Apply For Manufacturer Registration In India

Apply For Manufacturer Registration In India

Role Of Central FDA- 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 ministry of health and family welfare. The CDSCO is responsible for the legislation of laws with respect to drugs, cosmetics and medical devices.The clinical trial of the drug and clinical investigation of medical devices is under the complete regulation of CDSCO . TheFDA medical device import registration is regulated by CDSCO.

Role Of State FDA- State Licensing Authorities (SLA)

The State Drug Control Authorities, which are appointed by the State Governments, are primarily responsible for regulating the sale, manufacture, and distribution of medical devices.Obtaining a Medical Device 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 FDA- 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 Licence 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. As a result 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 which are manufactured across India must be registered under the guidelines mentioned by the Central drug standard control organisation (CDSCo).
Licences 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.

Medical Devices Classification Table

Table -1

Process Of Registration For Manufacturing Medical Device


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 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, sterilisation 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.

  • Labelling, 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.

CDSCO Medical Device Manufacturing Validity And Fee (Class A And B)

CDSCO medical device manufacturing registration is valid for 5 years & government fee of 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 licence 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 licence within 5 to 7 months.

Loan Licence

A loan licence is given by the third party’s manufacturer. When manufacturing medical devices, you will require a loan licence or a contact loan licence because there is a distinction between an agreement and a contract. The words “marketed by” and “manufactured by,” along with the manufacturer’s name and address, will be printed from under the label of the marketing company.It is the process of starting to manufacture medical devices in private facilities that have been rented.

Newly Manufactured Medical Devices Needs To Be Registered Under CDSCO

When applying for registration under the Drug and Cosmetics Act 1940 and rules 1945, manufacturers of new medical devices must first ensure patient safety, efficacy, and protection. Manufacturing of medical devices is done with the aim of acquiring information on efficacy, cohort studies, and safety and stability. Forms MD-26 grant MD-27 must be filled out after registration. Medical devices are then authorised by the central licensing authority(CDSCo).

Clinical Investigation Of Newly Manufactured Medical Devices

According to the CDSCO Ministry of Health and Family Welfare Medical Device Rule 2017, new medical device research must be registered to conduct clinical investigations of medical devices to evaluate their stability, potency, effectiveness, and safety. A clinical investigation is then conducted. In order to manufacture, sell, and distribute novel medical devices to the market’s, applicants must submit an application for the MD-22 grant MD-23.

Table -2