CDSCO Cosmetics Registration & Medical Device Approval

Understanding CDSCO Registration

Compliance

Is it mandatory?

Documents required

The exact checklist depends on your product and on whether you are the manufacturer, importer or brand owner. These are the documents most applications start with; we confirm your full list on the first call.

Procedure to get CDSCO Medical Device Registration

1. 1

   Device Classification

   1–3 Days

   Identify your medical device’s risk class (A, B, C, or D) and determine the applicable CDSCO licensing route.

2. 2

   Indian Agent Setup

   3–7 Days

   Foreign manufacturers arrange an Authorised Indian Agent (AIA) and the required authorisation documents for the import application.

3. 3

   Technical File Preparation

   10–20 Days

   Compile the Device Master File (DMF), Plant Master File (PMF), quality certificates, product specifications, and clinical or performance evidence, as applicable.

4. 4

   Application Filing

   2–5 Days

   Submit the relevant application through the CDSCO portal, such as Form MD-14 for imports or the applicable MD form for domestic manufacturing, and pay the prescribed fees.

5. 5

   CDSCO Review & Inspection

   Route-Dependent

   CDSCO evaluates the technical dossier and may require additional information or a manufacturing-site inspection. For import licences in Form MD-15, the CDSCO Citizen Charter lists 270 working days.

6. 6

   Licence Approval

   After Successful Review

   Obtain the applicable licence, such as Form MD-15 for imports or Form MD-5/MD-9 for domestic manufacturing, depending on the device class and licensing route.

Cost & fee structure

The total depends on your product, the number of models and the route that applies. Your written quote lists each part separately:

1. 1.Government or authority fee

   Set by the regulator or certification body, and shown in your quote at the published rate.

2. 2.Testing or audit charges

   Charged by the accredited lab or audit body where the scheme needs testing or an inspection. They depend on the product and the number of models.

3. 3.Our professional fee

   A fixed fee for preparing the file, coordinating with the lab and authority, and following up until the certificate is issued.

Validity & renewal

• Validity depends on the scheme: some approvals run for a fixed term and must be renewed before they expire, others stay valid while the product and the applicable standard stay the same.
• Changes to the product design, critical components, factory or brand name can need a fresh test or an amendment.
• We record your expiry date and remind you well before a renewal or surveillance step is due.