Medical devices and IVDs are regulated & controlled by the Drug Controller General of India, also known as DCGI, which operates under the Central Drugs Standard Control Organization (CDSCO)[1]. CDSCO is a part of the Ministry of Health and Family Welfare. The rules and Regulations of Medical devices are based on Medical Device Rules, 2017. Not all Medical Devices and IVDs are required to be registered in India; there is a limited list of Medical devices and IVDs that are to be essentially registered in India.
In-Vitro Diagnostics – Meaning
In-Vitro Diagnostics or IVDs are medical devices and tools used for the purpose of testing samples like blood, urine, and tissues which are taken from the human body in order to detect infections or a medical condition, or to prevent any disease, etc.
IVDs are the tools used outside the human Body to find out any abnormality, disease or disorder. The list of IVDs is mentioned in section 3(b) (i) of the Drugs and the Cosmetics Acts, 1940. Section 3 (b) (iv) of The Drugs & Cosmetics Acts, 1940 covers the IVDs that are notified from time to time.
Medical Devices – Meaning
Medical devices are the tools, articles or materials which are made to be used on human beings for the purpose of prevention, diagnosis, monitoring, and treatment of diseases or any Injury or physical disorder. These are also used for the process of investigation, replacement or modification of anatomical or physiological process for the purpose of controlling any conception that does not meets its goals through pharmacological, immunological or metabolic means.
CLA and SLA Regulations in Medical Devices and IVD
The Central Drug Standard Control Organization (CDSCO) authorizes Central Licensing Authority (CLA) and State Licensing Authority (SLA) in order to maintain laws and regulations on the Import, export, Licensing, registration, manufacture, marketing etc. of Drugs, Medical Devices and IVDs.
- CLA:
CLA is the Body that is responsible for the regulation of Import device licensing and manufacturing of Class C& D Medical Devices. CLA may also avail services of a notified body for the purpose of inspection of the manufacturing site of Class C and Class D medical devices. CLA is also responsible for regulating rules and procedures for IVDs. It regulated Imports of all classes of IVDs, along with the manufacture of Class C and Class D IVDs. CLA is responsible for the registration of Notified Medical devices and IVDs. It also approves new IVDs and evaluates their clinical performance and quality check-up. CLA grants registration of labs for performing the tests and regular evaluation. It also grants licenses for the purpose of manufacturing or importing all classes of IVDs.
- SLA:
The State Licensing Authority (SLA) is responsible for granting licenses for manufacturing, loans and wholesale of Class A & Class B Medical Devices. SLA authorizes a Notified Body to inspect the Quality Management System and Technical Review for manufacturers of Class A & B Medical Device. SLA makes and maintains rules and regulations for the purpose of manufacturing Medical Devices and for the sale or distribution of Class A or Class B IVD. It regulates the process of selling IVDs of all classes.
Difference between Medical devices and IVD
- Medical Devices:
“A Medical Device can be considered as any instrument, tool, apparatus, implement, machine, appliance, implant, and reagent for the purpose of in vitro use, software, material or any other related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.”
Earlier, there was no jurisdiction in the selling of Medical Devices by the manufacturers. They used to sell medical devices without any rule or law governing them. Later, as a policy of the FDA, Indian Medical Device Regulations were made by CDSCO, which made it necessary for the Import or Export of Medical Devices in India to be regulated. In India, only the notified medical devices need to be regulated by CDSCO. The registration certificate comes as Form-41, and the Import License comes as Form-10 as per the rules of the Drugs and Cosmetics Acts, 1940. There are 37 categories of devices that need to be regulated by CDSCO before being Imported, Exported or Sold in India. A different set of supporting documents is needed with every application form submitted to the CDSCO.
Time period and Validity of Registration of Medical Devices-
In India, after the manufacturer has completed submitting all the relevant documents and the registration/ license fees, the time period for the registration of Medical Devices is usually 6 to 9 months. The registration remains valid for three years. For the purpose of re-registration in case of expiry of the registration certificate, the renewal application for the registration should be submitted six months before the expiry.
- In vitro diagnostics (IVDs):
In vitro diagnostics (IVDs) are the devices that are used to detect diseases, infections and testing samples like blood, urine, and tissues which are taken from the human Body in order to detect infections or a medical condition, or to prevent any disease, etc. In- Vitro means “In Glass”, which means the tests are conducted in test tubes and similar glass equipment, whereas In-Vivo tests are conducted in the Body Itself.
IVD kits are divided into two types- Notified and Non-Notified IVDs. IVD kits/reagents are classified into two categories as Notified and Non-notified IVD products.
The Notified products are-
- In-Vitro Diagnostic Devices for HIV
- In-Vitro Diagnostic Devices for HBV
- In-Vitro Diagnostic Devices for HCV
- In-Vitro Blood grouping sera
For the purpose of registration of In Vitro Diagnostic Kits in India, Form-41 is required for the registration certificate of notified IVDs and Form-10 is required for the Non-Notified IVDs, as regulated by the Drugs and Cosmetics Rules. A Test License via Form-11 and the Performance Evaluation report is needed before the registration application of IVD products.
Time period and Validity of Registration of IVD:
In India, the validity of Form-11 for the purpose of test license is for one year unless the license is suspended or cancelled, whereas the Registration certificate OD IVDs is valid for three years.
Conclusion
The Indian market has been a huge attraction to the manufacturers of medical devices and IVDs. But there are challenges ahead for the regulatory Body in India, as it is at its Initial stage and the regulations and rules need to be amended and improved over time.
Read our Article:Medical Device and IVD Emergency in India
