The term medical device refers to any instrument, device, implement, machine, implant, reagent for in vitro use, software, material or other similar article or related to medical practice.
Medical devices are essential so that the prevention, diagnosis, treatment and rehabilitation of diseases and ailments are safe and effective. The achievement of development objectives related to health, including the Sustainable Development Goals, depends on the manufacture, regulation, planning, evaluation, acquisition, management and use of medical devices of good quality, safe and compatible with the environments in which they are developed. They are used as stated in resolution WHA60.29 of the World Health Assembly, the mission of the staff dedicated to medical devices in the Department of Essential Drugs and Health Products is to ensure better access, quality and use of safe and adequate medical devices in accordance with the provisions of the reform of primary health care.
When choosing a medical OEM partner it is important that it meets certain characteristics that ensure that this relationship will be fruitful for both.
The use of state-of-the-art technology is a very important aspect since it guarantees a product of the highest quality and a relevant adaptation to the needs of each user.
In current medicine it is essential to use state-of-the-art equipment that facilitates the daily activity of patients who have some type of disability or illness, obviously without neglecting the maximum performance of the equipment with a minimum of energy consumption.
Certificate of Free Sale
The OEM must have a certificate of free sale issued by the competent regulatory authority, which certifies that the product referred to in the certificate is authorized for sale, use and distribution in the country or region of origin. This certificate may include one or more products and must not be older than two years after its issuance
For a good partnership to develop, it is essential that both parties work together to achieve mutual goals.
The Partnership must be established with institutions that maintain a vision and values similar to yours, that share the same goals and with whom a good affinity is established. Before starting an Partnership project, you should try to get to know this possible new partner, not only in the business sector, but also in the personnel.
Every project will require time and sacrifice, therefore it is essential that the partners show a similar level of commitment.
Most problems among people are related to communication problems. In every project of association always arise altercations; the key is that through the dialogue can be obtained a consensus decision that benefits both.
A good medical OEM partner must have human resources trained and experienced in the field of medicine, in order that they provide their clinical and technical knowledge for the development of equipment that adapts to the different situations that arise in the medical practice of which they are participants.
Before establishing an association with a medical OEM, you must ensure the quality and trajectory of the company. Companies with more than 30 years of experience ensure stability and reliability.
Registration with the FDA
Owners or operators of commercial sites involved in the production and distribution of medical devices must register annually with the FDA. This process is known as an establishment record. All establishments that are required to register with the FDA must also present the list of medical devices they produce, as well as the tasks for which these devices are designed. The owner / operator must submit the FDA pre-commercialization number if they want their medical device to obtain approval for marketing in the US.