Medical Device Manufacturer License

What Is A Medical Device Manufacturer License?

Who is involved in manufacturing the medical device it may be either Any individual or company should apply for a medical device manufacturer license to commercialize or distribute the product. In India, many companies provide raw materials, semi-finished products, or components to customers. The CDSCO manufacturing license is essential to these companies to sell the finished medical device in India. 

Form MD 3 is an application to get a license, which is granted to a manufacturer for the manufacturing of low-risk and low to medium-risk medical devices. A license for manufacturing is granted through form MD 5 after the application is reviewed and approved by the CDSCO.

How To Register For CDSCO Medical Device Manufacturer License?

To register for a CDSCO license for manufacturing in India, an applicant has to follow a few steps first, as mentioned below:

  • Identify the type of  license,
  • Make sure your facility meets eligibility criteria and GMP guidelines,
  • Recruit qualified technical staff,
  • Depending upon the license required we need to submit an application that includes Form 27, prescribed fees, site master file, premises details, and manufacturing process information to the relevant State Drug Control Department or CDSCO

Procedure To get a CDSCO Medical Device Manufacturer License

  • Identify the class of medical device:  Based on their risk level the CDSCO classify the medical devices into four categories. The applicant should determine the class of device for which medical device they need to obtain a manufacturing license
  • Prepare the required technical document: Prepare all technical documents for the corresponding medical device which include the device description, manufacturing process, device specification, safety and performance data. Ensure the documentation meets the CDSCO requirements.
  • Submit the Application based on the medical device class: Submit the required CDSCO’s application based on the class of device to get a license for manufacturing. Along with the CDSCO application we require to include the technical documentation, a cover letter, and the required fees.
  • Application reviewed by the CDSCO: The CDSCO will review and examine the application and all the technical documentation. The CDSCO may issue a deficiency letter If it requires additional information.
  • Manufacturing Facility inspection: Once the CDSCO completes reviewing your application, it will inspect your manufacturing facility. After completing the inspection the result will determine whether the manufacturing facilities meet the CDSCO requirement or not.
  • Grant of Manufacturing License: If your manufacturing facilities complies the CDSCO requirement, it will issue the manufacturing license.
  • Renewal of license: The validity of the the manufacturing license is 5 years. So you must renew your manufacturing license before it expires.

Required Form To Obtain Medical Device Manufacturing License

The manufacturing license for class A & B medical devices is obtained from the State licensing authority. Forms MD-3 and MD-5 are used to obtain the license; the applicant must submit an application in Form MD-3 along with the previously mentioned technical document, and the license is obtained through Form MD-5.

The manufacturer must submit an online application using Form MD-7 via the Central Licensing Authority of the Ministry of Health & Family Welfare in the Central Government. Through this, applicants can get a Manufacturing License for class C and D medical devices. Central Licensing Authority granted a Medical Device Manufacturing License for the continued sale & distribution of Class C and  D medical devices through Form MD-9.

List Of Documents Needed To Get Manufacturing License For Medical Device

For the seamless processing of the medical device manufacturing license, you have to attach all the documents with the application form. The documents are as follows:

  • Application Form based on the class of medical device
  • ISO 13485 Certificate
  • Power of attorney
  • TR6 challan
  • Undertaking that only authentic details are provided
  • CE certificate
  • Quality assurance certificate
  • Conformity declaration
  • Device master file(DMF)
  • Plant master report(PMR)
  • Schedule D(I)
  • Free Sale Certificate

Overview Of Forms Md 3, Md 5, Md 7, And Md 9

To apply for the manufacturing license of medical devices let’s understand the types of forms that are mandatory to fill out to obtain the license:

CDSCO Form MD-3 and MD-5

The CDSCO have authority for regulating the import, manufacture, sale, and distribution of medical devices in India. Form MD 3 and Form MD 5 are two essential forms of this regulation. These two forms are important for obtaining the necessary licenses to operate legally within the medical device industry in India.

  • Form MD 3: It is the application form used to obtain a license to manufacture Class A or Class B medical devices for sale or distribution in India. Class A and B devices are respectively low and low to moderate-risk devices.
  • Form MD 5: It is the license issued to a manufacturer by the CDSCO for the production of Class A or Class B medical devices. When the CDSCO complete review and approval of application (typically using Form MD 3), the manufacturing license for the corresponding medical device is provided through Form MD 5. This license is a legal certification that the manufacturer has authority to produce specified medical devices under the MD Rules, 2017.

CDSCO Form 7 and MD 9

CDSCO forms such as Form MD 7 and MD 9 are used to regulate medical devices in India under the Medical Devices Rules, 2017. These two forms are an essential part of the regulatory framework that include the importation and distribution of medical devices.

  • Form MD 7: It is the application form used to get a license to manufacture Class C or Class D medical devices for sale or distribution.
  • Form MD 9: It is the license issued to manufacture for sale or distribution of Class C or Class D medical devices.

Procedure To Apply On the CDSCO Portal For Medical Device Manufacturer License

You need to follow the below steps, to apply for a manufacturing license for a medical device in India on the CDSCO portal: 

  • Go to the CDSCO online portal and create an account by using your email address.
  • After registering, login to the portal and select the “Online Application” section.
  • Go to the “Medical Devices” in the “Online Application” section, and then select the type of license you require to apply, for example manufacturing license for medical device.
  • Fill out the application form with the necessary details, such as the details of the CDSCO MD, quality control procedures, manufacturing facility and other pertinent information.
  • Upload the required documents, such as the application form, manufacturing plan, and product specifications.
  • Pay the application fee with the CDSCO portal’s online payment gateway.
  • After complete the submission of your application form, you have to wait for the CDSCO to review the application.
  • When your application is approved, the CDSCO will grant the manufacturing license for your medical device
  • It is important to ensure that you have all the  documents required by the CDSCO and meet all the requirements before submitting your application to the CDSCO.

The documentation and approval from the CDSCO take a long time. If they find any omission then they have the right to reject the application. So, you must consult with the medical device registration consultant before applying. They will guide you and file applications easily because of their professional experience.

Validity time for license

The validity of the medical device license is for five years which is received through forms such as Form MD-5, Form MD-6, Form MD-9 or MD-10. If the license is suspended or canceled by the authority, the applicant shall apply within 45 days from the date of the action.

Why Is A Manufacturing License Needed?

The main objective of getting a manufacturing license certificate is to regulate and control the manufacturing and distribution of goods to make sure that they complies the certain standards and requirements.

What Is The Cost Of Medical Device Manufacturer License In India?

It is based on the number of employees and the power of the machinery in the corresponding company. Normally the minimum cost is Rs 1,000 and can go up to Rs 500,000 for big factories.

How Do I Start Medical Device Manufacturing?

To start medical device startup require specialized measures such as identifying needs, validating ideas, building a skilled team, navigating regulations, securing funding, devising a market strategy, and fostering ongoing innovation.

Who Provides The Manufacturing License?

The Department of Legal Metrology provides the manufacturing license. Every Business interested in manufacturing a pre-packaged commodity or a calibrated instrument must obtain a manufacturing license.

Does Msme Require A Factory License?

Factory License Registration in state such as Karnataka is an important certification required by manufacturing industries, SMEs and Factories in Karnataka

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