The Implications for Manufacturers and Importers
This shift from mandatory registration to a licensing regime is not just a change in nomenclature. It brings with it a set of responsibilities and requirements that manufacturers and importers must be prepared for:
- An inspection will be mandated within 60 days from the date of application. This will be conducted by the Medical Devices Officers (MDQ) of the Central Licensing Authority (CLA).
- The purpose of this inspection is to ensure strict compliance with the Fifth Schedule of MDR 2017.
Official CDSCO Circular – Link
The Need for Expert Guidance
While the CDSCO aims for a seamless transition, the intricacies of the process can be daunting. Ensuring that all documents are correctly prepared, fees are processed accurately, and full compliance with the MDR 2017 is achieved, demands a deep understanding and expertise in the field.
How we can help you?
- Deep-rooted Expertise: With a rich history in the medical device regulatory domain, we possess the knowledge and skills to guide you meticulously through the licensing process.
- Holistic Services: Our services aren’t just limited to consultation. We provide comprehensive solutions, from documentation to regulatory guidance, tailored to your unique needs.
- Commitment to Timelines: In the medical device industry, time is of the essence. Our team is dedicated to ensuring that all processes are executed within the stipulated timeframes, preventing potential supply chain disruptions.
A Smooth Transition with Pharmadocx Consultants
Our primary goal is to ensure that your shift from mandatory registration to the licensing regime is devoid of hitches. We pledge to:
- Assist in the meticulous preparation and submission of all necessary documents.
- Provide expert guidance during the inspection process, ensuring you meet all the requirements of the Fifth Schedule of MDR 2017.
- Offer continuous support, keeping you updated on the latest regulatory shifts and requirements.
Q1: What are Class C & D medical devices?
Class C & D medical devices are typically those that are considered higher risk when compared to Class A & B devices. They require more stringent regulatory controls to ensure their safety and effectiveness.
Q2: How does the new licensing regime differ from the previous mandatory registration?
The new licensing regime mandates an inspection within 60 days of application submission, ensuring compliance with the Fifth Schedule of MDR 2017, whereas the previous system was based on registration without such stringent checks.
Q3: What happens if I don’t transition to the new licensing regime by 01.10.2023?
Failure to transition could lead to disruptions in the supply chain, and potential legal implications, and could affect the availability of the medical device to patients.
Q4: How can Pharmadocx Consultants assist in this transition?
We offer end-to-end services, from consultation, documentation preparation, and regulatory guidance, to ensuring compliance with MDR 2017. Our team will guide you through every step, ensuring a smooth transition.
Q5: Are there any additional fees associated with the new licensing regime?
The fees are stipulated by the MDR 2017 and can vary based on the device and its classification. We can provide a detailed breakdown based on your specific device.
Take Action Now!
Don’t let regulatory hurdles disrupt your business. Ensure a smooth transition and continued access to patients by partnering with the best in the industry. Contact Pharmadocx Consultants today and let us guide you through every step!
Read More –
- CDSCO Registration for Class C & Class D Rehabilitation Medical Devices
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