CDSCO Registration And Wholesale License Certificates. CDSCO Guidelines & Medical Device Registration Step 1: Check if the product you wish to register is on the Notified Medical Devices and IVDs list.
Step 2: Contact an authorized agent, having a license for manufacture, distribution and/or wholesale license for sale can make an application for grant of import license for the medical device to the Central Licensing Authority We at Operon Strategist walk with you throughout the process to help you get the required license smoothly. Contact us today Step 3: Next step is to submit the application and specified fees for the process.
CDSCO Manufacturing License in India. Phase I – Applicant RegistrationPhase II – Test License applicationPhase III – Manufacturing license application Pre-requisite: Generic Name / Brand NameIntended UseMaterial of constructionMode of application Introduction: The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the Food and Drug Administration of the United States (FDA) it is a plan announced by the way government to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organization (CDSCO).
CDSCO manufacturing license of medical devices is covered under CLAA scheme and signed for granting by State Licensing Authority may be considered for approval by CLAA with the condition that licensee shall fulfill requirements of Medical Devices Rules. CDSCO Manufacturing license. CDSCO Manufacturing license. Turnkey Project Consultants. Turnkey Project Consultants. Turnkey Project Consultants. Operon Strategist has a team of trained professionals that work according to set standards and constantly upgrading their work techniques that assure meeting customer requirements timely and as per defined quality standards.
To serve the diverse requirements of the clients we are the best Turnkey Project Consultant, wherein we assist our customers by offering comprehensive solutions to create Manufacturing Plant Layout Design that suits the client’s requests and requirements in their turnkey project while adhering to industry environmental standards, partner product installation standards and customer quality standards. We follow a well-defined work methodology for organized working which leads to zero-errors and higher-efficiency, that assures meeting customer requirements timely and as per defined QMS Certification Standards.
We build a long-term relationship with customers based on trust, quality work and on-time service. US FDA 21 CFR 820.30 Design Control Requirements. ISO: ISO 13485 is the worldwide acknowledged standard by the International Standards Organization for medical device Quality Management System.
The standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high-quality medical devices that reach up to customers and regulatory requirements. ISO 13485 can be used by any company involved in the transfer of medical devices, providing, support phases. Furthermore, it can also be used by external or internal auditors to support the inclusive audit process. 21 CFR Part 820: FDA 21 CFR Part 820: covers up the process used in & the facilities and controls used for the design, manufacture, packaging, labelling, storage, installation, & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820 & only compliance with the requirements is assessed. Medical Device Certification. We provide the following consultation certification for manufacturers US FDA 21 CFR Part 820 Quality System Regulations: This process covers the facilities and control used for the design, manufacturing, packaging, labelling, storage, installations for medical devices. 21 CFR Part 210 & 211 Quality Assurance:This Process deals with manufacturing, packaging, or holding if drugs and pharmaceuticals.
ISO 13485 Certification: It is the world acknowledged standard by the International Standards Organization for medical device quality management system. It can be used by any company involved in the transfer of medical devices. This specifies the requirements for a QMS certification. QMS certification For Medical Devices. QMS certification For Medical Devices. ISO 15378 Certification Operon Strategist. ISO 15378 Certification Operon Strategist. US FDA 21 CFR 820.30 Design Control Requirements. US FDA 21 CFR 820.30 Design Control Requirements. US FDA 21 CFR 820.30 Design Control Requirements. Primary Packaging Regulatory Consulting. ISO 15378 Certification is a quality assurance for primary packaging materials for medical products specific prerequisites for the utilization of ISO 9001:2008, with reference to GMP.
In 2006, the procedure-oriented ISO 15378 standard was delivered. In view of the globally acknowledged ISO 9001 quality standard, it contains all the GMP essentials appropriate to primary packaging material, for example, batch tracing, risk management, validation, and controlled environment. FDA 21 CFR Part 820 Quality system Regulation. CDSCO Import License for Medical Devices. ISO 13485 Certification. ISO: ISO 13485 is the worldwide acknowledged standard by the International Standards Organization for medical device Quality Management System.
The standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high-quality medical devices that reach up to customers and regulatory requirements. ISO 13485 can be used by any company involved in the transfer of medical devices, providing, support phases. Furthermore, it can also be used by external or internal auditors to support the inclusive audit process. 21 CFR Part 820: FDA 21 CFR Part 820: covers up the process used in & the facilities and controls used for the design, manufacture, packaging, labelling, storage, installation, & servicing of medical devices.
Manufacturers are inspected by the US FDA as per Part 820 & only compliance with the requirements is assessed. Medical Device Design and Development. Medical Device Design and Development. CE Marking Certification Consultant for Medical Device. CE Marking Certification Consultant for Medical Device. CE Marking Certification Consultant for Medical Device. FDA Regulations for Hand Sanitizer Manufacturing. Due to the ongoing public health emergency, alcohol-based hand sanitizers will be in high demand.
The FDA regulates and conducts hand sanitizers as an over-the-counter (OTC) drug.Hand Sanitizer Manufacturers presently involved with packaging, production of ethyl alcohol and isopropyl alcohol, raw equipment, packaging, and Current Good Manufacturing Practices (cGMP) requirements have an urgent opportunity to go into this market. Leveraging our broad expertise in FDA cGMP regulations, Operon Strategist can help guide your Hand Sanitizer Manufacturing Company through the FDA Regulation and drug registration process.
Certification Courses - Training Academy. Who should attend?
: Final Year Engineering Students / Graduates / Medical Devices Professionals / Quality & Regulatory Affairs Enthusiasts who are look to build a career in the Medical Devices Quality & Regulatory Affairs. Level 2 Course will consist of 10 sessions in total followed by assignments with two case studies. The course consists of 12 modules, of which 9 are mandatory and the students get to choose one module of their interest from the 3 elective modules. The Elective modules are I, J & K as listed below. Authorized Representative For Medical Devices. Article 14 (2) of the medical device directive states; Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorized representative in the European Union.Therefore for manufacturers of medical devices who can be accurately described by the above, it is a legal requirement to appoint a European Authorized Representative for medical devices.
A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative. Your European Authorized Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies. Why do you need a European Authorized Representative for medical devices? 24 hour-AR.
Emerging Medical Device Manufacturers. Emerging Medical Device Manufacturers, this is the perfect storm; one that means they have to invest in infrastructure. Taking a close look at emerging markets makes one realize that the need for medical device design and technology was always there, but it has now become more imperative and essential than ever. An evident rise in the standard of living also increases the need for safe, reliable and highest quality medical devices. It is also needless to mention that the explosive growth of health insurance compliments the growth of Emerging Medical Device Manufacturers. As a result, medical device manufacturers are undertaking new product development projects at breakneck speed, especially in the emerging markets such as China and India. Person Responsible for Regulatory Compliance. The Person Responsible for Regulatory Compliance does not replace the European Authorized Representative (EC Rep). However, the two roles are symbiotic.
As you know, your EC Rep must be located in Europe and meet requisite qualifications that are well defined in the MDD/IVDD and MDR/IVDR. The EC Rep’s name and address must appear on labeling. However, the EC Rep does not have nearly as many responsibilities as those assigned to the Person Responsible for Regulatory Compliance. Who can be a PRRC? Medical Device CE Mark. EU MDR – Medical Device Regulation Difference in MDD and MDR The MDR i.e.