Anuradha Shaha – Page 3 – Operon Strategist

Understanding the Unique Device Identification (UDI) System for Medical Devices

UDI – Unique Device Identification Medical device regulations were implemented in the European Union in 2021 to make the medical device safer, more effective, and easy to trace in case something goes wrong. With the technological advancement, it was the main concern for the EU-MDR to trace those devices that either shows failure or adverse […]

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Post-Market Surveillance for Medical Devices

Around the world, medical devices play a vital role in the diagnosis, treatment, cure, prevention, or mitigation of disease, disorder, or conditions. Medical devices can be instruments, apparatus, machines, implants, or other similar objects that professionals can use. Around the world, regulatory bodies or authorities regulate medical devices in terms of quality, safety, and efficacy.

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State License Authority To Accept Hard Copy Of Application

State License Authority (SLA) Now the DCs means drug controllers need to accept hard copy of the application to issues registration certificates to trade medical devices and IVDs, which has been announced by the Union health ministry as an alternative to drugs sale license for these devices. CDSCO has received various representation regarding the

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A Guide to SaMD (Software as a Medical Device)

Overview of SaMD Gone are the days when medical devices were confined to only apparatus, implants, or objects. Now medical devices cover software as well. The software helps to diagnose or cure diseases, disorders, or conditions and helps to decide the course of treatment. Medical Device Software development makes life easier but comes with threats

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Know More on Ophthalmic Devices, Their Manufacturing, and Compliance

What are Ophthalmic Devices? In simple language the medical devices used in optometry and ophthalmology are termed as Ophthalmic devices. The examples of Opthalmic devices are contact lenses, intraocular lenses, glaucoma stents. Ophthalmology is a branch which deals with the structure, function and various eye diseases. Ophthalmic devices are medical equipment designed for the diagnosis

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CDSCO: Changing Regulatory Scenario and Its Impact

The changing Regulatory scenario always having an impact on medical device manufacturers. Central Drug Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health & Family Welfare. CDSCO regulates the manufacturing of medical devices of all classes. So that devices manufactured are safe to use, have good quality, have high

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Everything You Should know About Wearable Medical Devices

Wearable Medical Devices: An Overview In recent years, wearable technology in healthcare has taken the world by storm, transforming various aspects of our lives. One particular area where wearables have made significant strides is in the field of healthcare. Wearable medical devices have emerged as powerful tools that can monitor and improve our health in

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How has EU-MDR affected CE Marking for Medical Device Manufacturers?

An Overview: All those devices sold in the European Union market must bear CE marking. EU-2017/745 EU medical device regulation was approved on 5th April 2017 by the European Union and EU authorized representative to cover the weakness and improve the safety, performance, and efficiency of medical devices marketed in the European Union. To ensure

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Registration Certificate to Sell or Distribute A Medical Device

Recently The department of health and family welfare released a notification in relation to obtaining Registration certificate to sell, exhibit, or distribute medical devices including IVDs. The State Licensing Authority shall appoint a Licensing Authorities for the purpose of issuing registration certificate. The highlights of Notification for “ Registration certificate to Sell or Distribute A

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CDSCO Regulatory Compliance : It’s Not as Difficult as You Think

The medical device industry plays a crucial role in the country’s healthcare sector. Country’s medical device market influenced by multinationals. India is among top 20 countries in world for the medical devices market. Our government is putting efforts to strengthen the sector; innovation and new technology, proficient people in the area becoming the pillar of

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