What is Class A NSNM Registration?

Class A NSNM refers to Class A Non-Sterile, Non-Measuring medical devices as per the Medical Device Rules, 2017 issued by the Ministry of Health and Family Welfare, India. These devices are considered low-risk and are not involved in measurements or sterilization. Despite their low-risk categorization, these devices require formal registration with CDSCO before they can be marketed in India.

Devices That Fall Under Class A NSNM Include:

• Surgical gloves (non-sterile)
• Bandages and gauze
• Tongue depressors
• Cotton swabs
• Thermoplastic splints (non-measuring)
• General surgical instruments not used for measurement or requiring sterility

If your product falls under this classification, proper registration is mandatory to ensure compliance with Indian medical device regulations.

Why Class A NSNM Registration is Crucial

Even though Class A NSNM devices are low-risk, their compliance is strictly monitored by regulatory authorities. Non-compliance can result in legal penalties, market bans, and brand reputation damage. Registration is essential to:

• Legally market and distribute Class A devices in India
• Demonstrate product quality and safety to distributors and end-users
• Comply with import/export policies involving Class A devices
• Build trust with hospitals, clinics, and other healthcare providers

How Rico Solutions India Private Limited Assists You

We understand how critical it is to get things right the first time. With a team of dedicated regulatory professionals, Rico Solutions offers end-to-end assistance for your Class A NSNM Registration under the CDSCO framework.

Our Comprehensive Services Include:

1. Device Classification & Eligibility Assessment
   • We help confirm whether your device qualifies as a Class A NSNM under Indian regulations.
2. Document Preparation
   • Preparation of documents such as the Free Sale Certificate, ISO 13485 certificate, Device Master File (DMF), and Plant Master File (PMF) where applicable.
3. Form Registration of Non Regulated devices .
   • Online application submission using Form MD-5 as per CDSCO guidelines.
4. Authorized Indian Agent (For Foreign Manufacturers)
   • If you are a foreign manufacturer, we act as your authorized agent in India and handle all registration processes on your behalf.
5. Follow-ups & Clarifications
   • We liaise with the CDSCO officials to respond to queries and ensure timely registration.
6. Post-registration Compliance
   • We guide you on labeling, shelf-life, distribution norms, and ongoing regulatory updates to keep you compliant even after registration.

Timeline for Class A NSNM Registration

The registration of Class A devices typically takes at same day from the date of complete application submission, depending on CDSCO workload and documentation accuracy. With our team, you can avoid unnecessary delays and fast-track your registration.

Why Choose Rico Solutions for Medical Device Regulatory Services?

 Proven Track Record
Over the years, we have helped numerous manufacturers, both Indian and international, successfully register their Class A NSNM medical devices in India.

 In-Depth Regulatory Knowledge
Our team stays updated on every amendment in India’s Medical Device Rules, ensuring your submissions are always in line with current requirements.

 Customized Approach
Every medical device is unique. Our consultants assess your specific product and provide personalized guidance throughout the registration lifecycle.

 Affordable & Transparent Pricing
No hidden charges. We provide a clear fee structure before initiating the process.

Additional Services by Rico Solutions

• Medical Device Import License
• Medical Device Manufacturing License
• In Vitro Diagnostic (IVD) Device Licensing
• Post Approval Changes (Form MD-6)
• Test License for Import/Manufacturing (Form MD-16)
• Device Endorsements for multiple models/variants
• Class B, C, and D device licensing

Get Started Today

Whether you’re a domestic manufacturer or an overseas company planning to enter the Indian market, Rico Solutions India Private Limited is your trusted partner for Class A NSNM Registration and complete medical device regulatory support.

 Contact us today to discuss your product and get started with a smooth, compliant, and timely registration process.