The Central Drugs Standard Control Organisation (CDSCO) operates under the Directorate General of Health Services, the Ministry of Health & Family Welfare, under the Indian government. It is the National Regulatory Authority (NRA) of India. The Drugs and Cosmetics Act of 1940[1] now requires the registration of all medical devices as of April 1, 2020, in addition to the 23 previously notified medical devices. Starting October 1, 2022, all medical devices in Classes A and B will need Import Licenses before they can be brought into the country. By October 1, 2023, all Class C and D devices that have not already been notified will be required to obtain Import Licenses. Medical devices that don’t need Import Licenses yet should still register their product through an e Portal, which can be done in a couple of days. The procedure of obtaining an Import license can be done by filling Form MD-14 and MD-15.
Under the Drugs & Cosmetics Act, the CDSCO is in charge of approving new drugs, running clinical trials, setting standards for drugs, keeping an eye on the quality of drugs that are brought into the country, and coordinating the actions of State Drug Control Organizations by giving them expert advice. The goal is to make sure that the Drugs and Cosmetics Act is enforced in the same way everywhere.
Requirement for Registration and Import License for Medical Device
All medical devices must either be registered or require an Import License. Device Master Files (DMF) for each product and Plant Master Files (PMF) for each manufacturing facility must be submitted in order to apply for an import licence for the Notified device categories. Once they are accepted, medical devices will be required to register under an Import License tied to the main place where they are made By October 1, 2022, all Class A & B medical devices will require an Import License in order to stay on the market. The last Class C and D devices that haven’t been notified will be given time until October 1, 2023 to obtain an Import License. In the meantime, they will have to register as a Non-Regulatory Product.
Form MD-14 and MD-15: Meaning
The CDSCO (entral Drugs Standard Control Organization) has made a set of forms that people can use to apply for licences to use medical devices. These forms are different depending on what they will be used for. According to the risk associated with various medical devices, various forms have been categorised for importers and manufacturers. It’s easy to apply for a single medical device, but it takes a lot to apply for the import or production of multiple devices. There are 2 forms which need to be filled to get a license for Medical Devices- Form MD-14 and MD-15.
Form MD-14: Form MD-14 is filled to get the permission to import medical devices license based on Class A, B, C or D. Fill out Form MD-14 to get a licence to import medical devices from Class A, B, C, or D.
Form MD-15: is a licence from CDSCO that lets people bring medical devices into India based on their A, B, C, or D classifications.
Eligibility Criteria for Import License for Medical Devices
It is necessary to appoint an authorised Indian agent in order to obtain a licence using the Form MD-14 and MD-15. According to CDSCO rules, this agent must have a licence to manufacture or wholesale License Form 20B & Form 21 B. The agent will submit a request using Form MD-14 and MD-15 to obtain a licence to import medical devices.
Procedure for Obtaining Import License for Medical Devices
According to the Medical Device Rule of 2017, the procedure for obtaining “Permission to Import Medical Devices” from CDSCO is as follows:
- Product evaluation to determine whether it requires MDR 2017 registration (Regulated/Non-Regulated).
- If registration is required, evaluate classification (Class A, B, C, and D) based on the product risk category.
- Make documents according to the MD 14 checklist
- Choose an authorised agent
- Online creation of applications
- Approval/confirmation of draft application by the authorised agent.
- Submission of application
- Follow up with the regulatory authority and query management; if any
- Medical device import approval in India is permitted
Validity of Licence
Form MD-14 and MD-15 are used to get a licence to import medical devices. These forms are valid for life, or forever, as long as the licence retention fee is paid on a regular basis, as mentioned in the Second Schedule. The licence retention must be paid each time before the 5-year mark from the date the licence was issued unless the Central Licensing Authority suspends or cancels the licence.
Authorized agent or Registration holder for Medical device
In order to sell medical devices in India, a foreign manufacturer must first obtain the appropriate registration as required by Indian law. A foreign manufacturer is required by law to designate an authorised agent/registration holder to handle the formalities on their behalf for services involving medical devices and equipment.
A company that lacks a local presence or registered office in India is required to hire an authorised agent to act as an intermediary in order to manage registration. Also, the agent is needed for post-market surveillance of medical devices and equipment. The authorised agent acts as a go-between for the foreign manufacturer and the licencing authority, presenting any data, documents, facts, or information on behalf of the company.
Permission to Import License Form MD-14 and MD-15
Form MD-14 must be filled out in order to get an import licence. If the applicant is a foreign business, the application must be submitted by an authorised agent. Agents who apply on behalf of foreign companies must have a valid wholesale licence for selling and distributing drugs. The Central Licensing Authority gives the import licence in form MD-15. Hence both Form MD-14 and MD-15 are very important in getting an Import License.
Conclusion
In order to import medical devices into India, one must first obtain a licence from the Central Drugs Standard Control Organization (CDSCO). It is vital to fulfil all of the required conditions in order to obtain the License. This includes filling out Form MD-14 and MD-15, submitting fees and the required documents, etc., with the assistance of an authorising agent. In order to obtain the License, it is important to fulfil all of the required conditions. The process of obtaining a licence is necessary, and failure to do so may result in barriers in the way of the import of medical devices in India.Â
Read our Article:What are Form MD-8 and Form MD-10?
