Who Can apply for the retention of medical device manufacturing license in Form MD-9 in India?

Any person intending to manufacture Class C and Class D medical devices.

Government fee for permission for medical device manufacturing permission retention in India?

The fees required for the manufacturing license for: One site manufacturing Class C or Class D medical device – INR 50000 Each distinct medical device of Class C or Class D – INR 1000

BIS Certification For Manufacturer (ISI Mark) In India?

The regulatory body to provide the certification scheme to domestic manufacturers for products conforming to the Indian Standards under Scheme - I is the Bureau of Indian Standards (BIS). There are 2 options for obtaining the certification scheme for products conforming to the Indian Standards under Scheme – I. The application must be made in Form V, as specified in the Bureau of Indian Standards (BIS) (Conformity Assessment) regulations 2018 – Scheme I, along with the required documents as per Form V.

Who can apply for ISI Mark BIS Manufacturer Registration in India?

The products manufactured must conform to the Indian Standard Specifications (ISS). Domestic manufacturers manufacturing products which come under mandatory certification by the Central Government as per the Provision of the Bureau of Indian Standards (BIS) Act 2016 or other Acts.

How to apply for BIS certification for manufacturers (ISI Mark) in India

there are 2 options for obtaining the certification scheme for products conforming to the Indian Standards under Scheme – I. The application form (Form V), along with the required documents must be submitted. Only online applications (including payment) for obtaining the certification scheme for products conforming to the Indian Standards under Scheme – I are accepted by the Bureau of Indian Standards (BIS). The Bureau of Indian Standards (BIS) grants the certification based on successful assessment of the manufacturing infrastructure, quality control, process control and testing capabilities of the manufacturer. The conformity of the product to the relevant Indian Standard(s) is established via testing in the manufacturing premises or via third-party laboratory testing or both.

Retention of Manufacturing License for Class C and D Medical in India - MD 7 & MD 9

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Retention of Manufacturing License- Form MD 7/9 (Class C & D) – Overview

The regulatory body responsible for retention of manufacturing license (Class C and Class D) is the Central Drugs Standard Control Organisation (CDSCO). This service is required to retain the manufacturing license of Class C and Class D medical devices granted in Form MD 9. Any person who intends to retain their manufacturing license (MD 9) shall make an application to theCentral Drugs Standard Control Organisation (CDSCO) through an online portal of the Ministry of Health and Family Welfare in the Central Government.

Who Can Apply?

Any person intending to manufacture Class C and Class D medical devices.

How To Apply?

The Applicant must follow the following process:

It has to be applied to the Central Drugs Standard Control Organisation (CDSCO) through an online portal of the Ministry of Health and Family Welfare in the Central Government.

Validity

The license issued in Form MD 9 shall remain valid in perpetuity before the completion of the period of 5 years, provided that the manufacturing license retention fee has been paid as per the Second Schedule. The above is not applicable if the license has been cancelled or suspended by the Central Drugs Standard Control Organisation (CDSCO).

Fee Involved

The fees required for the manufacturing license for:

One site manufacturing Class C or Class D medical device – INR 50000
Each distinct medical device of Class C or Class D – INR 1000

Important Documents

A copy of the existing manufacturing license (MD 9) for which retention is applied.

An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Plant Master File (PMF) and Device Master File (DMF).

Documents stating the qualifications, experiences and responsibilities of current competent technical staff.

Timeline to get MD 9 from Central Drugs Standard Control Organisation

1 to 2

MONTHS

Essential Tips

The documents required for the manufacturing license (Class C and Class D) application, preparation and submission are:

A copy of the existing manufacturing license (MD 9) for which retention is applied.
Post marketing surveillance data (Details of complaints, AEs, SAEs, sales, Recall, CAPA, if any)
Documents stating the qualifications, experiences and responsibilities of current competent technical staff.

Expert Advise

An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Constitution of the Firm must be submitted.

An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Plant Master File (PMF) and Device Master File (DMF) also must be submitted.

The license holder needs to pay the manufacturing license retention fee on or before the due date.

Frequently Asked Questions

Can the license holder pay the manufacturing license retention fee after the due date?

If the license holder pays the manufacturing license retention fee after the due date, then they must pay a late fee calculated at the rate of 2% of the manufacturing license retention fee for every month or part thereof, within 180 days, along with the manufacturing license retention fee.

Is post marketing surveillance data required for the retention of the application?

Yes, the post marketing surveillance data is required.