Anuradha Shaha – Page 4 – Operon Strategist

CDSCO Class A Non-sterile And Non Measuring

CDSCO Notification For Class A Non-Sterile And Non Measuring Medical Device

CDSCO Notification For Class A Non-Sterile And Non Measuring Medical Device CDSCO has issued notification to smoothen the licensing process for Class A medical devices. The Class A Medical devices are those having low to moderate risk like surgical dressings. CDSCO issued a notification on 20 September 2022, which explains that the medical devices of […]

CDSCO Notification For Class A Non-Sterile And Non Measuring Medical Device Read More »

Regulatory & Manufacturing Aspects of Wound Care Dressing Medical Devices

Wound care dressing medical device manufacturing: Wound care dressing is categorized on the basis of the risk associated with their use. They are categorized as medical devices but they are not clearly defined. So, when setting up manufacturing units or importing them for the business, one may face regulatory obstacles. Our highly experienced team members can

Regulatory & Manufacturing Aspects of Wound Care Dressing Medical Devices Read More »

Is India lacking in Medical Device Manufacturing?

Recent years India is showing growth in healthcare industry. As per the data from various sources Indian medical device industry is Fourth largest in Asia and among top 20 globally.Despite of all these and efforts taken by government of India, Medical device manufacturers are facing challenges in this sector. Few statistics shows that despite of

Is India lacking in Medical Device Manufacturing? Read More »

Clarity On Classification Of Medical Devices

CDSCO issued clarity on classification of medical devices. The detailed lists of medical devices classification are mentioned below. If you require more understanding on how the classification of medical devices are done by CDSCO. Refer to the article that explains the method and example of classification. Clarity on Classification of Medical Devices : Dental To

Clarity On Classification Of Medical Devices Read More »

How to Choose a Medical Device Regulatory Consultants?

Medical Device Regulatory Consultants Medical device consultancies or regulatory consultants are highly experienced professionals from the healthcare industry. With rapid positive growth in medical science, the medical device industry is coming up with more and more advanced devices. But launching a new product on the market is not easy. The devices should comply with all

How to Choose a Medical Device Regulatory Consultants? Read More »

FDA Guidance on UDI Compliance Requirement for Low-Risk Devices.

On July 22, 2022 FDA has posted a guidance on UDI I.e Unique Device Identification system. This particular guidance explains the FDA’s compliance policy regarding Global Unique Identification Database submission requirement (GUDID) for Class I devices which are considered consumer health products. FDA defines consumer health products as “510(k)-exempt class I devices that are sold

FDA Guidance on UDI Compliance Requirement for Low-Risk Devices. Read More »

eIFU in Medical Devices & Labelling for Medical Devices as per EUMDR

Instruction for Use (IFU) The manufacturer provides information to the intended user on how to operate the item securely for its intended purpose. In some international jurisdictions, the IFU is referred to as directions for use. Electronic IFU (eIFU in medical devices) eIFU in medical devices means instructions displayed in electronic form: by the device (“help”

eIFU in Medical Devices & Labelling for Medical Devices as per EUMDR Read More »

Selection of a Notified Body and Their Process for your new device authority

Notified Bodies an overview: You must have your device CE marked before you may market it in the European Union. Additionally, medical device manufacturers must submit to a conformity assessment conducted by a Notified Body for all but for the lowest risk products (Class I) (NB). A Notified Body is a third-party organization that has

Selection of a Notified Body and Their Process for your new device authority Read More »

How to Use ISO 13485 Standard For CE Marking Approval of Medical Devices?

The CE marking grants access to European markets for medical devices, whether produced within or outside the EU. Manufacturers must obtain and display the CE mark before placing products in the European Economic Area (EEA). If imported, this responsibility shifts to the importer. “CE” represents European Conformity,” translated from the French term “Conformité Européen”. ISO

How to Use ISO 13485 Standard For CE Marking Approval of Medical Devices? Read More »

What is CDSCO SUGAM?

Medical Device SUGAM Portal –An Overview CDSCO SUGAM is an online portal introduced by CDSCO I.e Central Standard Control Organization in early year of 2016. This portal is useful for various applications for various services. CDSCO SUGAM is an online web portal through which the applicants can apply for NOCs, licenses, CDSCO registration certificates, permissions

What is CDSCO SUGAM? Read More »