Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
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Medical devices Authorised Representative Service

Pioneers in the industry, we offer authorised representative service from India.

Authorised Representative Service

Authorised Representative Service
  • Authorised Representative Service
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Approx. Price: Rs 1 / UnitGet Latest Price

Service Details:

Type of CertificationNew Certification
Type of IndustryChemical
Type of Service ProviderConsulting Firm

Your Authorised Representative Service in the USA as a liaison between you and the national Competent Authorities (Ministries of Health). It is possible to appoint a distributor as your Authorised Representative in the USA, but it is not recommended because most distributors are not prepared to fulfil the mandatory responsibilities of the EC REP. Instead, select an independent representative that will focus on regulatory affairs, rather than sales and marketing. Read more about the benefits of hiring an independent firm to act as your EC REP in the USA.

Additionally, your appointed representative will:
  • Assist with certain device registrations, as required
  • Be identified on your product labelling throughout the USA
  • Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
  • Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors
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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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