Introduction
The process of medical device registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare. All the medical devices must be registered with the CDSCO before they can be marketed or sold. The medical device registration process involves submitting an application and submitting supporting documents and test reports.
- The specific requirements for registering a medical device vary depending on the type and class of the device, as well as the manufacturer’s location.
- Registering your medical device in India, you will be able to legally market and sell your product in the country and have peace of mind knowing that it meets the necessary regulatory requirements.
Who can make a Submission to the CDSCO?
The applications for the registration of medical devices can be submitted by the manufacturer or their authorized representative.
- The application must be accompanied by all relevant documents, including a product brochure, test reports, and other technical documents.
- The CDSCO will review the documents and conduct an evaluation to determine if the medical device meets the regulatory requirements set by the CDSCO.
How are Medical Devices Classified?
The medical devices are classified into four categories based on the degree of risk they pose to the user: Class A, Class B, Class C, and Class D. These categories are based on factors such as the device’s intended use, design, performance, and potential harm to the user. The Central Drugs Standard Control Organization (CDSCO) is responsible for classifying medical devices in India, and it is the manufacturer’s responsibility to ensure that their products are classified correctly.
What is the time duration to register Medical Devices in India?
It takes 6 to 9 months to receive a registration certificate for medical devices in India. This clock stops when the CDSCO raises a query and restarts once the query has been responded to. New products without any strong predicates in India may take longer time and / or require a MDAC review for approval based on the recommendations by the CDSCO.
What is the Government cost of Registering Medical Devices in India?
The cost of registering a medical device in India can vary depending on the classification and risk level of the device, as well as the type of application submitted.
| Class | Fee | US $ |
Class A |
One Site ; and | $1000 |
| One Distinct Medical Device – $50 | ||
Class B |
One Site ; and | $2000 |
| One Distinct Medical Device – $1000 | ||
Class C and Class D |
One Site ; and | $3000 |
| One Distinct Medical Device – $1500 | ||
| Product without Predicate MD26 | $1000 |
Who controls the Registrations Process for Medical Devices?
The Central Drugs Standard Control Organization (CDSCO) requires the license holder or their authorized representative to ensure that imported medical devices meet the required standards and regulations, are safe and effective, and provide all relevant documentation to the relevant authorities. The document checklist is given in the following link – Morulaa
What is the ISO 13485?
EN ISO 13485 certification is provided to manufacturers who are implementing and maintaining a robust quality management system (QMS) for medical device’s manufacturing. It is a mandatory requirement for submission and approval with CDSCO.
What is Home Country Approval and is it needed?
Approval from the Home Country is preferred while making a submission in India. If not available, the foreign manufacturer needs approval from any one of the GHTF Countries such as USA, Europe, UK, Canada, Australia and Japan.
Is document translation required to make a submission to the CDSCO?
The Central Drugs Standard Control Organization (CDSCO), which is the regulatory agency in India, requires all documents to be submitted in English. If the documents are in a language other than English, the applicant needs to provide certified translations of the documents. The translations must be prepared by a qualified and competent translator and certified by a notary public or an authorized office.