Understanding MD-5 vs. MD-6 is important for medical device manufacturers in India. These applications serve different purposes under the medical device regulatory framework. Choosing the correct application depends on your device classification, manufacturing arrangement, and applicable CDSCO requirements.
Medical device manufacturers in India must follow the applicable requirements under the Medical Devices Rules, 2017 before manufacturing regulated products for sale or distribution. Understanding MD-5 vs MD-6 helps manufacturers choose the correct licensing route and prepare the right application.
The two forms serve different purposes. MD-5 is a regular manufacturing licence, while MD-6 is a loan manufacturing licence. The correct route depends on how the manufacturing activity is arranged, the device’s classification, and the applicable regulatory requirements.
What Is MD-5 vs MD-6 for Class A and B Medical Devices?
The difference between MD-5 and MD-6 is mainly related to the type of manufacturing licence required.
- MD-5: Licence for regular manufacturing of eligible Class A and Class B medical devices.
- MD-6: Loan licence for eligible Class A and Class B medical devices when the applicant uses another manufacturer’s licensed manufacturing facility under the applicable arrangement.
Both licences fall under the Medical Devices Rules, 2017. The application process and supporting documents depend on the applicant’s manufacturing arrangement and product requirements.
MD-5 vs MD-6: Key Differences
| Particulars | MD-5 | MD-6 |
| Type of licence | Regular manufacturing licence | Loan manufacturing licence |
| Application form | MD-3 | MD-4 |
| Main purpose | Manufacture devices under the applicant’s manufacturing arrangement | Manufacture devices using another manufacturer’s facility under a loan-licence arrangement |
| Relevant device classes | Eligible Class A and B | Eligible Class A and B |
| Licensing authority | State Licensing Authority | State Licensing Authority |
| Facility arrangement | Applicant’s own manufacturing arrangement | Another manufacturer’s facility, subject to applicable requirements |
The forms and licensing route are identified in CDSCO’s official medical device regulatory materials.
Which Medical Devices Fall Under Class A and Class B?
Before choosing between MD-5 and MD-6, you should confirm the risk class of your product.
Class A medical devices
Class A devices are generally considered low-risk medical devices. Their regulatory requirements depend on their characteristics and intended use. Some examples may include certain simple surgical instruments and non-sterile, non-measuring products. However, the actual classification must be verified against the applicable CDSCO classification list.
Class B medical devices
Class B devices are generally considered low-to-moderate-risk medical devices. Depending on the product, examples may include certain monitoring or diagnostic devices.
Class A and Class B products do not all follow identical requirements. Always check the official risk classification and the applicable licensing provisions before filing an application.
Is a licence required for every Class A device?
No. Certain Class A non-sterile and non-measuring medical devices are exempt from the standard licensing requirement under the applicable provisions and follow a separate registration route. This exemption should not be assumed to cover all Class A products.
MD-3 vs MD-4: Which Application Form Should You Use?
A common source of confusion is whether MD-5 or MD-6 is the application form. Neither is the application form.
When should you use Form MD-3?
Use Form MD-3 when applying for a regular manufacturing licence for eligible Class A or Class B medical devices.
The application should include the relevant details about the applicant, manufacturing premises, medical devices, and supporting compliance documents.
When should you use Form MD-4?
Use Form MD-4 when applying for a loan manufacturing licence for eligible Class A or Class B medical devices.
This route may be relevant when the applicant intends to manufacture products using another manufacturer’s facility under an appropriate arrangement. The parties must satisfy the applicable regulatory conditions.
The State Licensing Authority evaluates the application and grants the relevant licence when the prescribed requirements are fulfilled.
Documents Required for MD-5 and MD-6
When comparing MD-5 vs MD-6, review the applicable application requirements, device details, quality management documentation, and manufacturing information. The exact documents depend on the application route and the manufacturer’s circumstances.
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The documents required for a manufacturing licence depend on the product, facility, applicant, and applicable provisions. The following are common document categories to prepare.
Common documents
- Company incorporation or constitution documents
- Applicant and authorised signatory details
- Manufacturing premises address and facility information
- Medical device name, intended use, and classification
- Product specifications and technical information
- Manufacturing process details
- Quality management system documents
- Labelling and packaging information
- Testing, validation, and risk management records, where applicable
- Documents required under the applicable Schedules of the Medical Devices Rules, 2017
Additional documents for MD-6
For a loan licence, additional documentation may be required to establish the manufacturing arrangement and the applicant’s right to use the other manufacturer’s facility. This may include relevant consent or agreement documents, details of the facility, and supporting quality and manufacturing records.
Note: This is a general preparation checklist, not an exhaustive statutory list. Confirm the current checklist for your specific product and application route before filing.
How to Apply for an MD-5 or MD-6 Licence
The following steps provide a simple overview of the process.
Step 1: Identify the device classification
Check whether your product falls under Class A or Class B using the applicable CDSCO risk classification. If its classification is unclear, seek clarification through the prescribed regulatory process.
Step 2: Select the correct licence route
Decide whether your business requires a regular manufacturing licence or a loan licence. Review the manufacturing arrangement before choosing MD-3 or MD-4.
Step 3: Prepare the documents
Collect the company, facility, product, technical, quality, and other applicable documents. Ensure that the information is consistent across the application and attachments.
Step 4: Submit the application online
Prepare and submit the appropriate application through the designated medical device online system, along with the prescribed fee and supporting documents.
Step 5: Respond to regulatory queries
The licensing authority may review the submission and seek clarification or additional information. Respond accurately and provide the requested documents within the applicable timeframe.
Step 6: Complete applicable audit requirements
Audit requirements depend on the device class and applicable rules. For Class B manufacturing, the rules provide for an audit by a registered Notified Body. Eligible Class A devices are subject to the relevant requirements and applicable exemptions.
Step 7: Obtain the applicable licence
If the application meets the prescribed requirements, the State Licensing Authority may grant the relevant licence in Form MD-5 or MD-6.
How Long Does the MD-5 or MD-6 Process Take?
The processing time depends on the application type, document completeness, product classification, audit requirements, and any regulatory queries.
For Class B applications, the Medical Devices Rules provide specific stages for the Notified Body audit, report submission, and the licensing authority’s decision. Class A applications have separate provisions. These statutory stages should not be treated as a guarantee of the total time required for every application.
For a more accurate estimate, review the applicable rules and current portal requirements before planning a commercial launch.
Common Mistakes to Avoid
When comparing MD-5 vs MD-6, manufacturers should avoid these common mistakes:
- Confusing the licence form with the application form.
- Choosing the wrong licence route for the manufacturing arrangement.
- Assuming all Class A devices require the same licensing process.
- Using an incorrect or unverified device classification.
- Submitting incomplete technical or quality documentation.
- Providing inconsistent information about the applicant, facility, or product.
- Overlooking applicable audit requirements.
- Relying on outdated regulatory checklists.
Reviewing the application before submission can help reduce avoidable errors and regulatory queries.
Conclusion
Understanding MD-5 vs MD-6 is important for businesses planning to manufacture Class A or Class B medical devices in India. MD-5 is the regular manufacturing licence, while MD-6 is the loan manufacturing licence. Their corresponding application forms are MD-3 and MD-4.
Before applying, confirm the product’s risk classification, the manufacturing arrangement, the required documents, and the applicable regulatory conditions. Correct preparation can help prevent avoidable errors and support a smoother licensing process.
How ELT Corporate Helps with MD-5 and MD-6 Licensing
ELT Corporate supports medical device manufacturers and businesses that need assistance understanding the applicable CDSCO licensing process.
Our support can include:
- Licence route guidance: Help identify whether the regular manufacturing or loan-licence route may apply.
- Document preparation: Assist with organising company, manufacturing, product, and quality documentation.
- Application support: Help prepare the relevant application and supporting information.
- Compliance review: Help identify documentation gaps and applicable regulatory requirements.
- Query assistance: Support preparation of responses to regulatory queries.
- Ongoing guidance: Help businesses understand relevant licensing and compliance obligations.
The final licensing decision rests with the competent regulatory authority. Requirements depend on the product and its manufacturing arrangement.
For assistance, visit MedicalDeviceRegistration.com and contact ELT Corporate about your medical device licensing requirements.
Frequently Asked Questions
Q1. What is the main difference between MD-5 and MD-6?
MD-5 is the regular manufacturing licence for eligible Class A and Class B medical devices. MD-6 is a loan manufacturing licence for the applicable manufacturing arrangement.
Q2. Which application form is used for MD-5?
Form MD-3 is used to apply for a regular manufacturing licence, which may be granted in Form MD-5 after the applicable requirements are met.
Q3. Which application form is used for MD-6?
Form MD-4 is the application for a loan manufacturing licence, which may be granted in Form MD-6.
Q4. Who issues MD-5 and MD-6 licences?
The State Licensing Authority is responsible for the applicable Class A and Class B manufacturing licence pathway, subject to the relevant rules and exemptions.
Q5. Can a startup apply for an MD-5 licence?
A startup may apply if it meets the applicable eligibility, facility, documentation, quality, and other regulatory requirements.
Q6. Can I use another manufacturer’s facility for MD-6?
A loan-licence route may allow manufacturing through another manufacturer’s facility, subject to the applicable regulatory conditions and supporting documentation.
Q7. Are all Class A medical devices required to obtain MD-5?
No. Certain Class A non-sterile and non-measuring devices are exempt from the standard licensing requirement under applicable provisions. Verify the current requirements for your particular device.
Q8. Is an audit required for Class B medical device manufacturing?
The Medical Devices Rules provide for an audit of the manufacturing site by a registered Notified Body for applicable Class B manufacturing licence applications.
Q9. How long does it take to obtain MD-5 or MD-6?
The time varies according to the application, document completeness, audit requirements, and regulatory queries. Check the applicable statutory timelines rather than relying on a guaranteed processing period.
Q10. Can ELT Corporate help with MD-5 and MD-6 applications?
ELT Corporate can assist with understanding the licensing route, preparing documentation, reviewing compliance requirements, and providing application support. Licence approval remains the responsibility of the competent authority.
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