Top Differences Between Medical Devices and IVDs – An Overview
Karan Singh | Updated: Oct 04, 2022 | Category: CDSCO
In India, Medical Devices and IVDs are regulated by DCGI (Drug Controller General of India) within CDSCO, which is an integral part of the Ministry of Health & Family Welfare. The regulatory framework for medical devices is totally based on the Medical Devices is based on MDR or Medical Device Rules, 2017. In India, only a limited no. of Medical Devices & IVDs require Registration. In this write-up, we will discuss the differences between Medical Devices and IVDs.
Table of Contents
Licensing Authorities for Medical Devices & IVDs in India
The CDSCO authorised SLA (State Licensing Authority) and CLA (Central Licensing Authority) in order to maintain regulations& laws on the Registration, import, export, marketing, licensing, etc., of Drugs, Medical Devices & IVDs.
- SLA (State Licensing Authority): SLA is responsible for issuing Licenses for manufacturing loans & wholesale of Class A and B Medical Devices. State Licensing Authority authorises notified body to inspect the QMS (Quality Management System) & Technical Review for manufacturers of Class A& Class B Medical Devices. SLA maintains & makes rules and regulations for the purpose of manufacturing Medical Devices and for the sale or distribution of Class A or B IVD and it regulates the process of selling IVDs of all classes.
- CLA (Central Licensing Authority): It’s the body that is responsible for the regulation of import device licensing & manufacturing of Class C & D Medical Devices. This Authority may also avail services of a notified body for the purpose of inspection of the manufacturing site of Class C & D Medical Devices. CLA is responsible for regulating rules & procedures for IVDs. It also regulates imports of all IVD classes along with the manufacture of Class C & D IVDs. It is responsible for the Registration of IVDs & Notified Medical Devices. It also approves new IVDs & evaluates their Clinical Performance & quality check-up. Central Licensing Authority grants Registration of labs for performing regular evaluations & tests. CLA grants licenses for the purpose of importing/manufacturing all classes of IVDs.
Comparison Table Between Medical Devices and IVDs
Following is the comparison table between Medical Devices and IVDs:
| Points | Medical Devices | IVDs |
| Definition | A Medical Device can be deemed as any instrument, apparatus, machine, tool, material or other article & accessories to such items (whether used alone/in combination for its proper application) as intended by the manufacturer to be used on humans for Diagnosis, monitoring, prevention, compensation or compensation for injury or handicap. Prevention, treatment, diagnosis, monitoring, or alleviation of diseases.Replacement, investigation, or modification of the anatomical or physiological process. Control of conception & that doesn’t achieve its intended purpose by means of pharmacological, metabolic, or immunological means, but that may be helped in its function by such means. | IVDs are medical devices & accessories used in-vitro for performing tests on samples like urine, blood, tissues taken from the body to help detect infections, diagnose a medical condition, and prevent diseases & so on. |
| Validity | The validity of Medical Device Registration is for 3 years. For the purpose of re-registration in the instance of the expiry of the Registration Certificate, the application for the renewal should be submitted 6 months before the expiry. | In India, the validity of test license is for one year unless the license is suspended or cancelled, whereas the Registration certificate IVDs is valid for three years. |
| Examples | Pacemakers, x-ray machines, tongue depressors, blood glucose meters, hip implants, MRI Machines, etc. | HIV tests, pregnancy tests, blood sugar monitoring systems for diabetes patients, hepatitis tests, etc. |
Principal Requirements for Medical Devices and IVDs
The principal requirements for both IVDs and Medical Devices are the QMS (Quality Management System), risk management, meeting the essential principles of safety & performance, design & development, manufacturing information & labelling. In general, meeting the requirements of certain standards like ISO 13485:2016 Medical Devices[1] – QMS – Requirements for regulatory purposes, ISO 14971:2019 Medical Devices; Application of Risk Management to medical devices & relevant guidance documents will provide a presumption of conformity with the vital principles of safety & performance.
Development and design principles apply for both Medical Devices and IVDs, starting with design planning from design inputs to outputs to verification & validation testing and capturing design changes. Manufacturing process & controls, descript of main systems or critical processes & description of critical assay ingredients, where relevant, are identical for both Medical Devices and IVDs.
There is no major difference in labelling requirements for Medical Devices and IVDs except for the particular symbols used to identify a medical device and/or IVD, recognised by similar but separate ISO standards.
Conclusion
The market of India has been a huge attraction to Medical Devices and IVDs manufacturers. However, there are many challenges ahead for the Regulatory Body in India, as it is at its starting phase & the regulations and rules must be amended & improved over time.
Read our Article:Who can apply for CDSCO License
