India has gained a reputation for manufacturing high-quality medical devices at competitive prices. The country has supportive regulatory requirements, skilled workforce, and cheap labour offering cost advantages. This has made India a potential global hub for manufacturing medical devices. Thus, exporting these devices have become a lucrative option. Indian medical device industry manufactures various products ranging from surgical instruments and implants to diagnostic equipment and hospital furniture. Medical device manufactures are leveraging the potential of the medical device export industry. The Indian medical device export industry has various internal and external regulations to which the manufacturers have to abide by. One of the requirements is neutral code for medical device exporters.

This code is required when overseas buyers require the manufacturers to not reveal their details. The medical device manufacturers cannot mention their name or address on the product label. Hence, the neutral code for medical device exporters is used. This blog sheds light on the neutral code for medical devices.

Exporting medical devices

Every medical device manufacturing company focusses on regulatory compliance, patient safety, and customer satisfaction. The manufacturers aim to deliver the best medical devices to the healthcare industry in order to maintain their name and reputation. As business goes global and distribution increases, quality and compliance are strictly enforced by regulatory bodies. Exporting medical devices requires compliance with Indian as well as international regulatory requirements. The process of exporting medical devices from India requires adhering to quality benchmark and abiding by local and international laws. Thus, a thorough knowledge of essential regulations and best practices of the Indian medical device export process is required.

The medical device exporter needs to be registered with the Central Drugs Standard Control Organization (CDSCO). The exporter also needs to have a valid manufacturing license. An effective and efficient quality management system (QMS) is required to comply with the requirements for exporting medical devices. Owing to certain external regulatory requirements, manufacturers are required not to disclose their own name or address on the product. Instead, a special code or neutral code needs to be placed on the product label. The term neutral code or special code is usually used interchangeably. A manufacturer seeking a neutral code or special code for medical devices needs to apply to the CDSCO. CDSCO is the national regulatory body overseeing medical devices sold in India. It is also the licensing authority for neutral code or special code. Additionally, CDSCO issues the no objection certificate (NOC) required for exporting medical devices.

Basic regulatory requirements for exporting medical devices

To export medical devices, certain regulatory requirements have to be met and adhered to. The following are the basic regulatory requirements that medical device exporters have to comply with:

• Classification of the medical device based on its risk level and intended use.
• Quality management system developed according to the internal and external standards and regulatory requirements.
• CDSCO registration and valid medical device manufacturing license.
• The medical device quality must abide by Indian and international criteria and standards.
• Proper packaging and labelling with device name, intended use, and batch details clearly stated.
• Clinical data and safety and performance information may be required.
• Proper documentation, including invoices, packing lists, and shipping details, must be recorded and presented for export of the medical device.
• Adverse event reports need to be properly documented.

The aforementioned list presents generalised requirements. In addition to the above, there may be additional and specific requirements for exporting medical devices.

What is the neutral code for medical device export?

The neutral code is issued to permit the manufacturing of medical devices for export purposes. The neutral code for medical device is granted to licensed manufacturers of medical devices. Neutral code enables medical device manufacturers to export their medical devices without disclosing their name and address on product labels. This may be a requirement of external laws. Additionally, the overseas buyer may not want to reveal the identity of the manufacturer to the target customers. Hence, the buyer may request the manufacturer to mask the manufacturer’s details on the medical device. This may be done by replacing the details with the neutral code. The manufacturer must file an application with the regulatory body to obtain the neutral code for medical device export. Several supporting documents are required for applying for the neutral code. After the application is approved, the neutral code for medical device export is granted. Then, the manufacturer can export the medical device by printing the product label with the neutral code in place of the manufacturer details.

Documents for neutral code application

Multiple supporting documents are required for the neutral or special code application process. CDSCO has provided a detailed checklist for all the documents required for the application to obtain the neutral code. Listed below is an overview of the documents necessary for the neutral code application for medical device export:

• Application for export no objection certificate on duly signed company’s letter head
• Valid export order on the overseas buyer’s letter head detailing the quantity and name of the product to be exported
• A letter from the overseas buyer on their letter head mentioning the need for special code or neutral code number
• A copy of the manufacturing license
• A copy of product permission for specific product or no objection certificate for export for specific product prototype packing material, including cartons, leaflets, labels, etc. mentioning the specific or neutral code

The medical devices portal at https://cdscomdonline.gov.in provides the detailed list of documents for neutral code application.

Simplification of the application process for the neutral code for export of medical devices

In an attempt to simplify the neutral code application process, CDSCO has transformed the procedure for obtaining the neutral code for export of medical devices. Recently, the CDSCO has issued a notice regarding the online neutral code application process. A new online application portal has been developed to streamline and simplify the process. This digital platform will eliminate the need for paperwork and expedite the process. This step will significantly enhance the regulatory procedure for obtaining the neutral code for manufacturing medical devices with the intent of exporting them. All healthcare stakeholders have been mandatorily urged to adhere to the new online application portal and process.

As per the guidelines mentioned in the Medical Devices Rules, 2017, the neutral code will be issued by the Central Licensing Authority. The Online System of Medical Devices portal is available at https://cdscomdonline.gov.in. A checklist has also been provided on the online application portal. All applicants must refer to this checklist to apply for the neutral code for medical device exporters. Medical device manufacturers seeking the neutral code have been requested to use the online submission process only via the specified portal.

Manufacturing medical devices for export purposes

India has garnered a considerable reputation as the manufacturing hub for high-quality medical devices. Hence, manufacturers are utilizing this reputation to establish a medical device export business. The neutral code for medical device is one of the essential documents required for exporting medical devices. Assistance with CDSCO medical device regulatory requirements is one of the Pharmadocx Consultants team’s forte. Pharmadocx Consultants can help simplify all your medical device manufacturing and regulatory needs. Call/Whatsapp us at 9996859227 or drop an email at [email protected].