Fee & documents required for medical device and in vitro diagnostics medical device under guidelines

All the regulatory bodies are responsible for regulations and they are trying to enhance in every step so that they can safeguard the public health and make sure efficient and technically advanced inventions reach everybody.

In India, the primary regulatory body is the Central Drug Standard Control Organization (CDSCO), which is an important part of the Ministry of Health and Family Welfare. The medical device registration India rules 2017, which came into effect in the year 2018, is the legal framework under which all medical devices and IVD devices are regulated.

But under these regulations, only some of the medical devices and IVDs need a necessary registration. According to CDSCO, the medical devices are classified into four major categories namely- Class A, Class B, Class C and Class D. Among these Class A devices are associated with the lowest risk and Class D devices fall under highest risk.

Moreover, in-vitro diagnostic devices are also further classified into certain subcategories depending upon their use. But all of them still fall under these four medical device categories.

All the applications are to be submitted through the Ministry of Health [NM1] online portal along with the required fee and the necessary documents. The application is reviewed by CDSCO and then it issues a registration certificate. The registration fees should be paid every 5 years for maintaining the certificate’s validity.

 

Fee Structure

�-�       Registration of Notified Body under Rule 13(5) - INR 25,000/-

�-�       Registration Retention Fee of Notified Body under Rule 13(7) - INR 25,000/-

�-�       Manufacturing/Loan License for Class A and B Devices under Rule 20(2) - INR 5000/- for one site and INR 500/- for each distinct medical device

�-�       Manufacturing/Loan License for Class C and D Devices under Rule 21(2) - INR 50,000/- for one site and INR 1000/- for each distinct medical device

�-�       Manufacturing/Loan License Retention fee for one site manufacturing of one device under Rule 29(1) - INR 5000/- for Class A& B and INR 50,000/- for Class C & D. 

The fee for clinical investigations, import license and overseas inspection are further defined in detail under various rules of the second schedule.

 

Documents Required for the Registration Process

�-�       Application in form MD-1 along with the below mentioned documents

�-�       Constitution details of the notified body

�-�       Brief profile of company and manufacturing sites

�-�       Accreditation Certificate as mentioned in Rule 11

�-�       Quality manual of the organization and SOP details

�-�       List of all technical personnel

�-�       An undertaking by the notified body mentioning responsibility pertaining to transparent procedures.

 

Preparing and summing up these documents can be a hectic task. So it is always better to hire a licensed medical device consultant in India for streamlining the process.

Author's Note

All the regulatory bodies are responsible for regulations and they are trying to enhance in every step so that they can safeguard the public health and make sure efficient and technically advanced inventions reach everybody.