CDSCO

Obtaining a CDSCO license for medical device registration in India is a complex and time-consuming process. It requires extensive documentation and expertise in regulatory compliance.

Classification of MedicalDevices in India

Class A (Low Risk)

Bandages, surgical masks

Class B (Moderate Risk)

Syringes, nebulizers

Class C (High Risk)

Implantable devices, pacemakers

Class D (Highest Risk)

Heart valves, life-supporting equipment

Medical Device Registration Process

Classification & Documentation

Devices are categorized based on risk, and applicants must prepare technical documents, compliance certificates, and regulatory approvals.

Application Submission

The application, along with the required documents, is submitted via the CDSCO portal. Registration fees must be paid at this stage.

Review & Inspection

CDSCO evaluates the application, reviews documents, and may conduct facility inspections for quality assurance.

Approval & Licensing

Upon meeting all compliance requirements, CDSCO grants the necessary license for sale and distribution.

Manufacturing License Requirements

Obtaining a Manufacturing License for Class A & B devices (regulated by the State Licensing Authority) and Class C & D devices (regulated by the Central Licensing Authority).

Providing required documents such as a Site Master File, Device Master File, ISO 13485 certification, and manufacturing process details.

Registering on the CDSCO Sugam portal and submitting MD-3 & MD-7 forms for approval.

Form MD 5

Manufacturing medical devices require adherence to strict regulations set by the Central Drug Standard Control Organisation (CDSCO). At AccorpMed, we guide manufacturers through the licensing process for Class A and Class B medical devices, ensuring full compliance with regulatory requirements.

CDSCO Licensing Process

Gather Required Documents

Before applying, the manufacturer must gather key documents like a cover letter, proof of location, firm details, test license, and quality control data.

Submit Application

Apply through FORM MD-3 to the State Licensing Authority for manufacturing, sales, or distribution approval.

Document Review

Authorities review submitted documents and verify compliance with CDSCO standards.

Manufacturing Site Inspection

For Class B medical devices, an inspection of the manufacturing site is conducted to assess safety and quality standards.

License Approval

Upon successful review, the State Licensing Authority grants FORM MD-5, allowing legal manufacturing and distribution of medical devices.

Form MD 9

The Central Drugs Standard Control Organisation (CDSCO) regulates the manufacturing of Class C & D medical devices in India. To manufacture, sell, or distribute these devices, companies must obtain a Form MD-9 license by applying through Form MD-7 under the Medical Device Rules, 2017.

Application Process MD 9

Submit Application

Manufacturers must apply to the Central Licensing Authority via Form MD-7 through the government's online portal.

Document Submission

The application must include a cover letter, plant master file, device master file, firm constitution details, site ownership proof, quality certificates, test licenses, and an undertaking confirming compliance with the Fifth Schedule of Medical Device Rules.

Review & Inspection

CDSCO reviews the application and may conduct a manufacturing site inspection through a Notified Body or Medical Device Officers to ensure compliance.

Manufacturing Site Inspection

For Class B medical devices, an inspection of the manufacturing site is conducted to assess safety and quality standards.

License Approval

Upon successful verification, the CDSCO grants the Form MD-9 license, allowing the legal manufacturing, sale, and distribution of Class C & D medical devices.

Test Licence

Manufacturing small quantities of Class A, B, C, or D medical devices for testing, evaluation, research, or training in India requires a Test License (Form MD-13) from CDSCO. To obtain this, applicants must submit Form MD-12 through the Ministry of Health and Family Welfare's Sugam portal.

Documents Required for est Licence

Medical device description (intended use, design, materials).
List of qualified personnel.
Quality certifications.
Equipment details & premises schematic plan.

Application Process Test Licence

AccorpMed streamlines medical compliance with expert licensing and certification solutions. Trusted by 100+ healthcare businesses, we ensure hassle-free approvals for land, product, labor, and distribution licenses.

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