Central Drugs Standard Control Organization (CDCSO) is the highest Indian regulatory body that monitors the production of authorised medical devices. CDSCO is in charge of issuing licences and approving the manufacturing of medical devices. This problem of regulatory body Medical Device Manufacturing License by the Medical Device Rules of 2017.
While manufacturing medical devices, a manufacturer must follow strict procedures following the regulations and standards the Central Drug Standard Control Organization (CDSCO) set forth. The New Medical Device Rules are enforced mainly and administered by the Central Government and the State Government. CDSCO works in coordination with the State Government to ensure uniform rule enforcement.
Medical Device Regulation in India – An Overview
If a manufacturer wants to obtain Medical Device Manufacturing License for any class of medical device, there are a series of steps followed for the same. The applicant must apply for Manufacturing License to sell or distribute medical devices. The applicants must use the online portal of the Ministry of Health and Family Welfare to apply for consent from the State Licensing Authority based on their location. Forms MD-3 and MD-5 are used to obtain a licence for Class A and Class B medical devices. For the application, the manufacturer must submit an application in Form MD-3 and the necessary paperwork in Form MD-5. While Form MD-7 and MD-9 are used to obtain the licence to manufacture Class C and Class D medical devices, Form MD-7 is used to apply for permission to manufacture Class C and Class D medical devices for sale and distribution, and Form MD-9 is the license for the same.
Authorities Regulating CDSCO Registration
The following bodies regulate all the rules related to medical devices in India:
- Central Drug Standard Control Organization-
CDSCO is the highest regulatory authority for drugs, IVDs and medical devices, governed by the Directorate General of Health Services under the Ministry of Health & Family Welfare. It is also called CLA or the Central Licensing Authority of India. The CLA is responsible for providing a Medical Device Manufacturing License for class C and Class D medical devices with the high risk involved. It is responsible for regulating the import, sale and manufacturing of medical device Class C and Class D. It is also responsible for regulating rules and procedures for IVDs. It also approves new medical devices and tests their clinical performance and quality standards. It also grants registration of labs for performing the tests and regular evaluation. It also gives licenses for manufacturing or importing all classes of IVDs.
- Drug Controller General of India (DCGI)
The head of CDSCO regulates clinical trials and approves the quality and standards of drugs, medical devices and cosmetics for selling, importing or manufacturing in India.
- The Drugs and Cosmetic Act and Rules
The procedure of manufacture, import, and distribution are governed by the Drugs & Cosmetic Act and Rules.
- State Licensing Authority
The SLA or State Licensing Authority is the regulatory body responsible for providing Medical Device Manufacturing License to medical devices with low to medium risk levels. It gives licenses to Class A and Class B medical devices in India. The State Licensing Authority is authorised to grant licenses for manufacturing, loans and wholesale of Class A & Class B Medical Devices. SLA authorises a Notified Body to inspect the Quality Management System and Technical Review for Class A & B Medical Device manufacturers. It makes and regulates the rules and regulations for manufacturing, importing and selling of Medical Devices.
Medical Device Classification Based on Risk Levels
As per the New Medical Rules of 2017, medical devices have been divided into four classes. Class-A, Class-B, Class-C and Class-D medical devices. Any manufacturer that intends to produce such devices for distribution or sale must apply for a manufacturer’s licence from CDSCO. There are four classes of Indian medical devices listed below-
- Class A – the low risk involved
- Class B – low to the moderate risk involved
- Class C – moderate to high risk involved
- Class D – the high risk involved
Medical devices classified as Class A and B are considered low- and moderate-risk, respectively. The applicant must apply to manufacture these classes of medical devices to the State Licensing Authority. Classes C and D Devices are categorised as High Risk and Extremely High Risk, respectively. The Central Licensing Authority must receive the application for their production.
Forms required to obtain Medical Device Manufacturing License
The Manufacturing License for the sale and distribution of Class A and Class B medical devices is subject to regulation by the State Licensing Authority. To obtain a licence, the forms MD-3 and MD-5 are used; the applicant must submit an application in Form MD-3 along with the necessary paperwork, and the license is obtained in Form MD-5.
To get a Manufacturing License for class C and Class D medical devices, The manufacturer must submit an online application using Form MD-7 through the Central Licensing Authority of the Ministry of Health & Family Welfare in the Central Government to be granted a Medical Device Manufacturing License for the continued sale & distribution of Class C and Class D medical devices through Form MD-9.
Documents required to obtain Medical Device Manufacturing License
- Application Form
- ISO 13485 Certificate
- TR6 Challan
- Power of attorney
- Undertaking that only authentic details are provided
- Full quality assurance certificate
- CE Design certificate
- Declaration of conformity
- Schedule D(I)
- Device master file
- Plant master report
- Free Sale Certificate
Procedure to Obtain Medical Device Manufacturing License
Before 2006, there were no laws or regulations governing the sale or use of medical devices in India. Later, CDSCO issued a rule requiring all medical devices sold on the market to comply with CDSCO. Medical Devices must be registered with CDSCO before being manufactured, sold, or imported into the Indian market due to compliance requirements. The steps to obtain Medical Device Manufacturing License in India are listed below. –
- Check whether a Medical Device Manufacturing license is required or not-
The person applying for the license must first check if the medical device has been notified. All medical devices that have been reported are required to be registered before being marketed in India.
- Classification of Medical Devices based on risk-
As per the risks associated with each device, the notified ones that must be registered with CDSCO are then determined.
- Appointment of Indian Authorized Agent-
If the manufacturer is not an Indian, an IAA/Indian Authorized Agent, has been named. The IAA, the manufacturer’s official representative in court, carries out all of its business in India.
- Documentation Procedure-
To obtain a Medical Device Manufacturing License, all required paperwork must be submitted to the appropriate authorities.
- Receiving Registration and License-
After submitting all required documents to the appropriate authorities, the manufacturer receives the Medical Device Manufacturing License.
Timeline for Medical Device Manufacturing License
The validity of the Manufacturing License is five years. In the case of the request being suspended or cancelled, the applicant shall apply within 45 days from the date of the action.
The Indian medical regulation and rules have become more complex over time. There was no such authority to regulate Drugs, Medical Devices and other medicine-related products in India. Still, now the CDSCO performs all the tasks to regulate and control such activities. There are multiple categories of devices that require registration in India. Medical Device Registration is a complex process and requires only regulated devices to apply for registration. For all the devices that do not require any registration, a NOC has to be obtained from the DCGI to sell or market those products. The NOC letter signed by the DCGI signifies that there is no requirement for product registration, and it can easily be marketed in India just by carrying the NOC.
Read our Article:CDSCO Medical Devices Manufacturing Registration Requirement