Whenever you think of marketing your product in a different market like EU, UK, 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:
- 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)
- Handle annual registration and listing
Why 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 understand any 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 can handle local/regional
We’re here to help
Trust Our Decade of expereince acting as Authorized Representative for Medical Device companies in USA (FDA), UK (MHRA), and EU (NBs).
