CDSCO Requirements For Exporting Medical Equipment

Exporting medical devices from India has become a lucrative opportunity owing to the advancements made in the pharmaceutical sector. The export, import, manufacturing, distribution or sale of medical devices are administered by the CDSCO (Central Drugs Standard Control Organization). The national regulatory authority of the pharmaceutical industry operates under the ambit of the Directorate General of Health Services, the Ministry of Health and Family Welfare.

To provide a CDSCO Certificate, the authority classifies medical devices based on their intended use and other parameters. CDSCO release a class-wise list of medical devices and adds or deletes the names of such devices that require authorization from time to time.

Let’s understand in depth the requirements to export medical devices under the Medical Device Rules 2017.

What is CDSCO Registration for Medical Equipment?

Medical devices are a critical element of health care including simple items like tongue depressors and ice bags to complex devices such as cardiac pacemakers and ventilators. Indian medical device sector is Asia’s fourth-largest market that was valued at around $10 billion in 2013 and has crossed the mark of $15 billion in recent years.

In India, medical devices are regulated by CDSCO as per the Medical Rules 2017. The rules introduced the risk-based classification of devices, provision of notified bodies, and quality management system in line with ISO 13485, and made provisions to establish testing laboratories that will verify devices’ conformance with quality standards.

CDSCO register notified bodies that are legal entities responsible for conducting audits of medical device manufacturing sites. The bodies ensure that manufacturing is in accordance with the stipulated quality and other standards and eventually encourage Consumers to Prefer CDSCO-Certified Products over uncertified products. These entities audit manufacturing sites of Class A and B medical devices. The bodies are also responsible for confirming whether the sites meet the Quality management system and other applicable regulations. A notified organization is accredited by the National Accreditation Body designated by the government.

CDSCO comprise CLA (Central Licencing Authority) and SLA (State Licencing Authority). CLA enforce rules regarding the import of all classes of medical devices, and manufacturing of class C and D medical devices, and register notified bodies and laboratories to carry out evaluations or tests. The authority also conducts risk-based classification of medical devices. On the other hand, SLA regulate the manufacturing sale or distribution of Class A and B medical devices.

The CDSCO, as per the provisions of the Medical Device Rules 2017, is also authorized to conduct audits and inspections of manufacturing sites following the regulations outlined in the rules.

Apart from the Medical Device Export CDSCO Certificate, the national regulator also issues authorizations to introduce new drugs, conduct clinical trials, obtain loan licences, licence for BA/BE, and Cosmetic Licence. A CDSCO loan licence is given to a medical device manufacturer who lacks a production facility and wishes to use the manufacturing site/facility of another manufacturer.

How to Export Medical Devices from India?

The Indian medical device market is expected to grow substantially over the years. To regulate and oversee the entire ecosystem, the government revamped the regulatory framework by introducing Medical Device Rules 2017. These rules mandated the procurement of a CDSCO Certificate to export medical devices beyond the borders. To export medical devices, consider the following steps:

• Free Sale Certificate: A free sale certificate issued by the CDSCO permits the export of medical devices and IVDs (in vitro diagnostic) to global market players. Also known as ‘Certificate for Export’, the certification is mandatory for entities that export or import medical devices. FSC is a prerequisite to export devices in some nations as it indicates that the device is being freely sold and marketed in the country of origin. It serves as a mark that the device complies with legal requirements and is an assurance provided by the country sending the device to adhere to high quality and safety standards.
• Goods and Services Tax Registration: Medical devices exported from India are liable to pay a 0% GST rate. However, corporations involved in the business of export and import of any medical product or device are subjected to GST if their turnover threshold surpasses a specific threshold under the Income tax rules.
• Device Master Plan: An exporter that also manufactures the medical device is mandated to prepare a device master plan. It is a blueprint that includes specifications and information needed to produce a device from the beginning till the end. It will specify all the details regarding the manufacturing process, labelling, drawings, and packaging information. The document demonstrates that the device is safe to use and performs the intended function while meeting safety and quality standards.
• Plant Master Plan: Akin to a device master plan, a plant master plan is also a document that provides details regarding a medical device manufacturing facility. A plant Master plan assists authorities in examining and evaluating a manufacturing unit’s compliance and operational efficiency. It also helps in assessing whether the produced goods will be safe, possess high-quality traits, and be effective or not.
• ISO Certification 13485: The certification is an internationally recognized standard that acknowledges the quality management of medical devices. It sets out rules for the quality management of businesses involved in the production, installation, design, servicing, and manufacturing of medical devices. The ISO 13485 certification remains valid for three years.
• GMP Certification: Good Manufacturing Practices (GMP) certification is issued for drug formulations by the WHO and overseen by CDSCO. However, to export medical devices, the licencing authority can consider issuing the necessary certificate under MDR2017.
• Special Code/ Neutral Code: The Central Licensing authority issues a neutral code, also referred to as special code, that allows medical device producers to export their products. The code is used in place of the manufacturer’s name and address mandated to be specified on the label. It is used when a manufacturer does not wish to reflect its address or name on the packaging.

How CDSCO Certification Boosts Trust and Safety? The certification is a mark that ensures trust and operational efficiency. It serves as a validation of a business’s commitment to safety and quality standards, which enhances consumer trust and brand image in both domestic and international markets.

Key Rules Related to Export Medical Devices

To obtain a CDSCO Certificate from the concerned authorities, it is necessary to comply with the guidelines stipulated in MDR 2017. These rules are as follows:

• When a person intends to export any medical equipment and request for free sale certificate, he/she must apply to the Central Licencing Authority along with the specified fees.
• The fee as specified by the authorities to export each medical device is Rs.1000.
• Labelling requirements as per MDR 2017 include printing of some particulars on the label, shelf pack, or outer layer of the medical device. These particulars must mention the name of the device, details necessary to identify the device, name of manufacturer, date of manufacturing, net quantity in terms of weight, volume, etc. In case a medical device is being exported, the exporter must adhere to the labelling rules of the country to which the device is being exported.

What is Free Sale Certificate Rule 91 under MDR 2017?

Rule 91 of the Medical Device Rules 2017 specifies regulations regarding the export of medical devices from India. Exporters who hold free sale certificates demonstrate that their medical device is freely sold in a country and is subjected to no restriction on exporting items, validated by a responsible government authority. The certification is mandatory to export medical devices, food items, biological products, cosmetics, etc.

Countries like the European Union and the United States have made free sale certificates a mandatory document to legally sell medical devices and IVD in their markets. The certification confirms that the device is of optimal quality, safe to use, and adheres to the legal standards of the country of origin.

Why Should Consumers Prefer CDSCO-Certified Products? CDSCO-certified pharmaceuticals, cosmetics, and medical devices ensure that these products are government-approved and create no health risks. Consumers across the world can validate the authenticity, quality, safety, and efficacy of the product that comes attached to the certification. It highlights that such goods are been through rigorous surveillance and quality checks.

Final Thoughts

Exporting medical devices from/to India requires meticulous planning and adherence to guidelines specified by CDSCO. It is the national regulatory authority that oversees the pharmaceuticals and medical devices within India. To successfully export medical equipment, the exporter must be registered with CDSCO and possess a valid manufacturing licence. Their devices must align with standards set by both the authorities of the country of origin and destination regulators. Compliance with standards like FSC, GMP, and ISO 13485 remains a pivotal task to obtain the CDSCO licence and seamlessly export the goods to overseas markets.

Looking for an expert to provide end-to-end support in the entire CDSCO registration process. Connect with us to export medical devices while ensuring that you comply with stipulated regulations. Chat with the consultants of Legal Raasta who possess profound knowledge of regulatory frameworks and have provided their services to more than 15,000+ clients over the years. Obtain your CDSCO Certificate at competitive prices and with minimal hassle!