Presently, the regulations for medical devices in India are still evolving. Only a select few products need a medical device permission to be launched. In the past few years, there have been three major announcements outlining the medical device products that need to be registered.
Up to 2005, only medical devices such as disposable hypodermic syringes, condoms, tubal rings, metered dose inhalers (MDIs), etc., had to be registered in India. Beginning March 1, 2006, items such as cardiac stents, catheters, intraocular lenses, bone cement,drug eluting stents, also must be registered for import, manufacture and sale. Further, on March 20, 2009, the Central Drugs Standard Control Organization (CDSCO) ratified that sterile medical equipments such as spinal needles, extension tubes, endotracheal tubes, and cardiac patches must also be registered.
India is a huge and growing market for all healthcare products. Thus, an increasing number of foreign medical equipment companies are expected to venture and import their products. With this, even the regulatory situation on licenses and medical device registration in India is evolving continuously, and companies need to stay up-to-date in order to achieve success in India. With our assistance and up to date regulatory data base, our clients can plan and meticulously execute their projects in India.
Medical device regulation is still not completely defined in Indian regulations; hence, understanding the product and executing projects is a huge challenge .We at CliniExperts develop proper regulatory strategy and share it with our clients, which help build support for the strategy and ensure that CliniExperts held to its promise of executing the projects.
Application for the grant of license for manufacture of notified or non-notified devices must be made to the State Licensing Authority (SLA) or Central Licenses Approving Authority (CLAA) depending upon product categorization, accompanied by the requisite fee in the manner prescribed in the Rules along with a copy to the office of DCG(I).
The permission to manufacture any new medical device in India consists of three main forms- Form 29, Form 44 and Form 46.
Form 29 is a license to manufacture devices for the purpose of Examination Testing and Analysis and holds validity for one year.
Form 44 is an application for grant of permission to manufacture a New Medical Device.
Form 46 is Permission/Approval for manufacture of a new medical device.
We assist our clients in obtaining the permission successfully from the respective authorities enabling them to begin hassle free manufacturing.
In India, application for the grant of licence for manufacturing Medical Devices is made in Form 27. It is for the grant or renewal of an existing licence to manufacture for sale or for distribution of devices specified in Schedules C and C (1). It is obtained from Central Licences Approving Authority (CLAA) in Form 28.
We provide end-to-end regulatory support to our clients in obtaining the required manufacturing license easily.
We can obtain manufacturing license for Non-Notified Medical Devices from SLA for our clients. We have presence in almost all states of India enabling us to effectively liaison with State FDA/ State Licensing Authority (SLA) for hassle free communication and license obtaining.
MDAC/SEC Meetings are important for categorizing medical devices in non-notified category as there is a fine line of difference. We also represent our clients in the MDAC/SEC meeting.
The devicesthatare not listed under the Notified devices list as per the D&C Act, 1940 and Rules, 1945, require a clarification letter from CDSCO is required for its registration/clarification.
In some cases, for Class II and III devices, even if not classified in the notified devices category, the devices must be registered through this clarification letter.
We help our clients in preparing and submitting the letter for clarification to CDSCO.
The approval for device largely depends on the rationale and justification for using it. In line with the regulations at CDSCO, all cases of New Devices, Global Clinical Trials etc. are discussed by the MDAC/SEC committee of the respective therapeutic branch before the sponsor before granting an approval. CliniExperts have the capabilities to represent sponsor at the MDAC/SEC meeting. We can also evaluate sponsor’s proposal and can guide them to handle their cases at the at MDAC/SEC meeting.