Canadian business laws and regulations Essay

The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs and medical devices that are offered for sale in Canada are safe, effective and are of high quality. The TPD also administers fee regulations for drugs and medical devices under the authority of the Financial Administration Act. All Federal Acts and associated Regulations are available on the Justice Web site. The CMDR or The Canada medical device regulation laws can be downloaded from the following website below. http://laws. justice. gc. ca/en/notice/index. html? redirect=%2Fen%2Ff-27%2Fsor-98-282%2Ftext. html Its important that each law and clause is well read and analyzed before submission of the evidence/test report for the device approval. C: MY ROLE AS AN ENTREPRENEUR: I would be involved in strategic planning and management of the company. My work would preferably be product development and testing working in synchronization with the design and testing team. I would pick my own team and assign duties and responsibilities to each member of the team. PART 3: A: MARKETING: MARKET ANALYSIS: The market for spinal implants in South-east Asia is still nascent. The need would be to convince the people of long term benefits of a spinal implant in comparison to alternative medicines. This would not only alleviate back pain but also would improve the quality of life. Inspite of a nascent market, there is a great potential for growth in the next ten years. Our main aim would be to highlight the benefits of Prime disc especially the less non-invasive surgical procedures and initial payment of surgery by Spinal dynamics for the first 10 patients. We would gradually tie-up with Apollo Group of hospitals, Canada. Apollo Group is boasts of over 8000 beds in more than 41 hospitals, a string of nursing and hospital management colleges and dual lifelines of pharmacies and diagnostic clinics providing a safety net across Canada. It also has team of excellent, high profile neurosurgeons and orthopedic specialists. Spinal dynamics would sponsor seminars, backed by various medical practitioners to instruct future patients and improve its brand value. Our company will aim to capture at least 10% of total spinal implants market by fourth year of operation. The company’s marketing activity will start immediately after start of operations, and will concentrate on the requirements of prospective patients, with the aim of obtaining a sizable contract from a health institution. Public announcements will take place one year from the start of operations and will be heavily publicized in trade journals, brochures and shows. The devices will be exhibited at the annual orthopedic research society’s (ORS) annual meeting. Spinal dynamics will have its own stall, with information about its device etc. By this time, the company would have worked an agreement with another concern for marketing and distribution of its products. Regional offices will be set up at the four major metros of Canada, as this would improve the products sale ability and distribution. Once the product is well accepted a number of sales officers would be employed with a chance of an International center preferably in the U. S. A very detailed and lucid website would be designed with product information in order to furnish the requisite information to the doctors and the patients. CUSTOMER PROFILE Age 20-85 Sex M/F Disease/ symptoms Degenerative disc disease, black disc, chronic low back pain Income $20,000 (USD) Geographical Location Canada, south east Asia.