License for Manufacturing and Import of Medical Devices

Requirements & Pathway for Grant of License for Manufacturing and Import of Medical Devices

Introduction:-

            The medical device companies interested in manufacturing and import of their products in India must comply with Medical Device Rules – 2017.

• Registration pathway for device is determined by its classification and in accordance with categories listed by CDSCO, Ministry of Health & Family Welfare from time to time

Classification of Medical Devices in India as per MDR-2017:-

 (i) Low risk – Class A;

(ii) Low moderate risk- Class B;

(iii) Moderate high risk- Class C;

(iv) High risk- Class D.

Mode of Application:

• Every application must be submitted Online by the applicant company alongwith prescribed fee and documents on SUGAM portal of CDSCO, Ministry of Health & Family Welfare.

Licensing Procedure/Pathway

For Class – A : Medical Device: (Step wise)

Application to SLA in MD form-3 alongwith prescribed fee

Submission of Plant Master File(PMF), Device Master File(DMF) and declaration of QMS compliance by manufacturer

Review by SLA
 {No prior audit by Notified Body (NB)}

Grant of License on MD Form-5 by SLA within 45 days

Audit by NB within 120 days

For Class – B: Medical Devices: (Step wise)

Application to SLA in MD form-3 alongwith prescribed fee

QMS compliance, relevant documents as per Fourth Schedule

Audit by Notified Body for QMS compliance as per Fifth Schedule

      90 days

Submission of report by NB to SLA

       30 days

 Review by SLA

       20 days

If no non-compliance

Grant of License on MD Form-5 by SLA

For Class – C&D: Medical Devices:

Application to CLA in MD form-7 alongwith prescribed fee

QMS compliance, relevant documents as per Fourth Schedule

Scrutiny by CLA

      (40 days)

Inspection by team of CDSCO Medical Device Officers and experts

      (60 days)

Submission of report by team to CLA

Review by CLA

      (45 days)

If no non-compliance

Grant of License on MD Form-9 by CLA

Procedure for Import of Medical Devices:

Application to CLA on MD form-14 alongwith prescribed fee and documents as per Fourth Schedule

Inspection of overseas manufacturing site is necessary

Grant of Import License on MD form-15 by CLA

Fees for Manufacturing and Import License:

Manufacturing:

Class A & B – Rs. 5000/-

Class C & D – Rs. 50000/-

Additional Items – Rs. 500/- per item

Import:

Class A – $ 1000

Class B – $ 2000

Class C & D – $ 3000