Form MD 7 and MD 9 are essential for obtaining in the medical device manufacturing industry. If you are a manufacturer of medical device Class C & D then securing medical device manufacturing license is mandatory to ensure compliance with the regulatory standards.
The process of obtaining a medical device manufacturing license starts with the Form MD-7, application form for manufacturing license, upon approval, leads to the issuance of MD 9 by the Central Licensing Authority.
This approval follows a thorough inspection of your manufacturing site to verify adherence to safety and quality regulations. Understanding Form MD 7 and MD 9 is crucial for a smooth and successful certification process.
What Is Form MD 7 and MD 9 In Medical Device?
Form MD-7 – It is an application form filled & submitted by the manufacturer or business owner. It is filled to obtain a manufacturing license from the Central Licensing Authority for the manufacturing of class C and D medical devices. Form MD-7 is the important step in ensuring that the manufacturing process adheres to the regulatory standard as per the Medical Device Rules, 2017.
Form MD-9 – It involves the manufacturing license certificate issued by the Central Licensing Authority in India, for manufacturing the medical devices of class C and D. After reviewing the complete application Form MD-7 and successful inspection of the manufacturing site, the regulatory authority issues a manufacturing license under MD-9, ensuring manufacturing process compliance meet the quality and safety standards.
Who Can Apply For MD-9 License In India?
Manufacturer, who wants to manufacture and sell medical devices of class C and D category can apply for an MD-9 manufacturing license.
Companies who want to manufacture class C and D medical devices on their manufacturing premise can apply for an MD-9 license.
Why Do You Need an MD-9 License?
To manufacture the medical device of class C and D category or in-vitro diagnostic medical devices legally in India, the manufacturing license is mandatory to obtain under Form MD-9.
What Are The Essential Documents Required To Obtain Manufacturing License Under Form MD-9?
Following are the key documents an applicant must submit to obtain the manufacturing license under MD-9, in accordance with the CDSCO, Medical Device Rules, 2017:
- Form MD-7
- Device Master File
- Site Master File
- ISO 13485 Certificate
- Fee Receipt
- Company Details
- Memorandum of Association
- Performance Evaluation Report
- Test License
What Are The Prerequisites for an MD-9 License?
The following are the Pre-requisites an applicant shall meet to obtain an MD-9 license:
- Quality Management System (QMS) compliance as per ISO 13485:2016.
- Adequate infrastructure and qualified staff.
- Necessary documents, including site master file, device master file, and essential safety and performance data.
Procedure For The Grant Of MD-9 License
Below are the steps that an applicant shall follow for a seamless grant of a manufacturing license:
- Step 1: Visit the SUGAM portal and register yourself.
- Step 2: Fill out the application form MD-7 and submit it through the SUGAM portal.
- Step 3: Upload and submit the required documents including the site master file, test license, device master file, etc.
- Step 4: Pay the applicable fees.
- Step 5: The application will be reviewed by the Central Licensing Authority and if the application is found as per the standard requirement, it will proceed further for quality management system (QMS) compliance.
- Step 6: Inspection by the notified body officer. If the manufacturing premise is found in compliance with the regulatory requirements, the application will proceed further otherwise if found non-compliance, then you need to submit a non-compliance closure report to the regulatory authority.
- Step 7: Once all the requirements are found in compliance with the regulatory requirements, the Central Licensing Authority will issue the manufacturing registration license for class C and D of medical devices under Form MD-9.
What Are The Required Fees For an MD-9 License?
Fees for an MD-9 license as per Medical Device Rules, 2017, for the manufacturing of class C and D medical devices is ₹ 50000/ per manufacturing site inspection and ₹1000/ for each medical device.
What Is The Validity Of MD-9 License?
The manufacturing license issue under Form MD-9 remains valid for a long time unless the applicant pays the retention fees every five years.
What Is The Timeline For Obtaining MD-9 License?
It generally takes 45 working days for the grant of manufacturing license of class C and D medical device under MD 9 from the date of successful inspection from the Central Licensing Authority.
How We ELT Corporate Can Assist You With MD-9 License?
We, ELT corporate with deep industry knowledge and expertise can help you in granting of manufacturing license under Form MD-9 for the manufacturing of class C and D medical devices. Let’s collaborate for a smooth and seamless process of obtaining a manufacturing license and to drive your success and meet regulatory compliance. Our offering includes:
- MD-7 Submission
- ISO 13485: QMS Certificate
- Audit Preparation
- CDSCO, SUGAM Portal Queries Response
- GMP Certificate
How Long Does It Take to Obtain Manufacturing License For Class C And D Medical Devices Under Form MD 9?
It depends on the organization and how they work, generally, it takes 45 days for the grant of manufacturing license for class C and D medical devices under MD-9 after the inspection from the Central Licensing Authority.
When is the Inspection Of the Manufacturing Site For Class C and D Medical Devices Conducted By The Licensing Authority?
After the submission of MD 7, within sixty days inspection of the manufacturing site is conducted for class C and D medical devices.
How Many Members Are There In the Audit Team As Per Medical Device Rules, 2017?
There are a minimum of two medical device officers, with or without an expert, or notified body officer.
Where One Can Find Detailed Information About Form MD-9?
Detailed information can be found on the CDSCO portal or one should contact us for proper guidance on manufacturing licenses for class C and D medical device.
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