical Device Rules of 2017.
Regulatory Body Requirement
The highest Indian regulatory body supervising the manufacturing of notified medical devices is the Central Drugs Standard Control Organisation (CDCSO). In India, the regulatory authority is responsible for giving license and approval for the manufacturing of medical devices. This regulatory authority provides the manufacturing licenses in Form MD-9 which is required as per the provision of Medical Device Rules, 2017.
An application needs to be submitted to the Central Licensing Authority for a manufacturer license. This can be applied through the online portal of the Central Government. A manufacturer license allows the sale or distribution of Class C and Class D medical devices in Form MD-9 which is obtained by applying via Form MD-7.
How to Apply
A manufacturer must apply for a Grant of License to manufacture for Sale and distribution Class C or Class D medical devices
- Step 1: Application can be made to the Central Licensing Authority in Form MD-7
- Step 2: The application requires the following documents:
- Cover letter, plant master file and device master file
- Quality Management System specified as per the 5th schedule of Medical Device Rules and performance evaluation report (IVDs only)
- Constitution detail of the firm, the establishment/site ownership/tenancy Agreement
- Valid Test License obtained for testing and generation of quality control data
- Singed undertaking stating that the manufacturing site is following provisions of the Fifth schedule.
The application is reviewed by the CDSCO. An inspection of the manufacturing site might be conducted by a Notified body or by Medical Device Officers, with or without an expert. Basis this, the CDSCO may decide to issue the valid license in Form MD-9.
Form Names: N/A
Medical Device ISO 13485 Certification Assistance
From design, to R&D, testing, manufacturing, sales and distribution, storage, and end-usage – Medical device lifecycles are increasingly controlled by regulatory and compliance mandates. ISO-13485 is designed to ensure the safety, effectiveness, and accuracy of these devices at the user end. Hence, being ISO-13485 certified is critical for all stakeholders – Be it the designers, manufacturers, suppliers, service providers, or distributors.
CliniExperts has long-standing experience to undertake end-to-end fulfilment of ISO-13485 process. Our in-house experts, in collaboration with the registered process facilitators and auditors, offer best-in-class services for a smooth and hassle-free ISO-13485 certification.
Regulatory Body Requirement
ISO 13485 Certification provides a comprehensive framework for medical device designers, manufacturers, suppliers, service providers, and distributors to assure quality, safety, and regulatory compliance. ISO 13485 is a distinctive QMS (Quality Management System) standard evolved from the globally recognized standard - ISO 9000.
ISO 13485 Certification implies that a company has met all the requirements and has effectively implemented an ISO 13485 QMS focusing on the efficacy and safety of medical devices. The certification follows the PDCA framework wherein the applicant must establish and implement quality management in accordance with the ISO 13485 standard. Following the implementation of the QMS, the applicant needs to approach an accredited notified body for the audit of the organization. The accredited notified body performs an audit to assure that the firm can continuously meet and sustain quality standards and issue the certification.
Usually, it takes around 6-9 months to complete the ISO certification process.
How to Apply
- Define the scope of the ISO 13485 Certificate Initially, it is necessary to envision the objectives of your organization and the scope for the certification.
- Select notified body
- Establish QMS and prepare necessary documents.
- Implement the PDCA cycle and work in accordance with your QMS.
- Prepare and optimize audit
- Conduct Internal and pre-assessment audit
- Proceed for a certification audit by a notified body. The notified body will audit your company for two to ten (or even more) days depending on the size of your organization. Finally, the notified body will issue the certificate(s) if the organization passes the audit successfully.
Form Names: MD4, MD6
Permission for Loan License to Manufacture Class C - D Medical Devices
Financial constraints can prevent you from achieving the success that your business deserves. A loan for manufacturing new notified medical devices of Class C and Class D, or for increasing the scale of production of your existing notified medical devices can help you soar to new heights. Contact CliniExperts today to help you sail through the paperwork and obtain the Loan License for Manufacturing of Class C and Class D notified medical devices via Form MD – 8 and Form MD – 10 in no time!
Regulatory Body Requirement
According to the Medical Devices Rules, 2017, a loan manufacturing license in Form MD-10 is required for loan manufacturing of Class C & D (Notified) medical devices in India. These loan license applications are filed in Form MD-8, which is used to obtain the licenses in Form MD-10.
In order to obtain a loan license to manufacture Class C & Class D medical devices, the manufacturer has to make an application to the Central Licensing Authority via an online portal of the Central Government. It takes between 4-5 months to complete the process.
How to Apply
- Step 1: Sugam Registration of the applicant
- Step 2: Drafting the Application
- Step 3: Uploading all the documents according to checklist of the form MD-8
- Step 4: Processing of the mandatory government fee
- Step 5: Submitting the application on online Medical Device portal
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: Applicant registration on the Sugam portal
- Step 2: Draft application
- Step 3: Upload required documents as per the checklist of MD 12
- Step 4: Payment of requisite government fee
- Step 5: Application Submission
- Step 6: Query address and license approval
- Step 7: Post approval activities
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