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.
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.
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.
Application must be submitted online and this is also known as MD-12 test licence. For all product classification i.e class a, class b, class c, class d: application for test licence in MD-12 is mandatory to apply for final manufacturing licence.
List of document required for the application for test licence MD-12 are mentioned below :-
Applicants should be ready for the documentation for the final application for manufacturing licence. In case of class a, class b, apply in Md-3 and licence will be granted in Md-5 for class C and D apply in Md-7 and get the grant in MD-9.
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.
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 chart sheet, all description of the manufacturing process and the quality control system Documentation for the System of Conformity used in Manufacturing.
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 .
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 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.
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.
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).
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.
