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Operon strategist can assist Medical Devices companies for registration and licensing. In Case your company is large or small, domestic or foreign, we have the ability to the direction your regulative needs.

Operon strategist offers a range of Medical Device consulting, submission and auditing services including:

Preparation and submission of 510(k) pre-market notification to FDA approval.

Conducting quality system audits of medical device manufacturers.

Assistant medical device manufacturers to implement quality control/assurance, regulatory affairs, Handling compliant, document. Operon strategist provides the following services for FDA Registration

Manufacturing License in India

Our experienced professionals are familiar with all aspects of medical device regulatory compliance in India. Our services include obtaining Manufacturing License for medical devices in Form-28, medical device registration & approval for foreign manufacturers in Form 41 and import licenses in Form 10, Test license to manufacture drugs for purposes of examination, teat or analysis.

Manufacturing License in form 28 (For Indian Manufacturer)

  • Providing guidance to develop your manufacturing premises as per Schedule M- III.
  • Guidance for facility design.
  • Guidance for preparation and execution of equipment validation activity.
  • Guidance for preparation of complete documents.
  • Preparation and submission of an application to CDSCO, Zonal and state drug control authorities.
  • Providing complete support for inspection and audit.

Medical Device Registration Certificate in Form 41 (For Foreign Manufacturer)

  • Determine your devices are coming under the list of notified Medical Devices regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
  • Coordinate the device registration and approval process with Indian Medical Device Regulators (DCG(I)/CDSCO).
  • Guidance for Preparation of all necessary documents for the product registration application including Forms 40.
  • Assist to appoint an Indian Agent as your official representative.
  • Submission of Site Master File and Device Master File as needed.
  • Coordinate with the DCG(I)/CDSCO to address follow up questions and monitor progress.

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