What is Form MD-4 and Form MD-6?
The Medical Devices Rules, 2017 were notified by the Ministry of Health and Welfare to put in place certain standards to regulate the use of medical devices and to ensure that medical devices meeting exacting standards of quality and safety were being employed in the healthcare industry. Medical devices which are to be manufactured need to be registered as per the Rules. The Rules state that the manufacturers of medical devices must obtain manufacturing permission based on the risk associated with the device. The Rules also mandate that manufacturers of medical devices who want to obtain loan licenses manufactured for sale or distribution need to apply to the concerned authority. The Rules make it mandatory for such manufacturers that require loan licenses to manufacture medical devices for sale or distribution to file applications in accordance with the Rules. Scroll down to check more about Form MD-4 and Form MD-6.
The medical devices are divided into four classes, namely, Class-A, Class-B, Class-C and Class-D, based on the risk element associated with them. Applications under Form MD-4 and Form MD-6 pertain to medical devices from Class-A contains minimal-risk devices and Class-B contains devices which are considered to fall in the range of low to moderate-risk devices. Class- contains devices where the risk is moderate to high, and Class-D contains high-risk devices.
Form MD-4 and Form MD-6 – Meaning
The Application for a loan license can be filed Application by filling in Form MD-4 and Form MD-6 for the grant of loan licenses. Form MD-4 pertains is the “Application for grant of loan license to manufacture for sale and distribution or for distribution for Class-A or Class-B medical devices” and Form MD-6 pertains to the approval form for the loan license, namely, “Loan license to manufacture for sale and distribution or for distribution for Class-A or Class-B medical devices.
The State Licensing Authority and the Central Licensing Authorities are responsible for granting licenses pertaining to medical devices based on the classes they are categorized into. While the Central Licensing Authority regulates the manufacture, loan and retention of licenses for medical devices falling under Class-C and Class-D, the State Licensing Authority regulates licensing of medical devices falling under Class-A and Class-B. Hence, the State Licensing Authority of the state where the manufacturing entity is situated shall be the one granting loan licenses under Form MD-4 and Form MD-6.
Essential Documents Required While Filing Form MD-4 and Form MD-6
There are certain documents required while filing an application to obtain a loan license for the manufacture of medical devices for sale or distribution using Form MD-4 and Form MD-6. The following documents must be submitted along with the Application:
- A cover letter stating the intention of the Application
- Declarations as to information regarding the partners, directors, and proprietors of the manufacturing entity as per Affidavit-1.
- An attested copy of the partnership deed or the Memorandum of Association or the PAN, whatever is applicable, shall be submitted with the affidavit.
- Proof of ownership of the manufacturing site, like a sale deed or lease agreement
- A notarized document with details and photographs of persons involved in carrying out the day-to-day activities of the entity and details as to conduct of the business of the entity.
- Test license obtained from the Central Drug Standard Control Organization (CDSCO)
- Details of any previous CSDCO loan license applied for
- Letter of consent from the parent company, if any, as to the CDSCO license details issued already and ratifying the availability of resources.
- Details of the technical staff involved in the production process
- New test methods, products and ingredients used are not present in any drug standard compendium.
- A flow chart showing the procedure involved in the production, effluents used in the treatment
- Declarations pertaining to formulations prohibited by the concerned authority earlier or not applicable earlier and any packaging details along with all the formulations involved.
- Quality Management System certificate
- Device master file
- Plant master file
Procedure for Obtaining Loan License for Medical Devices using Form MD-4 and Form MD-6
Any entity looking to obtain a loan for the manufacture of medical devices for sale or distribution must fill out Form MD-4 in the following manner:
- Registration with the Ministry of Health and Family Welfare on the Sugam Portal
The manufacturer of medical devices looking to obtain loan licenses for the manufacturing of medical devices for sale or distribution must be registered with the Ministry of Health and Family Welfare.
- Filling up Form MD-4
The applicant must fill out Form MD-4 and upload it on Sugam Portal along with all required documents as per the checklist provided under Form MD-4 and other information. The applicant must also pay the requisite prescribed fee (Rupees Five Thousand for registration of the plant or Rupees Five Hundred per device)
- Application scrutiny by State Licensing Authority
Once the Application has been duly submitted with the relevant documents, the State Licensing Authority shall assess the documents as to their sufficiency and accuracy of the same.
- Grant of Loan License
If the State Licensing Authority approves the Application, the loan license shall be granted under Form MD-6.
If the Application is rejected, the State Licensing Authority must inform the manufacturing entity within 45 days of the rejection and the entity can apply for a license again after the expiry of the said 45 days.
While applying for a license, the manufacturing entity must make sure that the manufacturing premises conform to the standards under Quality Management Systems as provided for under the Fifth Schedule.
The average time expended in obtaining a loan license for medical devices is up to four to five months.
Validity of Loan License
The loan license for medical devices is valid in perpetuity. However, periodic retention fees must be paid every five years, failing which, the license shall stand cancelled.
The Ministry of Health and Welfare, through the Medical Devices Rules, 2017, has mandated that medical devices have to be registered with the requisite authority and manufacturers of such medical devices must obtain requisite licenses to manufacture, obtain loans from the State Licensing Authority or the Central Licensing Authority based on the risk class the medical device falls in. To obtain a loan license for medical devices falling under Class-A and Class-B, applications must be filled in accordance with Form MD-4 and submitted to the appropriate State Licensing Authority and the license, once approved, shall be granted under Form MD-6. Only after the grant of such a license will manufacturers of medical devices for sale or distribution be eligible to apply for a loan.
Read our Article:What is the Meaning of FORM MD-7 and FORM MD-9?