Manufacturing Requirements for Blood Pressure Monitor Devices and Regulatory Compliance

Blood Pressure Monitors an Overview: 

One can accurately check their blood pressure using a blood pressure (BP) monitoring device. It consists of a pump, a sensor that measures air pressure, and an elastic cuff. When the cuff is put on the user’s left arm, the artery beneath it is controlled to contract and release. It’s used to assess how much blood the heart pumps. The market has seen the introduction of many low-cost, portable blood pressure monitors.  

They are easy to use and have a large reading display. These electronic devices may also record a significant number of earlier readings, which help users in keeping track of their average blood pressure. The rise in chronic diseases is the key factor driving the market growth of BP monitor medical devices. Therefore, the government has made it mandatory for BP Monitors to register with CDSCO for medical devices, and it has stronger regulations for production facilities. Only a licensed premises is allowed to manufacture medical device. As a turnkey project consultant we provide detail project report to medical device manufacturers so that they understand the whole procedure for license premises. 

Requirements to Start Blood Pressure Monitor Medical Device Manufacturing Company: 

• Factory premises 
• Technical staff 
• Machinery  
• Lab equipment 
• Electricity supply 
• Licenses required like Registration license, manufacturing & testing license etc. 

How do we Help Blood Pressure Monitor Device Manufacturers / Importers to Set-up the Manufacturing Units? 

The manufacturing of medical devices must take place at permitted facilities and must be divided into the separate operations. To start medical device manufacturing company manufacturing plant layout designing is the primary step. These designs must be complied with the respective regulatory body, means if you are planning to setup the unit in India you need compliance with CDSCO regulations, and to obtain regulatory compliance you can take assistance from our regulatory experts.  

We assist and provide guidance to manufacturers about plant layout design, validation and verification of devices, and clean room specifications as per the regulations required by the region.  

A blood pressure monitor is notified medical device which is used to measure diastolic and systolic blood pressure so CDSCO registration is mandatory. This device is classified as Class B device as low to medium risk associated with this device. CDSCO classifies medical devices as Class A-low risk, Class B-low to medium risk, Class C- Medium to high risk and Class D-High risk devices. As an experienced CDSCO regulatory consultant we classify medical devices and provide guidance for the regulatory compliance to the medical device manufacturer. 

Take look at FDA Regulations on Blood Pressure Monitor Devices: 

All medical devices, including blood pressure monitors, must be safe and effective, according to the FDA. To achieve this, the FDA reviews the design and manufacturing of these devices before allowing them to be sold in the USA. Additionally, the FDA mandates that instructions for usage and a list of potential risk be printed on the label of blood pressure monitors. The FDA also suggests that manufacturers give patients a user manual that explains how to operate the device correctly. The FDA will only approve a blood pressure monitor device if it fulfills its safety and effectiveness requirements. So, if you want to sell blood pressure monitor or manufacture blood pressure monitor device you need to first classify your device and according to the classification FDA 510(k), PMA or de novo pathway will be applicable. As an FDA 510(k) clearance consultant we assist blood pressure monitor device manufacturers in creation of technical file, implementation of QMS as per 21CFRpart820, and design development of devices.