Legal support for manufacturers and distributors of medical devices
BRACE Law Firm, within the framework of the practice “Healthcare and Pharmaceutics”, provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. We provide legal assistance in the areas of business support, dispute resolution and litigation, public and corporate procurement, antitrust law, international trade law, and real estate issues.
One of the important areas of legal services of the practice “Healthcare and Pharmaceutics” of BRACE Law Firm is the legal support of manufacturers and distributors of medical devices.
Providing comprehensive legal assistance by ensuring that a company has a lawyer with specialized knowledge and practical experience can be very costly for organizations of manufacturers or distributors of medical devices.
Lawyers of the BRACE Law Firm have diverse specializations and are able to provide quality services in areas related to our specialization.
The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their governmental registration, production, manufacture, import into the Russian Federation, export from the Russian Federation, confirmation of compliance, control by competent authorities, storage, transportation, sale, installation, commissioning, application, operation, including maintenance, recycling or destruction.
It is possible to obtain basic information about medical devices on the Russian market and organizations (individual entrepreneurs) that manufacture medical devices from the state Register of medical devices.
It is important to note that the legal regulation of the activities of Russian manufacturers, as well as manufacturers of medical devices from the EAEU member states, has significant differences from the legal regulation of the economic activities of foreign manufacturers in the territory of the Russian Federation. Nevertheless, any manufacturers and distributors of medical devices are required to comply with the current legislation on the import/export to/from the territory of the Russian Federation and EAEU member states of medical devices, their registration, promotion, and advertising, interaction with different categories of customers, etc.
In addition to the need to comply with the above requirements directly related to the circulation of medical devices, there is a need to address a number of issues of manufacturers and distributors of medical devices related to taxation, building corporate relations, internal quality control, as well as representing interests in judicial instances and authorities vested with control powers.
Medical Devices Lawyers
The relationship between areas such as medical devices and law is becoming increasingly relevant.
Since manufacturing and medical devices is strictly regulated by the norms of Russian and international law, the ability to respond to possible legal risks on time is of particular importance. Indeed, often the adoption of decisions that are attractive to the business can subsequently lead to large losses in connection with the prosecution of the regulator or responsibility to customers or partners.
Doing business with a lawyer in a single person can sometimes cause problems in connection with his narrow specialization, while medical devices lawyers activity implies the presence of knowledge in various fields of law. The maintenance of the staff of lawyers can lead to a significant increase in the cost of legal support for the company.
To avoid such risks, it is recommended to consider the possibility of attracting a law firm with a staff of lawyers specializing in various areas of business support, and most importantly, the key area of activity of which is the provision of services to manufacturers and distributors of medicines, as well as other participants in the field of medical devices.
Lawyers in the medical devices field should know the legislation on the circulation of medicines, on conducting clinical trials, knowledge of customs and tax laws, and other aspects related to the activities of medical devices organization. Practical skills in resolving disputes, defending the interests of companies in regulatory bodies and court, and resolving conflicts between partners are important.
The main thing in the work of a lawyer in the field of medical devices is the ability to apply existing knowledge and skills, and the personal qualities of a lawyer who provides legal assistance and his willingness to understand any situation, openness to gaining new knowledge and a desire to improve their skills play an important role.
- Legal advice on medical devices
- Legal support in public procurement in healthcare
- Development and legal examination of contracts
- Development and legal examination of internal policies (anti-corruption, antitrust, and others)
- Legal advice on the protection of personal data in the field of healthcare
- Legal support for the promotion of medical devices
- Inspection Advice
- Advocacy against unfair competition
- Advice on the formation of lists of medicines
- Preparation of draft licensing agreements and agreements on the alienation of exclusive rights
- Registration of medical devices and amendments to registration documents of medical devices