Senior Regulatory Affairs Executive
4 Years of Experience Medical device regulatory professional specializing in EU MDR 2017/745
Respiratory medical devices are specialized tools for breathing and lung challenges. They offer extra oxygen, maintain airways, and assist with medication delivery. Designed for various conditions like asthma and COPD, these devices optimize breathing and enhance lung function. They are tailored to address diverse respiratory conditions, spanning from routine ailments like asthma to intricate disorders like COPD. One of the most common respiratory devices you’ve likely encountered is the pulse oximeter. But there are more that have been included in the blog below.
Know more about CDSCO Registration Process for Medical Devices
Information About an Update on Compulsory Registration for Class C and Class D Medical Devices
Starting from October 1, 2023, Class C and Class D medical devices, which were previously required to be registered, will now need to follow a licensing regime as per the recent circular issued by the Central Drugs Standard Control Organization (CDSCO) on April 12, 2023. This transition aligns with GSR 102(E) dated February 11, 2020.
Manufacturers and importers seeking a manufacturing or import license for these devices should apply online via the CDSCO portal. The application process must include necessary documents and fees, following the guidelines of the Medical Devices Rules (MDR) 2017.
Notably, within 60 days of the application, a Medical Devices Officer (MDO) from the Central Licensing Authority (CLA) will conduct an inspection to facilitate the granting of the manufacturing license for Class C and Class D medical devices, as stipulated by the Medical Devices Rules (MDR) 2017.
However, success in this highly regulated industry depends on one critical foundation a well-prepared Detailed Project Report (DPR).
Some Class C and Class D Respiratory Medical Devices Are Listed Below
Sr. No. | Device Name | Risk Class |
1. | Artificial airway washing/disinfection jar | C |
2. | Breathing circuit washer/disinfector | C |
3. | Hyperbaric chamber | C |
4. | Pulse oximeter | C |
5. | Implantable sleep apnoea treatment system | D |
For a more comprehensive list, please refer The Classification of Medical Devices Pertaining to Respiratory
Documents Required for CDSCO Manufacturing License of Class C and Class D Respiratory Medical Devices -
Obtaining a manufacturing license from CDSCO involves comprehensive compliance, encompassing facility standards, systematic protocols, and detailed documentation. This approach ensures the production of medical devices that meet stringent quality and safety criteria.
Documents Required for CDSCO Import License of Class C and Class D Respiratory Medical Devices
For CDSCO import license, obtaining an Approval Certificate and a Free Sale Certificate (FSC) from recognized regulatory bodies in countries like the USA, EU, Japan, Australia, and Canada is essential. These certificates confirm the adherence of medical devices to global quality standards and their approval for unrestricted sale, playing a pivotal role in assuring safety and quality during the importation process.
Operon Strategist is here to help with all your needs related to respiratory medical device rules and regulations. We are experts in making sure your devices meet the right standards required by the authorities. Our job is to make the complicated process of getting approvals and certifications simple for you. Our team will guide you from the start to the finish, making sure all the necessary documents are ready and helping with submissions, and following the rules even after your device is on the market. If you’re looking for help in this area, get in touch with us today!
Know more about Respiratory Medical Devices and Regulatory Compliance
FAQ
What are respiratory devices?
Respiratory assist devices include devices intended to help patients in need of support for breathing, removal of carbon dioxide, and therapy to reduce disuse atrophy of abdominal wall muscles.
What are the two types of respiratory equipment?
There are two main types of respiratory protection—air-purifying respirators (APRs) and atmosphere-supplying respirators (ASRs). Each respirator type provides a different level of protection based on its design.
What is the importance of respiratory devices?
A respirator is a requirement in preventing diseases that result from inhaling contaminated air. These devices are necessary for protecting patients from dangerous environments with low oxygen levels and hazardous air particles.
Senior Regulatory Affairs Executive | 4 Years of Experience
Medical device regulatory professional specializing in EU MDR 2017/745 technical documentation, CE marking, risk management, clinical and biological evaluation, and post-market surveillance. His expertise includes SFDA MDMA submissions, CDSCO licensing, ISO 13485, MDSAP, US FDA regulatory requirements, and BIS certification.
