ISO 13485 Certification is required to certify the quality system of the legal manufacturing facilities as a part of the Plant Master File (PMF) application product.
The Importer Registration of medical devices under CDSCO in India is very necessary for manufacturers. To enter the Indian market, manufacturers have to fulfill the standards of quality and efficiency to import into India. In India, you are only allowed to import medical devices when you have a medical device importer license under CDSCO.
In India medical devices or products such as Cosmetics, Drugs, Medical Devices, and IVDs are regulated under the provision of the Drug & Cosmetics Act, 1940 and Rules, 1945. So, it is very necessary to obtain a medical device Importer Registration under CDSCO for the manufacturing, distribution, sale & import of commodities. After the registration under CDSCO, you can simply import medical devices into India.
The full form of CDSCO is the Central Drugs Standard Control Organisation. CDSCO is a national authority that is responsible for the approval and regulation of pharmaceuticals, medical devices, and cosmetics in India. The aim of the CDSCO is to confirm that the medical products available in the market are healthy & safe to use for consumers from the side of manufacturer, sale, distributor, or importer. For approval, you have to apply under the CDSCO registration for Importer Registration of medical devices.
CDSCO makes all the efforts to ensure that the only safe & effective medical devices enter the market. The list of medical device approvals is very large it includes everything from diagnostic equipment and surgical instruments to medical software.
Importer Registration for medical devices is necessary for all those who are interested in regulating Medical products in the market. The significance of Importer Registration of medical devices are:-
The medical devices in India are classified into two categories for better understanding during the time of MDR for importers.
When you go for the registration you will find the various classes of medical devices. Each category of medical device have risk and here you will get to know about the classification of risk of Indian medical device for Importer Registration:-
| Device Classes | Risk |
| Class A | Low Risk |
| Class B | Low Moderate Risk |
| Class C | Average Risk |
| Class D | High Risk |
In the Importer Registration of medical devices few regulatory bodies are accountable are as follows:-
Under the CDSCO act authorized Indian agents can apply for the import license. The manufacturer can apply for it for sale & distribution but must have manufacturer license. The wholesaler can apply for the sale & distribution of importer licenses of medical devices under CDSCO. The agents just have a file an application to get a medical device import license.
To apply for the Importer Registration of medical devices under CDSCO you have to follow the basic steps. Simply follow these steps and apply for it now:-
Step 1 – The person who wants to import medical devices or in vitro devices into India from any foreign nation, shall apply for an importer license to the central licensing Authority by Form MD –14 for all risk-category medical devices.
Step 2 – The fee must be paid with the application form to the CDSCO medical devices registration import license fee. It is paid with the premises or unit where the manufacturer aims to import the medical devices.
Step 3 – On receipt of the application, the central licensing Authority shall determine the quantity of the medical devices, after taking into account the requirement for clinical investigation, approve the clinical investigation plan and information, and check all documents submitted by an applicant.
Step 4 – After such inquiry, if the central licensing Authority is satisfied then issue a grant of import licence in MD-15. In case if central licensing Authority rejects the application, and raises the query then the applicant needs to reply to the queries by providing appropriate documents according to the guidelines under CDSCO.
When you fill out the form it requires the following information that is necessary to get a medical device FDA importer license in India under CDSCO.
For the Importer Registration of medical devices following documents are required:-
The FDA importer medical device license is valid permanently just you have to pay a fee of it every 5 years. If you do not pay the fee then the license will be suspended or canceled by the Central Licensing Authority (CLA).
As per the Final notification by CDSCO, if one wants to import a medical device that is class A nonsterile and non-measuring now no longer needs a registration under MD-15.
They can proceed with a voluntary registration number which can be obtained with the help of the ELT Corporate Medilaw Team.
Any individual, business, or other organization, that has obtained valid importer registration for the medical devices to be imported is allowed.
In such cases, the higher class of medical devices will be considered
The list of authorized notified bodies under (CDSCO) is available on the CDSCo website. To receive the latest copy of the notified bodies, click here (Name, M.No., Email, Message) Please send me the Latest notified bodies list.
The notified body under CDSCO shall be competent to carry out an audit of the manufacturing site to ensure the conformity of the prescribed standards of the Quality Management System (QMS) and other applicable tender advised by the state licensing authority(SLA).
According to the Medical Device Rule 2017, the National Board for certification bodies (NABCB) shall lay down the conformity assessment activities for the accreditation of Notified bodies prior to registration with CDSCO.
Devices such as sedentary pads, Tampons Etc. were removed from the list because the government does not want people to have compliance difficulties on routine items.
For the application for an import or manufacturing license, applicants group all medical devices in accordance with government guidelines. In case of differences in intended use, product specification, and principle technology of the medical devices, separate fees need to be submitted.
PMS is the responsibility of a licensed holder or authorized agent.
Import licenses are valid for five years and are renewed through a simple administrative process.
ISO 13485 Certification is required to certify the quality system of the legal manufacturing facilities as a part of the Plant Master File (PMF) application product.