Slick Slider

Local Authorized Representative

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:

  • Bullet Register your Medical Device or IVD with HAs or NBs before being placed in the market
  • Bullet Review & prepare Technical Documentation (if you need assistance)
  • Bullet Maintain a copy of your Technical file available for inspection by the Competent Authorities and protect the confidentiality of your documentation
  • Bullet Inform manufacturer about incidents & complaints in the shortest period.
  • Bullet Notify Health Authorities of all major incidents pertaining to products when necessary
  • Bullet Provide guidance in reporting Incident and Field Safety Corrective Action (FSCA), aligning you with your distributors
  • Bullet 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.

  • Bullet Experienced consultants, regulatory experts, and auditors who can understandany type of complicated device regulation and respond to any questions or concerns from HA/NB
  • Bullet Our experienced consultants with deep experience in Global regulations, registering thousands of devices, enables a best, fast and efficient registration process.
  • Bullet 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.

Close
The First Step

Let's talk about how MakroCare can help you