A natural person, a limited business, or another entity like a partnership or charity may be the MAH. Marketing of the product is the responsibility of the MAH holder. The MAH is still legally liable even after designating a representative, such as a local agent or designated distributor.
The MAH serves as the main point of contact for the business producing or distributing the product and the regulatory bodies. In addition to answering regulatory questions and supplying any needed data or documentation, they oversee submitting applications for marketing authorization.
Generally, marketing, sales, and distribution rights for the product are owned by the MAH. They oversee the product’s marketing, price, distribution contracts, and other commercial factors.
The MAH, an organization takes over the product’s legal liability. This covers accountability for any injury or unfavourable outcome resulting from using the product.
OMC Medical possess extensive knowledge in managing regulatory obligations. We able to effectively manage the regulatory submission procedure and guarantee that the product satisfies all applicable criteria. OMC Medical will assist in reducing the risks related to product liability and regulatory compliance by making sure that all procedures are carried out in accordance with the most recent guidelines and standards.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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