Import Medical Instrument USA
Every country adopts a well-defined procedure to Import Medical Instrument USA & from various other countries. Apart from the regulations of the importing nation, the USA has a protocol to adopt while exporting such medical instruments out of their country. Let us first revisit what their standards are:
- The medical instruments made in the USA can be exported to various other countries with a certification from the Food and Drug Administration (FDA). The certification is a mandate that every company in the USA needs to adopt while making or manufacturing the medical devices.
- Importers should note that all medical devices that are legally marketed in the USA can be exported without prior FDA approval
If such devices that are not cleared in the USA are to be exported, then they must comply with the provisions mentioned in Federal Food, Drug and Cosmetic (FD&C) Act
- Depending on the specific section of the FD&C Act that a firm is exporting under, every firm must send/ submit a simple notification indicating the export
- Alternatively, the firm can also request for an export permit letter or export certificate
- These certificates serve as a proof of the product’s authenticity and compliance for export by other nations
- Foreign Government Certificate is the most commonly requested export certificate and additionally, a Certificate of Exportability could also be requested for devices that are for research purposes and are for nonclinical usage
- The USA facilitates the export certificates Requisition through an Export Certification and Tracking system – an electronic means where other nations witness lesser certificate processing time, cost savings on paper applications reduction and regular status updates to the request raised
- Firms can register themselves on the FDA Unified Registration and Listing Systems (FURLS) and process all certificate requisitions using the registered information
After assessing the key export criteria from the USA for medical devices, let us assess what a nation like India needs to do to import the devices into the country.
The first step in the process is getting the import license granted-
- All imports of medical devices should comply with the process that is detailed for registration and the import license under the Drugs and Cosmetics Rules
- An approval of the competent authority is required to process the import of the medical devices into the country (specifically in the case where no earlier imports are observed)
- Registration of the medical devices for the import is done in close conjunction with the manufacturer from the USA with the importer in India
- Applicants for import need to pay an upfront registration fee of 1500 USD for the premises to which the medical devices will be imported to. Every device is to be registered with a fee of 1000 USD (variants of a device can be registered under a single device entry)
- Applicant’s details, product/ brand information and the regulatory status of the devices (specifically the FDA clearance/approval) have to be furnished to the concerned authorities for the registration to be completed
- Quality Assurance procedures that are followed by the manufacturer in the USA need to be detailed to the board of authority for verifying the quality standards of the product
- With post marketing surveillance information and related assessment regarding the medicinal products on the devices, an import license may be granted to the importer for importing the medical devices into the country
The import process
The USA exporter provides the pro forma invoice that has the information regarding the price of the goods to be shipped (the prices include insurance and freight charges). The Indian importer places the order for the import once the agreement on payment terms arrives. The importer has to track the shipment (either through air or ship) and also take care of clearance at the customs.
A bill of entry is to be submitted while the clearance is in progress at the customs and along with the same, several other key documentation pertaining the export/ import procedures are to be produced. Some key documents are:
- Signed invoice
- Import License
- Bill of Lading or Airway Bill
- Insurance documentation
- Certificate of Origin
Once the customs verify the goods for its correctness of the description mentioned in the consignments or that is stated on the bill of entry, the importer clears all the duty payments and seeks the delivery of the medical goods.