How to import surgical instruments from Pakistan to the USA? Establish a surgical instrument busines
We are often approached by our website visitors from the US who are looking for information on how to set up a surgical instrument company within the United States, while sourcing surgical instruments from the lucrative market of Pakistan. While many visitors have doubts about the FDA approval of Pakistan-made instruments, others are unaware about the basics of setting up a business in United States. Since this information is requested too frequently, we decided to publish this information on our website to facilitate everyone who is willing to benefit from import of Pakistan-made surgical instruments.
Setting Up a Business within US
Getting a Business license
Individuals willing to set up a surgical instruments business within the US need to apply for a business license to sell surgical instruments. For this purpose you need to visit the County office or City hall in your area. You may visit their relevant website for this purpose and then act according to the information provided there.
For example, if you are willing to establish your business in Chicago, you can visit here, to get your desired information; in some cases you may even apply online. People residing in other states may search for information (online) that is relevant to their own states.
Registering for Tax Identification Number
Your need to get your Tax Identification Number to pay all your taxes.
Click here to get information about your taxes within the US.
To download tax related forms, click here.
Alternatively you may Call (800) 829-1040 to get your required information.
Sourcing Surgical Instruments from Pakistan
One of the main concerns about importing surgical instruments from Pakistan is whether these instruments are approved by FDA for sale in the US or not. Some insight into the history seems appropriate at this point. In 1991, FDA issued an import alert (termed “Import Alert 76-01”), which related to the import of stainless steel surgical instruments from Pakistan. This import alert was suggestive of the fact that the instruments exported from Pakistan were violating section 501(c) of the Act, because the quality of exported instruments was inferior to what was being claimed. Documented analysis revealed that the Chromium content in Pakistan-made surgical instruments was “ variable ”.
In reality, if FDA issues an import alert, it should be considered a warning for the importers, and they should exercise caution regarding import of products which are included in an import alert. FDA uses a term called Detention Without Physical Examination (DWPE), which means that the FDA has the power to detain such products at the border. Read More
To overcome this issue and to facilitate foreign manufacturers, the FDA implemented a third party Quality System Audit Program coupled with sample analysis regimen. The purpose of this approach was to provide exemption to Pakistan-based firms that were producing surgical instruments of good quality i.e. acceptable for use within the United States. Based on this approach, a “Green-List” is published, which lists the Pakistan-based firms and their products that have met the criteria for " exclusion " from Detention Without Physical Examination (DWPE).
Click here to access the Green List (Published 31st Jan ‘2018).
Establishing your business Model
So, now you have the “Green-List” of Pakistan-based manufacturers and you want to proceed further. Speaking in broader terms, you can opt to:
1) Establish your own BRAND; since many Pakistan-based manufacturers offer OEM services.
2) Simply import surgical instruments to the United States and sell them.
This is entirely your own decision and you need to do your own research to decide what suits you the most.
Doing Research in your Local Area
You need to be aware of the demand of surgical instruments in your local region. A prominent strength of Pakistan-based surgical instrument manufacturers is their ability to produce high-quality “ disposable-type ” instruments. Hence, you can visit your local hospitals, clinics, medical universities, government medical facilities, dentists, surgery centers and nursing homes etc, to understand the local demand of disposable-type surgical instruments and to develop your contacts for generating sales, later on. Additionally, you can read books on related topics and subscribe to online Newsletters & Magazines to stay updated in this regard.
Know your selected products
If you are new to surgical instruments, you may be overwhelmed by the immense variety of surgical instruments that are in use by the surgeons' community. You need to learn about the products that you are planning to import and market. Different resources may be used for this purpose. A simple tool that we recommend to learn the basics is an app on the Google Play Store i.e. “General Surgery Instruments” by K.S.M Studio. There are many others; you are free to choose.
The Import Process
Unlike most other countries, a license is not required to import into the United States, unless you are importing products that fall under classes such as firearms or human body parts etc. However, importers should bear in mind that the sale of medical devices including surgical instruments is regulated by FDA’s Center for Devices and Radiological Health (CDRH). Hence medical devices are classified into Classes I, II & III. The level of regulatory control increases from Class I to Class III, as described below:
Class I Medical Devices: [ These devices may enter the US by assuring that medical device labeling complies with prevailing regulations of FDA + These devices are not meant to prolong or support life + Exempt from Premarket Notification 510(k) ]
Class II Medical Devices = [ These medical devices carry greater risk to health if they are faulty + May require Postmarketing surveillance (PMS) + Require Premarket Notification 510(k) ]
Class III Medical Devices = [ There is lack of information about the safety of these devices + Usually such devices support or prolong life + Require premarket Approval ]
Most Handheld surgical instruments fall under Class I, and are therefore exempt from Premarket Notification 510(k). However, it is always a good idea to check the classification of your desired instruments before making your decision to import.
You can check the classification of your desired medical/surgical device/instrument here.
To read more about device regulation, click here.
To read more about Importing into the USA, Click here.
An alternative approach to sourcing surgical instruments from Pakistan could be to look for a Pakistan-based surgical instrument manufacturer who already has " business-presence " within the United States. In this scenario, the burden of handling the import process will be on the shoulders of manufacturer and you can simply source your desired instruments from that manufacturer (within the US) and sell in your state/local market. However, this approach may diminish your profits.
Before you proceed to initiate the distribution process, you should be aware of the fact that the Congress has authorised FDA to collect an annual " Establishment Registration fee ". Those involved in the distribution of medical devices for use in the United States have to register with the FDA annually (Establishment Registration - Title 21 CFR Part 807). You can check the schedule of annual registration fee here, (which for the fiscal year 2018 was $4624; in 2019 it is $4884 only).
You can use this LINK to check whether you require 'establishment registration' or not.
In essence, this is the first thing that you should consider before even thinking about importing surgical instruments for sale in the US. In the modern world where competition is fierce, you should have a very good understanding of your own ability to promote and sell a product in the market of your choice.
If you are good at convincing people and if you have the desired medical knowledge, financial strength and social resources that may assist you in generating sales – this business is ideal for you, even if you operate it from the comfort of your home.
We wish you success in your future business endeavors!
For queries, feel free to contact us.
Disclaimer: Medeveryday bears no responsibility of any possible loss that may ensue due to the use/misuse of this information. This content is for information purpose only. Although this information is well-researched at the time of publication, minor inaccuracies are always possible, and information may become outdated with the passage of time. Readers should use their own judgement and resources when making business decisions.