Invasive blood pressure monitors need to comply with the regulations and standards of each country or region during the product registration process, and the following are the general regulations and standards:
ISO 81060 series
ISO 81060-1: General requirements and test methods for non-invasive and invasive blood pressure measuring instruments.
ISO 81060-2: Special requirements and test methods for invasive blood pressure monitoring instruments.
ISO 81060-3: Additional Requirements for Non-Invasive and Invasive Blood Pressure Monitoring Instruments.
IEC 60601 series
IEC 60601-2-30: Special requirements for medical electrical equipment for invasive blood pressure monitors.
IEC 60601-1: General requirements for medical electrical equipment.
FDA 510(k) pathway
A 510(k) application is required to prove the similarity and equivalence of new products and ensure product safety and efficacy.
GMP requirements for medical devices
Comply with the requirements of the US FDA for medical device production quality management to ensure that the products meet good manufacturing practices.
Medical Device Directive (MDD).
Comply with the basic requirements of the European Union for medical devices and obtain CE certification to ensure that the products meet the EU market access standards.
ISO 13485 Quality Management System
Manufacturers are required to follow a strict quality management system to ensure product quality and compliance.
Measures for the Administration of Medical Device Registration
Including the management regulations of the whole process of medical device registration, production, sales and so on.
Guidelines for Technical Review of Medical Device Registration and Declaration
It stipulates the technical requirements and review procedures for the registration and declaration of medical devices.
These regulations and standards provide the basic requirements for invasive blood pressure monitoring devices to be met during the product registration process. During the registration process, it is necessary to follow the corresponding standards and regulations according to the characteristics of the product and the specific requirements of the sales market to ensure the compliance and safety of the product. At the same time, with the development of medical technology, regulations and standards may also be updated and modified, and it is necessary to pay attention to the latest requirements in a timely manner.