Medical Devices Registration in India

Overview of Medical Devices Registration in India

Definition of Medical Device

CDSCO Medical Devices include any instrument/apparatus/appliance/ implant/material or another article, either used solely or in combination including any software or accessory designed by the manufacturer to be employed particularly for human beings or animals that don't attain the key proposed action in or on human body or animals through any pharmacologic/ immunological/metabolic means, but assists in its envisioned function:

• Regulation of conception
• Allows sustaining or support of life
• Examination, replacement or variation
• Enables disinfection of medical devices
• Support of the composition or a physiological process
• Diagnosis, prevention, monitoring, treatment or mitigation of any disease, disorder
• Diagnosis, monitoring, treatment, mitigation or assistance for any injury or disability

Some of the CDSCO medical devices that need registration in India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, dental implants, surgical sealants, heart valves, cardiac stents, orthopaedic implants, endotracheal tubes, etc.

Understanding Device Classification in India

CDSCO classifies devices using a risk-based system aligned with Global Harmonization Task Force principles, sorting products into four classes by how invasive they are and how much systemic risk they carry:

How to Register?

This is the process you need to follow while registration:

Step 1: Determine the Correct Classification

Before anything else map the device against Schedule I of the Medical Device Rules 2017 to confirm which class it belongs to. This single decision determines the form used, the authority the application goes to and how much technical data CDSCO will expect.

Step 2: Register on the SUGAM Portal

Every application manufacturing, import or registration now runs through CDSCO's Medical Device Sugam Portal (sugam.cdsco.gov.in). Create an account with a verified email and mobile number. This becomes the account used to track the filing end to end.

Step 3: Compile the Technical Documentation

The dossier typically includes:

• Device Master File (design, materials, manufacturing process, testing data)

• Plant Master File

• ISO 13485 certificate for the manufacturing site

• Free Sale Certificate, for imported devices

• Clinical evaluation data or a Clinical Evaluation Report, mandatory for Class C and D

• Labelling and Instructions for Use, formatted for the Indian market

Step 4: File the Appropriate Form

• Class A/B manufacturing: Form MD-3, reviewed by the State Licensing Authority

• Class C/D manufacturing: Form MD-7, reviewed by the Central Licensing Authority

• Import (any class): Form MD-14, filed by an Authorised Indian Agent through SUGAM

Step 5: Respond to CDSCO Queries

Deficiency letters are standard not some kind of warning that is uncommon for an application to receive. What keeps the process going is a complete response otherwise there will be another deficiency letter.

Step 6: Undergo Inspection (Where Applicable)

Class C and D manufacturing applications typically require a facility audit before approval. Import applications are generally assessed on documentation and existing regulatory approvals rather than a physical Indian-side inspection.

Step 7: Receive the License or Certificate

Once CDSCO is satisfied, it issues the relevant approval MD-5 for Class A/B manufacturing, MD-9 for Class C/D manufacturing, or MD-15 for import.

Different Categories of Medical Devices Registration

Currently, there are two different categories of medical devices for Medical Devices Registration through the SUGAM portal which have been explained below:

1. Notified Medical Devices: As of now, the CDSCO authorities have notified a list of 30+ categories of medical devices that mandatorily require registration and even require prior approval from CDSCO to market such marketing devices in India. For such devices, there are separate forms for application and different documents required to be submitted to the approving authority.

2. Non-Notified Devices: Further, other non-notified devices have not yet been notified and regulated. Thus, the registration of such devices has been made voluntary under the CDSCO SUGAM portal.

Class of Medical Device:

Who can apply for Medical Device Registration in India?

The list of individuals who can submit applications for CDSCO Medical Device Registration in India is as follows

• Domestic Importer
• Domestic Manufacturer 
• Wholesale and Retailer 
• Foreign Manufacturer's Authorized Agent
• Foreign Manufacturers Having Registered Office in India

Benefits of Medical Devices Registration

1. Meets Significant Requirements of the Indian Market: In order to address the substantial need for accessible healthcare in India, the Indian authorities are progressively depending on international manufacturers to fulfil the considerable requirement. As a result, the implementation of the medical device registration scheme becomes valuable for ensuring control and uniformity in the quality of these products.

2. Registration Monitoring and Oversight: Following registration, the Drugs and Cosmetics Act mandates manufacturers and distributors to give precedence to adhering to the provisions of the Act. This involves conducting on-site evaluations of medical devices. Manufacturers have the opportunity to aid the audit team in identifying possible concerns, thereby averting penalties for violations through product registration. This process guarantees adherence to regulations and the safety of patients.

3. Legal Protection through Compliance: Relentless pressure to maintain medical device compliance has made manufacturers worry about preparing and distributing products according to prescribed guidelines, but with medical device registration, it becomes easier.

4. Opportunities for Higher Growth & Sales: The Indian government addresses escalating demand for medical devices by allowing overseas manufacturers to enter the Indian market, ensuring compliance with CDSCO guidelines, and maintaining a high-profit margin.

5. Improve Brand Identity: The Indian market has seen a shift in manufacturers' obligations to register their products, allowing them to explore the market dynamically. However, the steep penalties make it sense not to infringe on guidelines for profit.

Application Form & Class of Medical Devices

Documents for Medical Device Registration

• Packaging description comprising pack sizes.

• Copy of the Site Master File & Plant Master File.

• Labelling details conforming to Drugs & Cosmetics Rules, 1945.

• Recommended storage conditions, Brief description of the device.

• Testing facilities are available in the manufacturing units for testing.

• Details of the Product such as Brand or Proprietary name, Device category.

•  A detailed explanation of the manufacturing process of the devices to be manufactured.

• List of accessories & other devices or equipment to be used in combination with the device.

• Copies of ISO or any other certifications, if required, obtained by the firm for its manufacturing premises.

• Details of the standards followed by the company for product examination & Good Manufacturing Practices.

• Summary of the company's plan, a device to be manufactured, their viability & other important profiles.

• Qualification, experience & name of technical staff under whose supervision the devices will be manufactured.

• Method of use and intended use, Specification of the materials used, Variations in style, size, or shape of the device, if applicable.

• Details of the applicant entity like names, addresses of the company's directors and addresses of the manufacturing units and registered offices of the Manufacturer.

CDSCO Medical Devices Registration Process

Step 1: Product Verification: The initial stage in the process of importing a medical device involves verifying whether it necessitates registration under the Medical Device Rules of 2017 and determining its classification as either a regulated or unregulated product.

Step 2: Portal Registration: After this, navigate to the online CDSCO SUGAM platform and initiate the signup procedure to acquire login credentials for website access.

Step 3: Application Submission: Submission of an application for a manufacturing license for these specified devices to the SLA using Form 27, and for the CLA through Form MD-3 or MD-7, alongside the necessary fee on the online portal.

Step 4: Scrutiny of the Application: On receipt of the application, the approving body will scrutinize the application, conduct an inspection of the manufacturing premises, and perform tests on the medical devices.

Step 5: Grant of Certificate: After which, if the approving authority is of the view that the applicant's medical device in question is genuine and manufactured in line with the pre-specified guidelines, then it may grant the registration, followed by a notification to the applicant.

Regulatory Approvals by Application Type

Depending on the device class and the applicant's role, the approval that comes out the other end differs:

A useful distinction here: MD-27 isn't a routine import approval like MD-15. It's reserved for genuinely new devices ones without a comparable product already registered in India and it typically involves a Subject Expert Committee review before CDSCO signs off.

Timeline of License Registration

The timeline for medical device license registration in India varies depending on the application type, device classification, and document completeness. Standard registrations are generally processed faster, while applications requiring detailed technical evaluation may take longer. Submitting accurate documentation and responding promptly to CDSCO queries can help expedite the approval process.

Timelines assume a complete, query-free filing. In practice, incomplete Device Master Files and classification disputes are what stretch these numbers well past the estimate a tight first submission tends to matter more than almost anything else in the process.

Cost of License

The cost of obtaining a medical device license in India depends on factors such as the type of license, device classification, number of products, manufacturing sites, and applicable government fees. Additional expenses may include testing, documentation, regulatory compliance, and consultancy services. The overall cost varies based on the complexity of the application and the regulatory pathway.

Import fees are set in USD under the Second Schedule of the Medical Device Rules and paid in INR through the Bharatkosh gateway at the prevailing exchange rate. CDSCO registration fees don't stop at the government slab either lab testing, documentation support, and Authorised Agent charges for foreign manufacturers sit outside this table and need separate budgeting.

Role of Agile Regulatory

Obtaining the Medical Devices registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire Medical Device registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.