What are Form MD 5 and Form MD 9?

If you want to manufacture medical devices in India, you need the right licenses from the CDSCO. Forms MD 5 and MD 9 are two main approvals under the Medical Device Rules, 2017. MD 5 is for low-risk devices, whereas MD 9 is for high-risk ones.

These licenses ensure that your manufacturing process meets national safety and quality builds trust in the healthcare market. Now, check out the article to know the validity, procedure, and all the important details related to Form MD 5 and Form MD 9. 

What is Form MD-5 in Medical Device Manufacturing Licensing?

Form MD-5 in medical device manufacturing licensing is the official license issued by the CDSCO to Indian manufacturers of Class A and Class B medical devices. This form is granted after reviewing the manufacturer’s applications and confirming that their facility meets all the quality, safety, and documentation requirements under the Medical Device Rules, 2017. 

• It is issued after submitting Form MD-3 and a successful inspection of the manufacturing site.
• It is applicable only for Class A and Class B (low to moderate risk) devices.
• The state licensing authority grants the license.

What is Form MD 9 in the CDSCO Medical Device Regulations?

Form MD 9 in the CDSCO medical device regulations is the official manufacturing license issued under Class C and Class D medical devices in India. These are high-risk devices like implants, diagnostic imaging systems, heart valves, etc. 

This license is granted by the Central Licensing Authority after carefully reviewing the manufacturing site, documents, and product safety standards.

• It is issued after submitting the form MD 7 with all required documents
• Applicable only for Class C and Class D medical devices (moderate to high risk)
• Inspections are conducted by CDSCO officials before issuing the license
• It is mandatory to have form MD 9 to manufacture or market these devices in India

What is the Difference Between Form MD 5 and Form MD 9?

Please look at the table to know the difference between Form MD 5 and Form MD 9:

S.No.	Comparison	Form MD 5	Form MD 9
1.	Purpose	License for manufacturing class A & B devices	License for manufacturing class C & D devices
2.	Issued By	State Licensing Authority	Central Licensing Authority
3.	Application Form Used	Submitted via Form MD 3	Submitted via Form MD 7
4.	Regulatory Authority	State Drug Controller Under CDSCO Supervision	CSDCO Central Drugs Standard Control Organisation
5.	Inspection Responsibility	State-level drug inspectors	CDSCO appointed central inspectors
6.	Processing Time	Usually faster	It may take longer due to higher risk and central approval
7.	Applicable Manufacturers	Local manufacturers of simpler or general-use devices	Manufacturers of complex, high-risk medical equipment
8.	Examples of Device	Thermometers, surgical gloves, tongue depressor, BP monitors	Pacemakers, heart valves, X-ray machines, blood analyzers

Who Needs To Apply For Form MD 5 for Medical Devices in India?

Any Indian manufacturers who want to produce Class A or Class B medical devices should apply for Form MD 5. These are low to moderate risk devices, like surgical gloves, digital thermometers, BP monitors, or syringes. The license ensures that the manufacturing unit follows all safety, quality, and labelling rules under the Medical Device Rules, 2017.

Who is Required to Obtain Form MD 9 For Medical Device Manufacturing?

Any manufacturers in India who want to produce Class C or Class D medical devices should get a license through Form MD 9. These devices are considered moderate to high risk, for example, X-ray machines, ventilators, pacemakers, heart valves, or blood analysers. Because of the risk involved, these products need central approval from the CDSCO. 

What is the Application Process For MD 9 in CDSCO Licensing?

Here we have listed the easiest application procedure for MD 9 in CDSCO licensing:

1. Check Product Classification – First, confirm that your product falls under Class C and Class D as per the CDSCO medical device classification.
2. Pre-approval Required Documents – Collect all required documents like Device Master File, plant master file, company registration, quality certificates, etc.
3. Register on the CDSCO SUGAM Portal – Create an account on the SUGAM portal, which is CDSCO’s official online platform for licensing.
4. Fill & Submit Form MD 7 – Fill form MD 7 online on the SUGAM portal to apply for the manufacturing license of class C & D devices.
5. Upload All Supporting Documents – Upload documents like site details, product specs, quality SOPs, QMS certification, etc. 
6. Pay the Government Fees – Provide the required license fee online. The amount typically depends on the number and types of devices you are applying for.
7. Manufacturing Site Inspection – CDSCO may assign an inspector to visit your facility to check compliance wth good manufacturing practices (GMP)
8. Grant of MD 9 License – Once everything is fine, CDSCO will issue form MD 9, officially permitting you to manufacture the listed class C & D devices.

Documents Required to Apply for Form MD 5 for Medical Device Manufacturing

Here we have listed all the imported documents required to apply for Form 5 for medical device manufacturing:

• Duly Filled Form MD 3 
• Copy of Company Incorporation Certificate/MSME Registration
• Copy of PAN Card of the Company
• GST Registration Certificate
• Site Master File
• Plant Master File
• Copy of QMS Certificate
• Details of Equipment  & Machinery Installed
• Environmental Clearance Certificate
• List of Technical Qualification Certificate
• Organogram of the Company
• Device Master File
• Product Specification & Label Design
• Instruction for Use
• Clinical Evaluation Report
• Undertaking for Post Market Surveillance & Vigilance
• Self-Declaration for Compliance with MDR 2017

Validity Period of Form MD 5 License For Medical Device Manufacturing

Certainly, the Form MD 5 license issued for the manufacturing of Class A and Class B medical devices is valid for 5 years from the date of issue.