What Is The Voluntary Medical Device Registration?
Government Notification:- As per the Gazette Notifications GSR 102 (dated 11 Feb 2020), besides the certain medical devices, rest all are under the category of nonregulated medical devices. As the name suggests, these devices are not yet regulated by CDSCO, as it is according to the Medical Device Rules 2017.
The time period for voluntary registration:- For non-regulated medical devices, CDSCO has introduced a scheme of voluntary/compulsory registration. As per this scheme, registration is mandatory on a voluntary basis for a period of eighteen months from the date of this notification (ie till September 2021) and thereafter. The manufacturer or importer shall mention the registration number so obtained on the label of the medical device.
Relaxation period limited by the government: - After a period of thirty months (ie September 2022) for low risk - category A and low medium risk - category B and forty-two months (ie September 2023) such exemption will expire. Medium-High Risk – Category C and High Risk – Category D devices, respectively from the date of this notification i.e. such non-regulated medical devices shall be regulated as per MDR 2017 after the above time period.
After that, it will be mandatory to fulfill all the requirements mentioned in MDR 2017, that is, for manufacturing or selling of medical devices or in-vitro medical devices or for importing for distribution.
What Are The Documents Required For Voluntary Registration?
ISO 13485 Certificate
Free Sales Certificate (in case of import)
What is the government fee for voluntary registration?
There is currently no government fee for voluntary registration of a non-regulated medical device.
How long does it take for voluntary registration?
If the customer has documents like ISO 13485 and Free Sales Certificate (in case of import) available, we help to do voluntary registration within 24 hours.
Importance of voluntary registration during import
Voluntary registration is required for the import of any type of non-regulated medical device. An importer presents a registration number or a file number generated after voluntary registration to the Customs Officer.
What do I have to do after the voluntary registration period is over?
Contact us for voluntary registration of your medical device, whether you are an importer or a manufacturer. We assure to give you the registration number at the earliest, no matter how complicated your case may be. We provide better services at an economical price.
ELT Corporate and Medical Device Registration:
ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs & Cosmetics, Medical Devices, Food Safety, and Environment Safety to New Technology Patents. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, and Company Secretaries. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large corporates.
ELT Corporate is one of the best Medical Device Ragistration Consultant in India and always try to provide the best experience to our clients.
How We Can Help You With Medical Device Registration?
- We help our clients to communicate with government portals and ministries to get licenses.
In short, we assure our clients about any regulatory requirement for the Medical Device in India.
We help our clients to develop all the documents whether it is Device Master File, quality manual, or management responsibility as the case may be.
We help our clients to maintain various records which are mandatory as per MDR 2017.
We provide expert service in the development of Quality Assurance Laboratories.
Request Call Back
How Company is Different?
Diverse Platforms, Systems & Tools Expertise
Company’s IT specialists are adept at both legacy and new-age platforms, systems and tools. We, thereby, comprehend client requirements easily and swiftly devise tools and strategies to mitigate client problems
Huge Technical Proficiency
Company employs IT professionals with specialties across languages and technologies. We are, therefore, in a constant state of readiness to deploy suitable IT experts to specific client needs
Wide Industry Base
We have clients across a wide range of industries and regions around the globe. This has given us the experience and insights into the unique considerations of different organization, thereby building our best practices compendium
Swift Design & Implementation
At Company, our team of IT specialists are quick in requirement assessment, design and implementation. Backed by adequate tests and comprehensive documentation, we offer a safe net to enterprises, shortening the time-to-operate and optimizing the resources
Our IT specialists are available for round-the-clock support and maintenance services. With Company, you experience no downtime!
Cost-Arbitrage with Cost-Efficiencies
At Company, we follow flexible pricing models that take into consideration client needs and limitations. Our tailor-made pricing enables our clients to effect cost efficiencies with a huge margin. At the same time, our price-points fit in easily with client’s digital transformation budgets
It is always a pleasure to learn that the work we do has positively impacted our clients and that they are happy to share their experiences.
Have completed good work as like #company registration , #trademark registration and #gst registration
I received prompt service and accurate advice from these people. I would really recommend their services to anyone who is looking for genuine advice.
Very responsive and polite. Got my company registration in a week's time as my documentations were ready.
They are Best for Company Registration In Assam, I Just call them they did all the process on just single call, for me they are are best for Private Limited Company Registration In Assam.