The demand for surgical instruments in India is high. Hence, medical device companies are focusing on surgical instruments. However, there are various requirements that you have to fulfil to secure a surgical instrument wholesale license. In this blog, we have curated a detailed guide on how to start a surgical instruments wholesale business in India. Additionally, we have mentioned the various criteria requirements for securing a surgical instrument wholesale license in India.

What are surgical instruments?

Surgical instruments are basically hand-held equipment or electrically-powered tools used by clinicians to perform various surgeries. A variety of instruments are used in an operating suite. The nature and complexity of the surgical procedures determine the type of instruments required. The instruments not only vary in type but also vary in sizes. Additionally, they are usually made of carbon steel, aluminium, stainless steel, or titanium. Over the years, these instruments have been refined and modified to suit the needs of the surgeons. Additionally, they are constantly being developed to cater to the needs of the various ever evolving surgical procedures.

Demand for surgical instruments in India

The first question that comes to our mind is will a surgical instruments wholesale business in India be profitable. To answer this, we have provided insights into the Indian surgical instruments market.

With advancement in surgeries performed in India, minimally invasive surgeries, robotic surgeries, and other surgical technologies, the Indian surgical instruments market is booming. The Indian surgical instruments market can be categorised into the following segments: type of equipment (laparoscopic instruments, electro surgical instruments, handheld instruments, etc.), application (orthopaedic, cardiology, neurology, etc.), and end-user. The growth of this market segment is being fuelled by increase in number of surgeries being performed in India owing to increase in healthcare spending, government support, and number of accidents and injuries. Additionally, rise in prevalence of chronic diseases and demand for minimally invasive surgeries that require specialised surgical instruments are also driving the growth of this market.

Thus, the demand for surgical instruments in India is poised for considerable growth in the foreseeable future. Several factors are and will be contributing to this growth. A large population, significant healthcare needs, and increase in healthcare expenditure are all contributing to the increase in demand for surgeries. Moreover, India’s healthcare infrastructure, supported by government initiatives and increased healthcare spending, is continuously and steadily improving. Additionally, key market players are investing in the Indian market by introducing innovative surgical equipment and tools. All these factors in turn are driving the rise in demand for surgical instruments in India.

An overview of the Indian surgical instruments market segments:

Type of equipment or instrument

• Surgical sutures and staplers
• Handheld surgical instruments
• Laparoscopic instruments
• Wound closure devices
• Trocars and access devices
• Electrosurgical instruments

 Application of the instrument

• Neurosurgery
• Obstetrics and gynecology
• Plastic and reconstructive surgery
• Wound closure
• Urology
• Cardiovascular
• Orthopedic
• Other surgical types

By end user

• Hospitals
• Clinics
• Ambulatory surgical centres
• Other care centres

As it can be understood from the market insights, there is a high demand for surgical instruments in India. Thus, it can be concluded that surgical instruments wholesale business in India has potential and will be profitable.

An overview of the commonly used surgical instruments

A wide array of instruments is required for varioussurgical procedures. Prior to starting surgical instruments wholesale business, it is important to have an idea of the commonly used surgical instruments. Notably, each instrument is designed and built for a specific purpose.

• Mechanical cutters, such as scalpels, lancets, rongeurs, trocars, Harmonic scalpel, etc.
• Surgical scissors
• Clamps 
• Non-locking forceps
• Needles/ Sutures
• Needle drivers/ holders
• Retractors
• Distractors
• Dilators and specula
• Suction tips and tubes for removing bodily fluids
• Irrigation and injection needles for introducing fluid
• Scopes and probes
• Cranial drills
• Dermatomes
• Measurement devices
• Bone cutters
• Sealing devices

We have only provided an overview of the surgical instruments commonly used. To get a complete list of surgical instruments and various categories for starting surgical instruments wholesale business, feel free to contact us. Additionally, we will be happy to provide consultation and guidance.

How to start a surgical instruments wholesale business in India?

For starting a surgical instruments wholesale business in India, you will need to secure a wholesale license for medical devices. This is the first and foremost requirement. Additionally, there are further requirements, such as various documents, minimum qualification and experience of the technical staff, and license use terms. In addition to medical device wholesale license, you will need to secure other licenses and registrations, such as GST, which are usually required for any business.  Thus, we have provided a detailed guide for starting a surgical instruments wholesale business in India.

License for surgical instruments wholesale business

In India, the medical device wholesale license is known as the “registration certificate”. This “registration certificate” will be mandatorily required to establish your surgical instruments wholesale business in India. An application for the medical device wholesale license (registration certificate) has to be filed under form MD-41. This application has to be filed on the CDSCO SUGAM portal. After reviewing and verifying the application, the authorities will issue the medical device wholesale license under form MD-42.

Minimum qualification and experience of technical staff required to start a surgical instruments wholesale business

For starting a surgical instruments wholesale business, you need to hire technical staff. The technical staff is expected to have the following minimum qualification and experience:

• A registered pharmacist
• A degree from a recognized University/Institution; or
• Intermediate examination pass with at least one-year of experience in dealing with medical device sale

Documents required to apply for license to start surgical instruments wholesale business

• Id proof of the applicant, such as Aadhar Card or PAN Card
• Fees receipt
• Rent agreement or sale deed of the facility
• A brief description of other activities carried out by the license applicant.
• Certificate and experience letter certifying the competence of the technical staff
• An undertaking stating proper compliance with the storage requirements for ensuring the safety of medical devices.
• Self-certification of compliance with Good Distribution Practice guidelines

Surgical instruments wholesale business license terms and conditions

1. The licensee is required to purchase the instruments only from a licensed importer or manufacturer or similar entity.
2. The licensee is required to maintain an inspection book in Form MD 43 for the regulatory officer to record observations during inspection.
3. The “registration certificate” has to be displayed at a prominent place on the premises so that it is visible to the public.
4. The sale and purchase records of all instruments have to be provided to the medical device officer during inspection.
5. All records for a period of not less than two years from the last entry have to be maintained and made available if demanded.
6. Importantly, adequate space and proper storage conditions for the storage of surgical instruments are required.
7. The requisite temperature and lighting as per the requirements of the particular instruments have to be maintained in the storage area.

What is the MD 42 registration certificate fee?

MD 42 registration certificate application fee is Rs 3000.

How to apply for the surgical instruments wholesale business license?

1. Login/Signup on the official online portal of CDSCO, the Sugam Portal.
2. Fill the online application form MD 41 on the Sugam Portal.
3. Upload all the necessary supporting documents
4. Pay MD 42 registration certificate application fee
5. Submit the application
6. The licensing authority may conduct an inspection at the premises to verify and evaluate regulatory compliance.
7. The authorities will verify all the documents and review the application.
8. Once satisfied, the state licensing authority will grant the “Registration Certificate” for medical devices under form MD 42

What is the validity of the MD 42 registration certificate for medical devices?

The MD 42 registration certificate for medical devices will remain valid indefinitely, unless suspended or cancelled by the authorities. However, a license retention fee of Rs 3000 to renew the certificate has to be paid every 5 years.

Pharmadocx Consultants team will help you easily secure the surgical instruments wholesale business license

Are you planning to start a surgical instruments wholesale business in India? Do you to need to secure the MD 42 registration certificate for medical devices? Well, you have landed in the right place. Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will help you easily secure your registration certificate.