Following are the frequently asked questions (FAQs) regarding medical device registration and regulations in India.
What is the process for registration of Medical Devices in India?
Check if Product Seeks Registration: In India, the manufacturing and distribution of medical devices are regulated.
Hire Authorized Indian Agent: The registration cannot be granted to someone who is not from the Indian territory.
Submission of the Dossier under Form 40: This is a crucial step in the registration process.
Avail Registration Certificate in Form 41: After the submission and approval of Form 40, the next step is to avail the Registration Certificate in Form 41.
Avail Import License in Form 10: If the medical device is to be imported, an Import License in Form 10 is required.
For Indian Manufacturers, they first need to obtain a Manufacturer License (Form MD-03 or MD-07), followed by Product Registration as per Form 40 for notified medical devices1. For Foreign Manufacturers, they need to apply for a Registration Certificate & Import License1. All applications are filed online via the SUGAM portal.
What is the new registration requirement for medical devices in India?
In 2020, the Indian Government brought about a change in law to the effect that manufacturers and importers of all medical devices have to meet certain requirements1. All medical devices that are manufactured in India or are imported into India have to either be licensed or registered by October 1, 20211. If a medical device is manufactured or imported after October 1, 2021 without registration or license, it will be deemed to have been manufactured or imported in violation of Indian law, thereby inviting penal action.
As per the Medical Devices (Amendment) Rules, 2020, manufacturers and importers of all medical devices and equipment (with the exception of those that have been notified by the government) in India are required to register their medical devices in India before October 1, 20211. The government has given time to the medical device industry to register ‘voluntarily’ by October 1, 2021. After that, manufacturers and importers will have to ‘mandatorily’ register their medical devices and equipment in order to be able to manufacture in India or import medical devices into India.
What is the role of the Central Licensing Authority?
The Central Licensing Authority (CLA) in India plays a crucial role in the regulation of medical devices. Here are some of its responsibilities:
Overseeing Importation: The CLA oversees the importation of all classes of medical devices.
Regulating Manufacturing: The CLA is responsible for the manufacture of Class C and D medical devices.
Clinical Evaluation and Approval: The CLA is in charge of the clinical evaluation and approval of investigational medical devices and new In Vitro Diagnostics (IVDs).
Enforcing Rules: The CLA functions under the purview of the Drug Controller General of India (DCGI) and is the competent authority to enforce the rules that relate to importing all medical devices in India.
The CLA works under the Directorate General of Health Services, the Ministry of Health and Family Welfare, and the Government of India. It is also responsible for granting licenses to certain drugs and medical devices.
What are the fees and charges for medical device registration in India?
The fees and charges for medical device registration in India are as follows:
The CDSCO approved fee for the registration of a single medical device in India is USD 1000.
The fee for a single manufacturing site is USD 1500.
An additional fee of USD 1000 for each additional medical device shall be paid if necessary2.
For Class A medical device other than in vitro diagnostic medical device, the import license fee for one site is USD 1000 and for each distinct medical device is USD 50.
For Class B medical device other than in vitro diagnostic medical device, the import license fee for one site is USD 2000 and for each distinct medical device is USD 1000.
What is the guidance on grouping of medical devices for product registration in India?
Grouping of medical devices for product registration in India is based on the Medical Device Rule (MDR) 2017 by the Indian Ministry of Health. The guidance for grouping helps simplify the application process, making it more cost-effective and saving the time of the person applying for the license to import, manufacture, sell, or distribute medical devices.
Medical devices are classified into 4 categories in accordance with MDR 2017 Guidance; from low-risk Class A to high-risk Class D2. The grouping of medical devices for product registration is a crucial aspect of the regulatory process.
How can companies ensure compliance with the new Indian Medical Devices Regulation?
Companies can ensure compliance with the new Indian Medical Devices Regulation by following these steps:
Adopting Global Medical Devices Nomenclature (GMDN) or Universal Medical Device Nomenclature System (UMDNS): These are internationally recognized nomenclature systems that help in the standardization and categorization of medical devices.
Using International Test Reports for Product Compliance: This helps in ensuring that the medical devices meet the necessary safety and performance requirements.
Enforcing Regulatory Compliances from the Design/Research Phase: This aids in the development and facilitates quicker approvals.
Creating a Single Window Clearance System for Licensing of Medical Devices: This helps in streamlining the licensing process.
Enhancing Standardization and Quality Compliance: This ensures that the medical devices meet the necessary quality standards.
Establishing Stronger Price Control Measures and a Uniform Code for Marketing of Medical Devices: This helps in controlling the prices of medical devices and ensures ethical marketing practices.
Strengthening Personal Health Data Security: This ensures the protection of patient data.
Adopting a National Nomenclature for Medical Devices: This helps in the standardization and categorization of medical devices.
What are the American National Standards Institute (ANSI) standards for medical devices?
The American National Standards Institute (ANSI) oversees standards and conformity assessment activities in the United States. ANSI, in conjunction with the Association for the Advancement of Medical Instrumentation (AAMI), has been at the forefront in developing voluntary consensus standards, technical information reports, and other technical documents. These standards are used throughout the healthcare field to ensure the safe and effective production, distribution, and use of health technology.
One of the key ANSI/AAMI standards for medical devices is ANSI/AAMI/ISO 14971:2019. This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The procedures used by AAMI to develop American National Standards meet ANSI’s essential requirements for openness, balance, consensus, and due process. AAMI also administers numerous international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and is accredited by ANSI to administer U.S. Technical Advisory Groups that develop and coordinate U.S. positions on ISO and IEC standardization activities.
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