Guide to the import of medical devices and medicine into India

However, the process of importing medical products from other countries to India is far from simple. From medical devices to medicine import, there is the logistical challenge of shipping temperature sensitive products. Furthermore, there is import duty and a long list of documents required for import customs clearance that importers need to prepare for.

This guide provides a detailed overview of the key considerations for the smooth import of medical devices in India and highlights how the right logistics partner can make all the difference.

Key import lanes for medical products to India

India's medical device and pharmaceutical market is one of the fastest-growing globally, with significant demand met through imports. While the country is expanding its domestic manufacturing, it remains highly reliant on a diverse range of international partners for high-quality, high-tech medical products. The following countries represent India's key import lanes for medical goods.

Medical imports from the US to India

The United States is a key partner in India's medical sector, supplying advanced medical instruments, diagnostic imaging equipment, and complex surgical apparatus. India's reliance on imported medical devices is significant, with nearly 70% of its medical device market demand being met by foreign suppliers.

Reflecting this growing partnership, medical device exports from the US to India have surged by 66.3% from 2020 to 2024¹, a testament to the rising demand for high-end technologies. This strong trade relationship is also highlighted by the fact that medical equipment and pharmaceuticals are the third-highest export from the US to India in 2025². Furthermore, according to the Hindustan Times, the Indian government is considering cutting tariffs on the import of medical devices in India from the US³, which would further facilitate this crucial trade lane.

Medical imports from China to India

China is a trade lane that is important to the import of low-cost medical devices and pharmaceutical ingredients for medicine into India. This includes a wide range of products, such as consumables, surgical instruments, and Active Pharmaceutical Ingredients (APIs), which are essential for India's own pharmaceutical manufacturing industry. According to Pharmabiz, China accounts for almost 72% of bulk drug imports into India⁴.

Medical imports from Germany to India

Germany is a significant trade partner when it comes to the import of medical devices in India, specializing in high-quality, precision-engineered medical equipment. German companies are globally renowned for their expertise in manufacturing sophisticated diagnostic tools and surgical instruments. This makes them a trusted partner for India's hospitals and healthcare facilities, which are increasingly investing in advanced technology.

Regulatory bodies for medical imports in India

Regulations for India’s medical and pharmaceutical sector are overseen by several key bodies.

• The Central Drugs Standard Control Organization (CDSCO): The CDSCO is the national regulatory authority for drugs and medical devices. Its primary function is to ensure the quality, safety, and effectiveness of these products. It is responsible for issuing all critical approvals, including the import license for medical devices in India, and conducting inspections.
• Ministry of Health & Family Welfare: This ministry sets the overarching health policies and standards that govern all aspects of healthcare in the country. The CDSCO operates under its direction.
• State Drug Control Authorities: These bodies work at the state level to enforce regulations and manage local licensing and compliance.

Necessary import licenses for medical imports in India

Obtaining the correct import licenses is the single most important step in the import process for medical goods entering India. Without them, your shipment will face significant delays or even be seized.

Here are the necessary licenses and registrations you should be aware of before shipping medical supplies, devices or any form of medical goods to India.

1. Registration Certificate for Foreign Manufacturers (Form 41)

• Purpose: This certificate validates the foreign manufacturing site and the specific products intended for import. It is a prerequisite for applying for an import license.
• Details: The CDSCO evaluates the quality and safety parameters of the manufacturing site and its products before issuing this certificate in Form 41. It must be obtained by the foreign manufacturer, often with the assistance of an authorized Indian agent and is valid for three years.

2. Import License for Drugs (Form 10)

• Purpose: This license grants the legal right to import and sell specific drugs into India.
• Details: To import drugs that are not classified under Schedule X of the Drugs and Cosmetics Rules, an application is submitted in Form 8, and the license is granted in Form 103. The license is typically valid for three years.

3. Medical Device Import License (MD-15)

• Purpose: The MD-15 import license is mandatory for importing and selling all classes of medical devices (Class A, B, C, and D) in India and is granted by the CDSCO.
• Details: The application for this license is submitted in Form MD-14, and the license is issued as MD-15 by the CDSCO4. For a foreign manufacturer, the application must be submitted through an authorized Indian agent. It is valid for a period of five years.

All these licenses and registrations are processed through the CDSCO's online portal.

Customs clearance for medical imports

One of the most complex aspects of international shipping is customs clearance. A single missing or incorrect document can lead to long delays and added costs. Proper preparation is essential to ensure your shipment clears customs without delay.

Essential customs documents for medical imports

To ensure a smooth customs process, you'll need a comprehensive set of documents required for import customs clearance, including but not limited to:

• Commercial invoice: A detailed record of the transaction.
• Packing list: A list of the contents of each package.
• Air waybill: The contract of carriage between the shipper and the airline.
• Certificate of Analysis (CoA): Confirms that the pharmaceutical product meets its specifications.
• Certificate of Pharmaceutical Product (CPP): A certificate verifying a drug’s compliance with good manufacturing practices.
• Import licenses: Relevant drug import license and other CDSCO approvals.
• Bill of entry: A document submitted to customs authorities to declare the goods.
• Importer Exporter Code (IEC): A unique business identification number.

• HS codes for pharmaceutical products and medical equipment

The HS code is a globally standardized system for classifying traded goods. It's a six-digit number used by customs authorities worldwide to identify products for duties, taxes, and statistics. 

While the first six digits are universal, individual countries like India can add more digits for further classification, resulting in an 8-digit or 10-digit code. In India, this is known as the Harmonized System of Nomenclature (HSN).

The correct hs code for pharmaceutical products and hs code for medical equipment is vital for accurate valuation and to prevent customs disputes. Most medical imports from the US to India will fall under these two HS chapters.

• Chapter 30: Pharmaceutical Products This chapter covers a wide range of goods, including prepared medicaments, vaccines, antisera, and blood fractions. The codes under this chapter are used for anything from medicinal preparations to sterile surgical catgut. 
• Chapter 90: Instruments and Apparatus This chapter is for medical equipment. It includes a vast array of instruments and appliances used in medical, surgical, dental, or veterinary sciences. This includes everything from diagnostic apparatus to surgical tools and furniture. 

• Packaging and handling requirements for medical imports

Medical products are not typical cargo. Advanced medical devices and pharmaceuticals must be handled with the utmost care to preserve their integrity and functionality during transit. These are some of the unique logistical considerations for medical 

Many pharmaceutical and biological products are highly sensitive to temperature fluctuations. When shipping temperature sensitive products, they may need to be kept within specific temperature ranges to remain stable and effective, whether refrigerated (2°C to 8°C), frozen (-20°C or colder), or at controlled room temperature (15°C to 25°C).

Temperature controlled logistics relies on a proven cold chain logistics system that utilizes:

• Specialized temperature controlled shipping packaging like insulated containers.
• Temperature-controlling elements like gel packs or dry ice.
• Monitoring solutions such as data loggers that provide real-time temperature readings throughout the journey.

Make DHL Express your partner for medical imports from the US to India

For companies engaged in medical imports, a logistics partner is a critical part of the supply chain, and in the high-stakes world of pharmaceuticals and medical devices, you need a partner you can trust.

DHL Medical Express is an international shipping service specifically designed for the unique challenges of the life sciences and healthcare sectors, providing comprehensive cold chain solutions and a global network with extensive customs expertise in both the US and India.

Trust DHL Express to be your ideal partner for shipping medical supplies and ensuring your products reach their destination in optimal condition. To get started, simply create a DHL Express business account with us today.