1. MD-42 Wholesale License (For Distribution and Retail Sale)

If your business involves selling or distributing surgical tools to hospitals, clinics, or retailers, you must apply for the MD-42 License.

• This license is issued by your State Licensing Authority.
• It is mandatory for all businesses that sell Class A and Class B medical devices, which include many common surgical tools.
• You must have proper storage facilities and qualified staff (like a registered pharmacist or a science graduate) to get this license.

Why it’s important: Without MD-42, you can’t legally store or sell surgical equipment in India.

2. CDSCO Medical Device Registration (Under MDR, 2017)

Most surgical tools are classified as medical devices under the Medical Devices Rules, 2017. 

You need to register them with CDSCO, depending on their risk classification:

• Class A and B devices (low to medium risk) can be self-certified but still require registration.
• Class C and D (higher-risk) devices need more documentation and approval from the CDSCO officers.

To register:

• Visit the CDSCO SUGAM Portal
• Submit details of your products, technical data, and quality certifications (like ISO 13485).

Why it’s important: Without this registration, your products can be seized or banned during inspection.

3. MD-15 Drug Import License (If Importing Surgical Equipment)

If you’re importing surgical tools into India, you must obtain the MD-15 Import License from CDSCO.

• The license is issued to an Indian Authorized Agent who will act on behalf of the foreign manufacturer.
• You need to submit documents like the Free Sale Certificate, Plant Master File, Device Master File, and test reports.

Why it’s important: Customs authorities will not clear your goods without this license.

Summary of Mandatory Licenses

Getting the right licenses not only keeps your business legal but also builds trust with hospitals, clinics, and government buyers. 

It is always advised to consult a CDSCO-approved consultant or a legal advisor to avoid delays or penalties.

2. How do I know if my surgical tools require CDSCO registration under Medical Device Rules, 2017?

To find out if your surgical tools require CDSCO registration under the Medical Device Rules, 2017, you need to understand two things:

1. How devices are classified, and
2. Which ones need mandatory registration now?

Let’s break it down step by step.

What Are Class A and Class B Surgical Devices?

Under the Medical Device Rules (MDR), 2017, surgical tools are divided into risk-based categories:

If you sell common surgical tools like scalpels, scissors, sutures, or diagnostic tools like BP monitors or stethoscopes, they are likely Class A or B devices.

CDSCO Mandatory Registration for Class A & B

Earlier, only Class C and D needed CDSCO approval. But now, as per the latest notification, Class A and Class B devices also require mandatory registration on the CDSCO SUGAM portal.

Since October 1, 2022, it is compulsory to register all Class A and B devices before selling them in the Indian market. 

This applies to both importers and local manufacturers/distributors.

How to Check if Your Device Needs Registration

Here’s how you can find out if your product is listed:

1. Visit the CDSCO portal: https://cdsco.gov.in
2. Look for the List of Notified Medical Devices under the “Medical Device” section.
3. Search for your product name or category.
4. Check the classification (A, B, C, or D).
5. If your device is in Class A or B, registration is now mandatory.

What You’ll Need for CDSCO Registration (Class A/B)

• Name and type of the surgical tool
• Manufacturer details
• ISO 13485 certification (quality standard)
• Free Sale Certificate (if imported)
• Product label and technical documents

After applying through the SUGAM portal, you will receive a registration number. 

This number must be printed on the label before selling the product.

Key Tip for Healthcare MSMEs

Many small clinics and healthcare MSMEs buy Class A/B surgical tools regularly. 

If you plan to sell to them, ensure your products are registered. 

Buyers now ask for CDSCO compliance to avoid legal issues during inspections or tenders.

In short, if your surgical tool is classified as Class A or B, you must register it on the CDSCO portal. It’s the law, and it helps your business appear professional and trustworthy.

3. What is the process to get ISO 13485 certification, and why is it important for MSMEs selling surgical equipment?

Getting ISO 13485 certification is an important step for any MSME that wants to sell surgical equipment in India. 

It shows that your business follows proper quality systems for handling and selling medical devices.

Let’s understand this in simple steps:

What is ISO 13485?

ISO 13485 is a global quality standard for businesses that manufacture, store, or distribute medical devices like surgical tools. 

It ensures that your processes are safe, consistent, and meet both Indian and international compliance standards.

For healthcare MSMEs selling surgical equipment, this certificate builds trust and opens more business opportunities.

Why is ISO 13485 Important for MSMEs?

1. Government Approval: Many tenders from hospitals or government bodies require ISO 13485.
2. CDSCO Readiness: It is a must-have for CDSCO registration of most surgical tools (especially Class B and above).
3. Audit Proof: Helps you stay ready for inspections from State Drug Authorities or the CDSCO.
4. B2B Sales Growth: Big buyers like hospital chains or export clients often prefer ISO-certified vendors.
5. Quality Consistency: It improves how you store, package, and handle sensitive equipment.

Step-by-Step Process to Get ISO 13485 Certification

Here is a simplified guide:

Step 1: Hire a Certification Consultant

Look for an ISO 13485 consultant who can help you understand the documentation and setup needed. 

Many MSMEs take help from local agencies or online platforms.

Step 2: Gap Analysis

The consultant will check your current business setup, how you store products, how records are kept, packaging standards, etc., and tell you what needs to improve.

Step 3: Documentation

Prepare a Quality Manual, Standard Operating Procedures (SOPs), storage records, cleaning logs, delivery tracking, and recall procedures.

Step 4: Implement QMS

Make sure your employees follow these procedures every day, especially in stock handling, storage, and delivery.

Step 5: Internal Audit

Your consultant or team will run a test audit to check if everything is in place.

Step 6: Apply for ISO Audit

Choose an accredited certification body (like TUV, BSI, Intertek, SGS, etc.) and request an audit.

Step 7: External Audit

An auditor will visit your office or warehouse. They will review your records, inspect processes, and check compliance.

Step 8: Certification Issued

If everything is in order, you will receive your ISO 13485 certificate, valid for 3 years. Annual surveillance audits are done to ensure ongoing compliance.

Cost Estimate for MSMEs

• Small Distributor or Wholesaler: ₹60,000 to ₹1.2 lakh
• Mid-size Unit with Warehouse: ₹1.5 lakh to ₹2.5 lakh

The cost depends on your team size, location, and the scope of products handled.

Final Tip

If you’re an MSME planning to scale your surgical equipment business, ISO 13485 is not optional anymore. 

It’s a must-have for registration, exports, tenders, and long-term growth.

Getting this certification early gives you an edge over local competitors who still operate informally.

4. How should surgical equipment be labeled and packaged to comply with India’s Legal Metrology Act?

To sell surgical equipment legally in India, every item must follow proper labeling and packaging rules under the Legal Metrology Act, 2009. 

These rules ensure that healthcare MSMEs give complete and correct product information to buyers like hospitals, clinics, and distributors.

Let’s break this down in a simple way.

Why Labeling and Packaging Matter

When you’re selling surgical tools, your product isn’t just judged by its use; it’s also judged by how clearly and legally it’s labeled. 

The Legal Metrology Act ensures fair trade practices and protects the end-user (like doctors and clinics).

Mandatory Labeling Details (on Primary Packaging)

Every surgical tool you sell, whether it’s a scissor, forceps, or thermometer, must have these details printed on the outer package or label:

1. Name and Address of Manufacturer or Importer
   • This helps buyers trace the origin of the product.
   • For imported tools, mention the authorized Indian importer.
2. Country of Origin
   • Especially for imported items, write “Made in Germany” or “Made in China” if applicable.
3. Product Name and Description
   • Clearly mention the tool name, e.g., “Surgical Dressing Scissors – 6 inch – Stainless Steel”.
4. MRP (Maximum Retail Price)
   • Must include all taxes. Write clearly: “MRP: ₹450 (Incl. of all taxes)”.
5. Batch Number or Lot Number
   • Important for quality control and tracking in case of recalls.
6. Date of Manufacture
   • Mention the month and year of production (e.g., MFD: 02/2025).
7. Expiry Date
   • For sterilized or disposable products like syringes, gloves, sutures, mention clearly: “EXP: 02/2028”.
   • Reusable tools may not have expiry dates, but must mention re-sterilization guidelines.
8. Quantity
   • Mention the number of items in the pack (e.g., “Contains: 10 pcs”).
9. Customer Care Details
   • Helpline number, email, and office address for complaints or inquiries.

Optional But Useful Details

• Storage Conditions (if needed): “Store below 30°C in a dry place”.
• Sterility Indicator: “Sterile – Do not use if pack is damaged”.
• License Number: Mention the CDSCO license or MD-42 number, especially for Class B surgical tools.

Packaging Guidelines for Healthcare MSMEs

1. Use Tamper-Proof Packaging
   • Ensure it’s sealed properly to prevent contamination.
2. Sterile Products should be packed in blister pouches or sterilized wraps with expiry and lot details.
3. Bulk Packs for hospitals must also carry the same labeling, either on each unit or on the main carton.
4. Durable Material: Use boxes or pouches that can withstand transportation and storage.

Penalties for Non-Compliance

Not following labeling laws can lead to:

• Fines starting from ₹25,000 and going up to ₹1 lakh
• Product recalls or seizures during inspections
• Blacklisting from government or private tenders

Final Tip

If you’re planning to supply surgical tools to small clinics, hospitals, or distributors, make sure your packaging is clear, professional, and legally compliant. 

Good labeling builds trust and helps you avoid legal trouble.

Always check updates from the Legal Metrology Department and CDSCO to stay fully compliant.

5. What documents are required to apply for a surgical device wholesale or import license in India?

To legally sell or import surgical tools in India, you must apply for the correct licenses under the CDSCO and state drug departments. 

If you’re a Healthcare MSME, especially planning wholesale or import operations, the most common license you’ll need is the MD-42 Wholesale License.

Here’s a simple breakdown of the important documents you’ll need to prepare and submit.