Whenever you think of marketing your product in a new market like EU, USA or global markets, if your company does not have a physical location, then you need an Authorized Representative who serves as a liaison between you and the National Health Authorities to comply to the Directives and Regulations. It is possible to nominate a distributor as your Authorized Representative; however, it is not advisable as most distributors are not equipped to execute the mandatory responsibilities of the Authorized Representative. To separate your commercial and regulatory interests, it is not a good idea to appoint a distributor as your Local Authorized Representative.
Our Role
As your Local and Authorized Representative, we act as a link between you and the health Authorities / notified bodies. As an independent organization, MakroCare can act as your regulatory guide and Authorized Representative to assist you to:
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Register your Medical Device or IVD with HAs or NBs before being placed in the market - Review & prepare Technical Documentation (if you need assistance)
- Maintain a copy of your Technical file available for inspection by the Competent Authorities and protect the confidentiality of your documentation
- Inform manufacturer about incidents & complaints in the shortest period.
- Notify Health Authorities of all major incidents pertaining to products when necessary
- Provide guidance in reporting Incident and Field Safety Corrective Action (FSCA), aligning you with your distributors
- Handle annual registration and listing
Register your Medical Device or IVD with HAs or NBs before being placed in the marketWhy MakroCare?
MakroCare developed this service over many years to specifically support the needs of small and medium-sized manufacturers.
- Experienced consultants, regulatory experts, and auditors who can understandany type of complicated device regulation and respond to any questions or concerns from HA/NB
- Our experienced consultants with deep experience in Global regulations, registering thousands of devices, enables a best, fast and efficient registration process.
- We have a global presence and our multiple offices across time zones can ensure a better reach for your products.
For More information? Get in touch with us.
Let's talk about how MakroCare can help you