CDSCO Manufacturing Licence (MD-5 / MD-9) Consultants in India

A CDSCO manufacturing licence is mandatory before any medical device or IVD made in India can be sold or distributed. Medfins International prepares your classification, Device Master File, Plant Master File and quality system evidence, files the correct MD form on the online portal, and supports you through the audit or inspection until the MD-5 or MD-9 licence is granted.

What is a CDSCO manufacturing licence?

Under the Medical Devices Rules, 2017, framed under the Drugs and Cosmetics Act, 1940, every manufacturer of a medical device or in vitro diagnostic (IVD) device for sale or distribution in India must hold a licence for each manufacturing site. Since the phased transition ended in October 2023, this applies to all risk classes, not only the devices that were earlier notified.

The CDSCO manufacturing licence is issued in one of two forms depending on risk class. It remains valid as long as the licence retention fee is paid every five years and the conditions of licence continue to be met.

Classification decides the route

Devices are classified as Class A (low risk), B (low-moderate), C (moderate-high) or D (high risk) using the risk-based rules in the First Schedule and the classification lists published by CDSCO. Getting this right first is essential, because it determines the authority, the forms and the depth of assessment.

Class A and Class B devices

• Application in Form MD-3 to the State Licensing Authority.
• Audit of the site by a Notified Body registered with CDSCO (certain low-risk Class A devices may be exempt from the pre-licence audit).
• Licence granted in Form MD-5.
• Where you use another licensed manufacturer’s facility, a loan licence is applied for in Form MD-4 and granted in Form MD-6.

Class C and Class D devices

• Application in Form MD-7 to the Central Licensing Authority (CDSCO).
• Inspection of the site by a team of Medical Device Officers, typically with State representation.
• Licence granted in Form MD-9.
• Loan licence route: Form MD-8 application, Form MD-10 licence.

Devices without a predicate, or new IVDs, need separate permission (Forms MD-26 or MD-28) and may require clinical investigation or clinical performance evaluation before a manufacturing licence can follow.

Who needs a manufacturing licence?

• Indian companies manufacturing finished medical devices or IVD kits and reagents.
• Brand owners who get devices made at a third-party licensed site (loan licence).
• Start-ups moving from prototype to commercial production, usually after a CDSCO test licence stage.
• Overseas companies setting up or acquiring a manufacturing unit in India.

Documents required

The Fourth Schedule sets out the content of the Device Master File and Plant Master File. A typical application includes:

• Constitution of the firm, proof of premises and site layout.
• Plant Master File: facilities, utilities, environmental controls, equipment, personnel and quality control arrangements.
• Device Master File for each device or group: description, intended use, design and manufacturing information, essential principles checklist, risk management, verification and validation, labelling and IFU.
• Quality management system documentation in line with the Fifth Schedule, which is closely aligned with ISO 13485.
• Details and qualifications of competent technical staff for manufacturing and testing.
• Test reports, stability or shelf-life data, sterilisation validation where applicable.
• Undertakings and proof of fee payment as per the Second Schedule.

Step-by-step process

1. Gap assessment of product, site and QMS against the Medical Devices Rules, 2017.
2. Classification and grouping of devices so that related models can be covered in one application where the rules allow.
3. Dossier preparation: Device Master File, Plant Master File and supporting records.
4. Online filing on the CDSCO medical device portal under the National Single Window System, with fee payment.
5. Audit or inspection by the Notified Body (Class A/B) or CDSCO inspection team (Class C/D).
6. Query and non-conformity closure, with objective evidence of corrective action.
7. Grant of MD-5 or MD-9, followed by post-licence obligations such as change notifications, complaint handling and materiovigilance.

Timelines and what affects them

The rules prescribe time limits for the authority at each stage, but the real driver of the overall timeline is readiness. Factors that most often decide how long a CDSCO manufacturing licence takes include:

• How mature the QMS is and whether records exist for a reasonable period of operation.
• Completeness of design, verification and validation evidence in the Device Master File.
• Availability of Notified Body or inspection dates.
• The number and quality of responses to queries raised during review.

We give every client a realistic plan based on these factors rather than a fixed promise, and we track each stage so that nothing waits on missing paperwork from your side.

Common reasons for queries and delays

• Incorrect risk class or mixing unrelated devices in one group.
• Generic, template-style master files that do not match the actual product or site.
• Missing process validation, especially for sterilisation, packaging and software.
• Technical staff whose qualifications or experience do not meet the rules.
• Labels that omit mandatory particulars required under the Medical Devices Rules.

How Medfins International supports you

Our team, led by a CQI and IRCA certified ISO 13485 Lead Auditor, has worked on more than 175 regulatory projects covering over 250 medical device products. For a manufacturing licence, we typically:

• Confirm classification and plan the licensing route and forms.
• Write or review the Device Master File and Plant Master File with your engineers.
• Set up or strengthen the QMS and train your team for the audit.
• Manage portal filing, query responses and audit follow-up.
• Support post-licence changes, new product additions and retention.

If you also plan to supply government buyers, see our GeM registration support. To discuss your device and site, contact our regulatory team.

Frequently asked questions