How to Get Medical Device Registration

 

Step 1 -Classification of Medical Devices: Medical devices shall be classified on the basis of parameters specified in the First Schedule of MDR 2017, in the following classes, namely:

1.    A is a low-risk classification.

2.    Low to moderate risk-Class B;

3.    Moderate to high risk-Class C;

4.    High risk-Class D.

Step 2: Grouping of the Medical Devices: An applicant Grouping of Medical Devices having the same or similar intended uses or commonality of technology into a single application.

Single: A Medical Device sold as a separate packaged entity that does not meet the family criteria.

Family-A Medical Device family is a collection of medical devices, each medical device being a separate medical device. The Medical Devices comprise systems that are (i) from the same license holder; (ii) intended to be used in combination to complete a common intended purpose.

Group: A Medical Device group is a collection of two or more medical devices, supplied in a single package by the same license holder.

Step 3: Choosing a Medical Device Registration Form-To manufacture a medical device or In-vitro medical device for sale or distribution, an applicant must submit an application using:

1.   Form MD-3: for Classes A and B

2.   Form MD-4: Loan License Classes A and B

3.   Form MD-7 for Class C and Class D

4.   Form MD-8: Loan License Classes C and D

5.   MD-12: Clinical Investigation/Test/Evaluation Form

Step 4: Fees for Medical Device Registration:  Requisite fees paid along with the application.

Step 5: Submitting Documents: In addition to the application and fees, an applicant must upload the detailed documentation to CDSCO's Medical Device Registration online portal.

Step 6: Inspection and License Grant

·       For Class A Medical Devices: After reviewing all documents and determining that the requirements of these rules have been met, the State Licensing Authority shall grant a licence to manufacture Class A medical devices in Form MD-5 or a loan licence in Form MD-6, as applicable.

·       For Class B Medical Devices: The State Licensing Authority shall grant a licence to manufacture Class B medical devices on Form MD-5 or a loan licence on Form MD-6, as applicable, after scrutinizing documents and audit reports and being satisfied that the requirements of these rules have been met.

·       For Class C and Class D Medical Devices: The Central Licensing Authority may, wherever required, in the case of Class C or Class D medical devices, use the services of any expert in the relevant field for scrutiny of the application and other technical documents, which shall be completed by the Central Licensing Authority within a period of forty-five days from the date of online submission of the application.

Our Services:

We have a team of Medical Device Lawyers with specialized legal expertise and extensive experience in the registration of medical devices.

Read More:- Medical Device Registration 

Location: New Delhi, Delhi, India

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