Manufacturer license is essential in any country for the manufacturing of any goods. And If you are working in the medical sector then it is essential to have a manufacturer registration license. Because the medical sector relates to people’s lives and it is requisite for the government to ensure. So, If you are working in the manufacturing of medical devices or products then apply for manufacturer enrollment now. We are here to help you discover all the queries you have during medical device manufacturer license registration.
CDSCO Medical Device Manufacturing License
CDSCO stands for the Central Drugs Standards Control Organization. It is a well-named regulatory body that keeps an eye on the production of authorized medical devices. CDSCO has all the rights of approving and issuing the license to the manufacturer for medical devices. In the Medical Device Rules of 2017, Medical Device Manufacturing license problems are mentioned.
When you apply for the medical device manufacturer registration you have to follow a strict procedure. The rules of procedure are set under the Central Drugs Standards Control Organization.
Any of the new medical device rules is introduced & administrated by the central government & the state government. The CDSCO registration works is done under the state government due to the change the in the rules according to state.
What Is a Medical Device Manufacturer Registration License?
A Medical Device Manufacturer Registration License is a document issued by the government. It is an approval of products of any class of goods related to medical devices or Industry.
If you are willing to apply medical device manufacturer license then have to follow a particular processor for any class of medical devices. Before manufacturing, the applicant must apply for the medical device manufacturing registration license to sell and distribute goods in the market.
The applicant can apply for manufacturer registration through the online portals of the Ministry of Health & Family Welfare.
According to the product classes you have to fill out the form of application. License for class A & B Forms MD-3 and MD-5 are used. In these forms, you have to mention manufacturer information in the MD-3 form and In MD-5 you have to submit all necessary documents.
For the class C & D, you have to fill in the form MD-7 and MD-9 to obtain the license. MD – 7 form is used for the permission for the sale & distribution of medical devices to manufacturers. And MD-9 is formed for the license for the same.
Authorities Issue Medical Device Manufacturer Registration License
When you apply for the manufacture registration license then you have to tackle with these authorities:-
Central Licensing Authorities (CLA)
These central drug authorities in India are called as Central Drug Control Organisation (CDSCO) which is headquartered in Delhi – FDA Bhawan under the aegis of the Ministry of Health and Family Welfare. The CDSCO is responsible for the legislation of laws concerning drugs, cosmetics, and medical devices. The clinical trial of the drug and clinical investigation of medical devices is under the complete regulation of CDSCO. The FDA medical device import registration is regulated by CDSCO.
State Licensing Authorities (SLA)
The State Drug Control Authorities, which the State Governments appoint, are primarily responsible for regulating the sale, manufacture, and distribution of medical devices. Obtaining a Medical Device CDSCO Import License in India is primarily intended to ensure the availability of safe, effective, and high-quality medical devices that are found in scientific excellence and the best-conducting audits.
Central Licensing Authorities (CLA) V/S State FDA- State Licensing Authorities (SLA)
- Central Licensing Authorities (CLA)
- State Licensing Authorities (SLA)
- Import of all classes of IVDs.
- Manufacture of Class C and D Class D IVDs.
- Clinical performance evaluation and approval of new In-Vitro diagnostic.
- Registration of Notified bodies.
- Registration of laboratories for carrying out tests or evaluation.
- Manufacture for sale or distribution of Class A and Class B IVDs.
- Sales, Stock, Exhibit or offer for sale or distribution if IVDs of all Classes.
Manufacturing License For Medical Devices Manufactured In India
The Medical Devices (Amendment) Rules, 2020, published by the Government of India on February 11, 2020, set forth a new definition for all medical devices manufactured in India. Because of, significant notifications, which had taken effect on April 1, 2020, all medical devices must now be purchased with the assurance of the highest quality and safety standards.
All the medical devices that are manufactured across India must be registered under the guidelines mentioned by the Central Drug Standard Control Organization (CDSCO).
License for manufacturing Medical devices including in-vitro diagnosis devices are issued on the CDSCO portal. The licensing authority of class A (sterile and measuring) and class B medical devices is the state licensing authority. The licensing authority of the class C and D products is the central licensing authority.
Before the application for registration, medical devices must be appropriately classified according to the risk involved.
Process Of Registration For Manufacturing Medical Device
For the manufacturer registration license just follow the below-mentioned process:-
Step 1 – Fill & Submit The Application
The application must be submitted online and this is also known as the MD-12 test license. For all product classifications i.e. class a, class b, Class C, and class d: application for a test license in MD-12 is mandatory to apply for the final manufacturing license.
The list of documents required for the application for test license MD-12 is mentioned below :-
- Covering letter
- Constitution of the firm
- The Establishment/Site Ownership/Tenancy Agreement.
- Duly notarized copies of Quality Certificate in respect of manufacturing sites (s).
- Copy of Certificate supporting quality management system (ISO: 13485), if any
- Plant Master file from the Manufacturer as specified in Appendix I of Fourth Schedule of Medical Device Rules.
- Device Master File from the Manufacturer as specified in Appendix II (only for Medical Devices) of Fourth Schedule of Medical Device Rules.
- Test License obtained for testing and generation of quality control data.
- Undertaking signs stating that the manufacturing site is in compliance with the provision of the fifth schedule.
- Fee Challan
- Legal Form (Digital Sign Mandatory)
Step 2 – Wait For Approval
After the application of the test license application, wait for its approval. In case the quarry is raised against any of the above mentioned list of documents it must be answered provided with appropriate documents.
Step 3 – License Granted
After the whole procedure of query handling the test license is granted in MD-13.
Step 4 – Documentation Of Final Application
Applicants should be ready for the documentation for the final application for a manufacturing license. In the case of class a, and class b, apply in Md-3, and the license will be granted in Md-5 for classes C and D apply in Md-7 and get the grant in MD-9.
List of Necessary Filling For MDR Manufacturing License
Mentioned are the necessary filing for the approval of the manufacturer’s medical device license in India.
A quality management system is a research and diagnostic that covers all aspects of design, manufacturing, clinical data, risk management, and more. QMS is a type of tool. Increasing the standard for products, related services, and laws is the aim of the QMS. The ISO 13485 certificate requirements and the US FDA’s Quality system regulation should both be taken.
Plant Master File
The Plant Master File (PMF) annexes must be submitted in both hardcopy and digital form. Layout of the premises, Manufacturing activities, Total Employees, and Organization Chart should all be included in a PMF.
A certificate of plant registration or approval from NRA An details of the site’s relationship etc.
Location & floor plan of the premises.
A brief description of the main manufacturing and quality control laboratories’ equipment.
A chart sheet, all description of the manufacturing process and the quality control system Documentation for the System of Conformity used in Manufacturing.
Device Master File
Your medical device company is required by foreign regulatory agencies to maintain all records and specifications documents to the entire life cycle of every medical device manufacturing.
- Description of the device, product details, and a flowchart showing how the device is manufactured.
- An analysis of the proposed device with an exactly equal one that has been approved in India, as well as quality control reports on the raw materials and finished device, sterilization reports, etc.
- Clinical Investigation report/new literature and Biocompatibility Reports, biological reports.
- Test parameters and testing procedures Certificates of Analysis for the finished product and minimum 3 batch release devices certificate.
- Labeling, Draft Labels, Accelerated and Real-Time Management of Stability Study, Packaging Instructions, and Risk Assessment Analysis Reports are on the important basic checklist for foreign agency.
How Much Does Manufacturer Registration Cost & Validity?
The CDSCO Medical Device Manufacturer registration cost & validity varies according to the class of products. You will find each of them below:-
CDSCO Medical Device Manufacturing Validity And Fee (Class A And B)
CDSCO medical device manufacturing registration is valid for 5 years. The government fee is 5000 INR for each applicant, and 500 INR for each class A and class B medical device from the state licensing authority to audit all documents and industry proper goods then issue a license within 5 to 7 months.
CDSCO Medical Devices Manufacturing Validity And Fee (Class C And D )
CDSCO medical device manufacturing registration is valid for 5 years & government fee of 50000 INR for each applicant, and 1000 INR for each class A and class B medical device from the state licensing authority to audit all documents and industry proper goods then issue a license within 5 to 7 months.
Conclusion – Medical Device Manufacturer License
For all the manufacturers of medical devices, it is very necessary to get a license. With this you can regulate the medical devices easily. This will ensure the state government that you are manufacturing best product for the users. The certificate ensures that you are making all the effeorts to satisfy their customers.