Who issues the medical device manufacturing license?

For Class A & B, the State Licensing Authority (SLA) issues the license. For Class C & D, it is the Central Licensing Authority (CDSCO).

Is ISO 13485 mandatory?

Yes, manufacturers must comply with the QMS requirements specified in the Medical Devices Rules, which are aligned with ISO 13485.

What is a Site Master File?

It is a document containing specific information about the quality management policies and activities at the manufacturing site.

Can I manufacture multiple devices under one license?

Yes, you can include multiple devices of the same class in a single application and license.

How long is the manufacturing license valid?

The license is permanent, subject to the payment of license retention fees every 5 years.

What is a 'Notified Body' in this context?

For Class A and B devices, a Notified Body (third-party auditor) may be involved in the audit process.

What is the penalty for manufacturing without a license?

It is a serious criminal offense under the Drugs and Cosmetics Act, leading to imprisonment and heavy fines.

How long does the process take?

Depending on the device class, it usually takes 3 to 6 months to secure the manufacturing license.

Service

Medical Device Manufacturing License

Legal assistance for medical device manufacturing licenses in India. We help with site master files, ISO 13485, and CDSCO/State filings.

Standards for Medical Production

Legal assistance for medical device manufacturing licenses in India. We help with site master files, ISO 13485, and CDSCO/State filings.

Obtain the mandatory license to manufacture medical devices in India. Ensure compliance with the Medical Devices Rules, 2017.

Innovate and produce in India. Get your manufacturing facility licensed by the CDSCO or State Licensing Authority to produce high-quality medical devices.

Manufacturing of medical devices in India is a highly regulated activity governed by the Medical Devices Rules, 2017. Every manufacturer must obtain a license before starting production, whether for low-risk items like bandages or high-risk implants like stents.

The licensing authority depends on the risk class of the device. Class A and B devices are regulated by the State Licensing Authority (SLA), while Class C and D devices are regulated by the Central Licensing Authority (CDSCO). The process involves a thorough audit of the manufacturing site and the technical documentation of the products.

QuickTaxperts provides professional support for medical device startups and established firms, managing the ISO 13485 certification, technical file preparation, and the rigorous licensing audit process.

Category: Health & Medical
Requires a Site Master File (SMF) and Device Master File (DMF).
Mandatory appointment of qualified technical and quality control personnel.
Compliance with the 'Fifth Schedule' regarding Quality Management Systems.
Enables participation in government healthcare procurement and global exports.
Mandatory for all manufacturers of medical devices and IVDs
Registration under the Medical Devices Rules, 2017
Requires a robust Quality Management System (ISO 13485)
Includes on-site audits by regulatory officers or notified bodies

Device Risk Classification

Determining your licensing authority.

Class A: Low Risk. Regulated by the State Licensing Authority (SLA).
Class B: Low to Moderate Risk. Regulated by the State Licensing Authority (SLA).
Class C: Moderate to High Risk. Regulated by the Central Licensing Authority (CDSCO).
Class D: High Risk. Regulated by the Central Licensing Authority (CDSCO).

Documents required

Document requirements vary by entity type, state, premises, and authority. These are the usual groups we verify before submission.

Manufacturing Checklist: Company Registration and PAN/GST.; Site Master File (SMF) as per regulatory format.; Device Master File (DMF) for each product category.; ISO 13485 Certificate for the manufacturing facility.; Qualification and experience certificates of technical staff.; Plant layout and machinery list.; Performance evaluation reports and clinical data (where applicable).

Process and timeline

Class ID: Identifying the correct class (A, B, C, or D) for the proposed medical devices.
ISO 13485: Implementing a Quality Management System and obtaining the ISO 13485 certification.
Online Filing: Submitting the application on the SUGAM portal (Form MD-3/MD-7).
Audit: Undergoing an on-site inspection by the drug inspector or a notified body.
Review: Responding to technical queries from the state or central authority.
License Grant: Receiving the Manufacturing License in Form MD-5 or MD-9.

Expert review

Medical Device Manufacturing License content is reviewed by QuickTaxperts Medical Regulatory Team, Industrial Compliance Experts.

Checklist-led review
Document pre-verification
Authority-specific next steps

Frequently asked questions

These quick answers cover common planning questions before you request a checklist or quote.

Who issues the medical device manufacturing license?: For Class A & B, the State Licensing Authority (SLA) issues the license. For Class C & D, it is the Central Licensing Authority (CDSCO).
Is ISO 13485 mandatory?: Yes, manufacturers must comply with the QMS requirements specified in the Medical Devices Rules, which are aligned with ISO 13485.
What is a Site Master File?: It is a document containing specific information about the quality management policies and activities at the manufacturing site.
Can I manufacture multiple devices under one license?: Yes, you can include multiple devices of the same class in a single application and license.
How long is the manufacturing license valid?: The license is permanent, subject to the payment of license retention fees every 5 years.
What is a 'Notified Body' in this context?: For Class A and B devices, a Notified Body (third-party auditor) may be involved in the audit process.
What is the penalty for manufacturing without a license?: It is a serious criminal offense under the Drugs and Cosmetics Act, leading to imprisonment and heavy fines.
How long does the process take?: Depending on the device class, it usually takes 3 to 6 months to secure the manufacturing license.