Strict procedures must be followed in accordance with the rules and guidelines established by the Central Drug Standard Control Organization (CDSCO) when manufacturing medical devices. Additionally, candidates must go through a process by submitting an application for a licence to sell or distribute medical devices if they want to manufacture Class A or Class B medical devices. Medical devices traded in this way on the market are of a high standard and secure. Based on the applicant’s location, such applicants must submit an application for consent to the State Licensing Authority via the Ministry of Health and Family Welfare’s online portal. Form MD-3 and Form MD-5 are used for the purpose of obtaining a licence; an application in FORM MD-3 must be submitted along with the required paperwork in FORM MD-5.
The State Licensing Authority regulates the Manufacturing License for the sales and distribution of Class A and Class B In-Vitro Diagnostic Kits. The manufacturing business must submit its application to the state drug control agency, whose jurisdiction includes the manufacturing facility. When applying for a licence to manufacture IVDs, the company must submit to the SLA all necessary technical and administrative documents.
Form MD-3 and Form MD-5 – Meaning
Form MD-3 and Form MD-5 are required to obtain permission to manufacture Class A-B medical devices in India.
Form MD-3 is an application form for the grant of a License to manufacture, sell/distribute a Class A/Class B Medical Device. On the other hand, License MD-5 is the grant of a License to manufacture, sell, or distribute a Class A or B medical device by CDSCO after review of all documents and approval of those documents.
Who Is Eligible to Apply?
Form MD-3 and FORM MD-5 allow manufacturers to apply for a permit to manufacture Class A or Class B medical devices.
How Should One Apply?
For the purpose of selling, manufacturing or distributing medical devices, a manufacturer needs to submit an application to the State Licensing Authority using the FORM MD-3. Both Form MD-3 and Form MD-5 are used to obtain a license to manufacture Medical Devices. Additionally to the FORM MD-3, you will need to submit the items on the required documentation list.
Essential Documents Required for filing the Application
According to the CDSCO, the following are among the documents that must accompany the application:
- Device Master File
- Site Master File
- Documents Relating to Quality Management Systems.
The following documents must be submitted along with the application form:
1. Cover Letter
2. Application form
3. Challan for the receipt of fees
4. Organizational structure of the company, including:
- Partnership deed / Memorandum & Article of Association
- Declaration of the Owner(s), Partners, Director(s), and Managing Director of the Company
- A complete list of all partners and directors, including their ages and full postal and residential addresses.
5. Documents relating to the ownership of the site and the tenancy agreement
6. Plant Master File (as according to appendix I of Part III of the fourth schedule) In addition to the information that is required according to Appendix I of Part III of the Fourth Schedule, the following documents are also required to be submitted:
- The Manufacturing Chemist’s Declaration
- Declaratory Statement of the Analytical Chemist.
- Documents of educational qualification, experience & approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id proof.
- Registration through the District Industries Centre
7. A Device Master File for each individual product (in accordance with the fourth schedule’s appendix II and Appendix III)
8. Report on the Evaluation of Performance (if applicable)
9. A copy of the driver’s licence test (if applicable).
10. A guarantee that the location where the product is manufactured complies with the requirements outlined in the Fifth Schedule.
Procedure to Follow in Order to Acquire a Manufacturing License for Medical Devices:
- Submission of an Application for the Granting of a Manufacturing License:
The applicant is required to submit an application in the required format, such as MD-3 (or MD-4 for loan license), online at the CDSCO portal (cdscomdonline.gov.in), in order for a licence to be issued on form MD-5 or as applicable according to the Medical Device Rules. The applicant must also submit the necessary fees challan, which can be found in the fee chart under the heading ‘Forms & Fees.’
- Examination of the application:
In the event that any deficiencies or inconsistencies are discovered, a query must be submitted. After receiving a response to the query from the applicant, the next step in the process will be taken. In the event that the application is deemed to be in proper order, it will be processed for factory premises audit by a notified body in accordance with the Medical Device Rules.
- Audit of the premises of the applicant by a notified body:
If there are any violations, the applicant is responsible for making the necessary corrections. The notified body is responsible for uploading both the audit report and the notification of closure.
- After the audit report has been received, it will be reviewed, and if it is determined to be adequate, it will be sent on to further stages.
- Evaluation of Goods and Services:
The specifics of the products that have been requested will be investigated, and if it is discovered that they are in accordance with the standards, the application will be taken into consideration for the granting of a licence.
- The Issuance of Permissions:
The granting of a licence is contingent on the fulfilment of all of the stipulated requirements.
Required paperwork for a loan licence (Form MD-4):
1. A letter of consent from the primary manufacturing unit in the event that a loan licence is required.
2. Retail licences held by the applicant for the wholesale licence.
3. Copies of the product’s permission to be sold along with valid manufacturing licences for the product in question, provided by the principal manufacturer of the product
Form MD-3 and Form MD-5 is used to obtain a manufacturing license for the intended In-Vitro Diagnostic Kits, and reagents in Class A and B. Form MD-4 is used to submit an application for a Loan License along with the prescribed fees. After that, the Manufacturing License for Class A&B IVD is obtained using Form MD-3 and Form MD-5, and the Loan License is obtained using Form MD-6.
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