Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
GST No. 27AFMPC2555H1ZH
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Medical Device Certification Consultant

We are Offering Medical Device Certification Consultant to our Client.

CDSCO Wholesale Registration Consultant

CDSCO Wholesale Registration Consultant
  • CDSCO Wholesale Registration Consultant
  • CDSCO Wholesale Registration Consultant
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Service Details:

Company LocationPan India
Type Of IndustryService
Company TypeServices, Industrial, Medical Devices
Mode Of ServiceOnline
Type of OwnershipAll
Type of ServiceNew company registration

The CDSCO Wholesale Registration Consultant  is responsible for regulating the registration & sale of notified medical devices in India.

We also help companies get the wholesale license to facilitate sale of their products in India.The Central drug standard control organization (CDSCO) is the national regulatory body or licensing authority for Indian pharmaceuticals and medical devices.

CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. The headquarter of the Central Drugs Standard Control Organization is located at New Delhi.


Medical Device Registration 
and CDSCO approval process In India.


Step1:
  • Is your product on the list below of Notified Medical Devices and IVDs which require device registration in India? Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, IV Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAG and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes.
Step2:
  • For medical device or IVD on list above, appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license (Forms 20B and 21B).
Step3:
  • For medical device or IVD on list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.
Step4:
  • For medical device or IVD on list above, file application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations.
Step5:
  • For medical device or IVD on list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.
Step6:
  • For medical device or IVD on list above, obtain Registration Certificate Form 41 from CDSCO. Certificate is valid for up to 3 years.
Step7:
  • Identify your distributor in India (holding forms 20B and 21B).
Step 8:
  • Apply for Import License using Forms 8 and 9 available from CDSCO. You must identify your chosen distributors on these forms.
Step 9:
  • btain Import License (Form 10) from CDSCO. License valid for 3 years.
  • You are now authorized to market your device in India.
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ISO 13485 Consultancy

ISO 13485 Consultancy
  • ISO 13485 Consultancy
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Service Details:

Document verification ModeOnline
Services offeredTraining
Type of CertificationNew Certification
Type of IndustryIT and Consulting
Type of Service ProviderIndividual Consultant

ISO 13485 Consultancy is a quality management system specifically developed for medical devices & related services. ISO 13485 can also be used by suppliers or external parties that provide the product, including quality management system relatedservices to such organizations. Operon Strategist helps clients develop, implement & maintain an efficientquality management system. We do an initial gap analysis of the existing system to determine the extent of development of the quality system. 

We Are Regulatory Project Consultant Service provider for Medical Device disposable implant manufacturers, Medical Disposable syringe manufacturers , Medical devices & surgical  instrument manufacturers,Orthopadic Implant Design Consultant , laboratory equipment manufacturers , Sterilization Equipment and Accessories Manufacturers , medical imaging systems manufacturers.
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510(K) Clearance & Premarket Approval Consultant Service

510(K) Clearance & Premarket Approval Consultant Service
  • 510(K) Clearance & Premarket Approval Consultant Service
  • 510(K) Clearance & Premarket Approval Consultant Service
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Service Details:

Type Of ServicesOnline
Type of Service ProviderConsulting Firm
Type of IndustryManufacturing
Type of Service ContractRetainer Based
Service LocationIndia

In US, the US FDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices, there is establishment & registration & device listing. Operon Strategist classifies the devices & gathers information about the company the products which is then uploaded through an online process. For class II devices, there is a process called the 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.

A 510(k) is a premarket submission made to FDA to show that the device to be advertised is at least as safe and effective, 510(k) implies it is considerably equivalent to a legally marketed device and isn’t liable to PMA. The legally marketed device(s) to which comparability is drawn is normally known as the “predicate.” Although devices recently cleared under 510(k) are regularly chosen as the predicate to which equivalence is guaranteed, any legitimately marketed device might be utilized as a predicate.


USFDA Medical Devices 510(k) File Submission: 

  • Operon Strategist helps client in classification of the device after consultation with the client. Thereafter, the 510(k) process is explained & the scope of work is explained. After conferring with the client, we establish the predicate device & testing requirements as per US FDA
  • consensus standards. We help in compilation of the 510(k) file, review of test reports, and submission of the file to US FDA & correspondence with US FDA.
  • We also help in handling the queries raised by the US FDA reviewer. We support the client until they receive the 510(k) clearance letter.
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CE Marking Consultant

CE Marking Consultant
  • CE Marking Consultant
  • CE Marking Consultant
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Service Details:

Type of CertificationNew Certification
Type of IndustryIT and Consulting
Type of Service ProviderIndividual Consultant
Mode Of ReportHard Copy

The CE Mark Consultant is a conformity mark which all medical devices must have before they can be marketed.It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact with the body & ; the duration of contact.


Experienced industry professionals  are handled CE  Requirement services by  who have necessary knowledge as well as in depth knowledge of meeting the demands of CE Mark Consultant.


Our team supports clients in meeting “European submission” standards that declares the product offered is in compliance with Essential Requirements of relevant European safety, health and Environmental protecting regulation.

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GMDN Number Assessments Consultant Service

GMDN Number Assessments Consultant Service
  • GMDN Number Assessments Consultant Service
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Service Details:

LocationIndia
Type Of ServiceNew company registration
Services IncludeRegistration
Service ModeOnline

GMDN Number Assessments Consultant Service offered is handled by experienced industry professionals who have with them rich process experience so as to assure delivery of quality and solutions. The Global Medical Device Nomenclature solutions offered comprises an international system which is used for identifying as well as classification of medical devices as well as support distinguishing one type of medical device from another.

Some of its features include:
  • Allow medical devices with similar features to be identified
  • Used for assisting consistent assessment of medical devices before getting approved for supply
  • For exchanging post-market vigilance information between regulatory bodies
  • Services support clients in updating database in alignment with technological advancements
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US FDA 21 CFR Part 820 Quality System Regulation Consultant Service

US FDA 21 CFR Part 820 Quality System Regulation Consultant Service
  • US FDA 21 CFR Part 820 Quality System Regulation Consultant Service
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Service Details:

Industry to CaterHealthcare
Service Duration2-7 Days
Service ModeOnline
LocationIndia

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). 


US Govt. give flexibility of QS regulation. this regulation does not prescribe in detail about how a manufacturer must produce a specific device Rather, the regulation provides the framework that all manufacturer must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

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Reach Us
Anil Chaudhari (Proprietor)
Operon Strategist
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway, Morwadi, Pimpri Colony
Pimpri Chinchwad - 411018, Maharashtra, India


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