All the regulations related to medical devices in India for their import, sale, distribution, stocking, and manufacture are regulated by the Central Drug Standard Control Organization (CDSCO), which is the national regulatory authority in India. Medical devices are crucial devices used in different types of medical emergencies and directly impact citizens’ health; hence, high-level verification and inspection need to be done before they are introduced in the market for import, sale, manufacturing, or distribution.
The other aspects, such as packaging and labeling of medical devices, are also essential and are to be regulated by the authorities responsible for them so that the devices do not share any misleading information.
What is a Class 1 Medical Device?
Medical equipment categorized into class 1 is almost risk-free. Up to this point, the manufacturer of Class 1 medical equipment informs the organization to inspect the location after first reviving the issued license. The manufacturer can expedite the procedure and reduce the burden on notified bodies by self-certifying the medical equipment after it falls under a Class 1 non-sterile non-measuring device.
Stepwise Guide to Register for Class 1 Medical Devices
All the medical devices are to be registered with the regulatory authorities in India. Following are the steps that can be followed for registering for class 1 medical devices:
- Before the registration process starts for a medical device, the first step is to find its classification according to the medical devices that are notified.
- Check whether the device falls under the class 1 notified medical devices or not in India.
- Fill out the forms that are necessary for class 1.
- If the medical devices are to be sold or distributed, provide the authorized agent’s details and fill out the appropriate forms.
- Submit all the documents that are required during the registration procedure.
- The authorities will inspect the manufacturing site and the devices.
- If all the information provided is accurate and the inspection is also approved, then the registration takes place.
Legal Framework for Medical Device Registration
The three key legal frameworks for medical device registration are:
- Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945
This act provides rules and regulations related to the sale, manufacture, import, and distribution of drugs in the country.
- Medical Devices Rules, 2017
These rules mention the rules relating to medical devices and their distribution, sale, manufacture, and import.
- Medical Devices (Amendment) Rules, 2020
The Medical Devices Rules were amended in 2020. These rules consist of amended rules for distribution, sale, manufacture, and import.
Vital Forms for Class 1 Medical Device Registration
There are some essential forms that are to be filled out at the time of class 1 medical device registration in India. Filling and submitting all the forms are crucial for having a smooth registration without any obstacles. The essential forms for Class 1 medical devices are:
- Form MD – 3
Any business that wants to start manufacturing class-notified medical devices has to fill out this application form.
- Form MD – 4
When the business is looking for a loan license, Form MD – 4 is to be filled out for application.
- Form MD – 5
Manufacturing permission must be applied for to use this Form MD—5 for a class 1 notified medical device. The fee for a single site is Rs. 5000, and for a medical device, it is Rs. 500.
- Form MD – 6
The loan license permission is to be applied with this form.
- Form MD – 14
This form is to be filled out when class 1 is notified that medical devices are to be imported.
- Form MD – 15
The form for which permission to import the medical devices of class 1 is MD – 15.
Documents Required for Class 1 Medical Device Registration
Whenever it comes to any time of the registration process, a document is an essential part of the registration process. Some of the documents that are required at the time of Class 1 medical devices are:
- Authorized Agent or Manufacturing Firm’s details of the constitution
- Lease Agreement/Property Agreement
- Cover Letter
- Quality Certificate, which is notarized in relation to the manufacturing site (copies)
- Quality management system certificate (copy)
- Fees
- Master file of the plant
- Master file of the device
- License of testing
- Proof (Undertaking) that the site of manufacture complies with a quality management framework
- All vital forms that are required for registration
Advantages of Class 1 Medical Device Registration
There are many advantages of class 1 medical device registration in India. Let’s take a look at some of the advantages of Class 1 medical device registration.
- Compliance
Having a class 1 medical device registration ensures that the business is following all the legal standards and rules laid down by the regulatory authorities in India. Compliance with all standards shows the business’s dedication to regulation and compliance.
- Business Credibility
When a business follows all the rules and regulations and all annual regulatory compliance, it shows its commitment to rules and regulations. The business’s image in the market becomes positive, and credibility and goodwill are built.
- New Market Access
Businesses that have products that comply with all national rules are seen as positive signs when entering a new market. The new consumer base will observe that the business is already in full compliance and has a good track record. This will help the business enter the new market smoothly on a global level as well.
- Customer Safety
Consumers are attracted to products that have good reviews and are safe to use, especially medical devices. When a business’s products are proven to be safe, consumers buy them more easily. When class 1 medical devices are registered, it shows that all the necessary tests have taken place at the time of the registration process by the authorities, and the regulatory authorities give them a green flag.
Conclusion
To sum up, it is vital to register your medical devices before they can be distributed, manufactured, or imported. The medical devices are classified into four classifications in India – Class A, B, C, and D. The classification of the medical devices is based on the risks and their uses. As discussed in our blog, class 1, medical devices are very low in risk. For registering the medical device, a proper registration procedure is to be followed by the business. Corpbiz can help you with your Class 1 medical device registration in India. Our experts have extensive knowledge in the field and can provide our clients assistance and guidance in the entire journey of class 1 medical device registration.
Frequently Asked Questions
Is there regulation of medical devices in India?
Yes, the Drugs & Cosmetic Act 1940 & Rules 1945 control the importation, manufacturing, marketing, and distribution of medical devices in India.
Which CDSCO (HQ) division is in charge of medical device importation and licensing in India?
The Ministry of Health & Family Welfare's Medical Device & Diagnostics Division, the Central Drugs Standard Control Organization (CDSCO), & the Directorate General of Health Services are in charge.
Are Class 1 devices low in risk?
Yes, class 1 devices contain the medical devices that are low in risk.
How long does registering a class 1 medical device in India take?
The time may differ from application to application for the registration of class 1 medical device.
Is an inspection of the medical devices at the time of the registration process vital?
Yes, as medical devices are vital devices, after the registration application is submitted, an inspection is carried out to ensure that the manufacturing site and a report for the same are submitted to the authority responsible.
What are the essential forms required for class 1 medical device registration?
The significant forms for the class 1 medical device registration are Form MD – 3, Form MD – 4, Form MD – 5, Form MD – 6, Form MD – 14, and Form MD – 15.
Why is class 1 medical device registration necessary?
It is essential to register class 1 medical devices before any business for them is initiated. Whenever anyone wants to import, manufacture, or distribute a medical device, they have to register it first.
Read also about A Guide On CDSCO Guidelines For Medical Devices In India
