Medical Device Registration process in Indiabefore manufacturers of certain medical devices can sell within India they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. Previously, the medical devices manufacturers were free to sell their products in the Indian market without any regulation. Since 2006, the medical devices imported from overseas locations need to comply with Indian medical device regulations established by CDSCO.
The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. For an overview of the regulatory process, see or download the approval chart below. TheMedical Device Registration process in Indiahas become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.
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Classes of Medical Devices
The medical devices in India have been categorized into four classes based on the criticality and risk they offer to the patients.
- Class A:Represent the low-risk category of the products such as thermometers, and tongue depressors.
- Class B:Represent moderate-risk products such as suction equipment and hypodermic needles.
- 丙级:Represent moderate-high risk products such as bone fixation and lung ventilator.
- Class D:Represent high-risk products such as implantable devices and heart valve.
TheMedical Device Registration process in Indiacannot be granted to someone who not from the Indian Territory. The said act allows the overseas manufacturers to hire an authorized Indian agent to address the registration formalities. The manufacturer needs to ensure that the hired professional should be registered under CDSCO. Plus, he/she should possess a whole drug license as well in the form of 20B and 21B.
This is the first and foremost step in theMedical Device Registration process in India. Here, the hired agent needs to prepare and submit a dossier against the requested list of documents. The following list demonstrates the type of documents required for registration purposes.
- Form 40
- TR6 Challan
- Schedule D(I)
- Power of attorney
- Quality assurance certificate
- Conformity declaration
- 项目经理报告
- Master file of the device
- Master file of the plant
- Sale certificate
- Regulatory approvals
- CE certificate
Medical Device Registration process in India
The registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review.
Devices registered during the voluntary registration period benefit from a truncated application that involves administrative documents such as Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information.The voluntary registration process carries no government processing fees but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License.
The Medical Device Registration process in India is crucial for distribution purposes. The concerned authority would penalize any manufacturer who wishes to sell the product in unregistered condition.`