The Ministry of Health and Family Welfare has issued a draft notification to update the Medical Devices Rules, 2017. These changes aim to make the registration process easier, improve the label clarity, strengthen testing and reporting, and reduce repeated licence renewals for the medical devices. The draft especially focuses on Class A medical devices that are non-sterile and non-measuring, making rules simpler and more practical for low-risk devices.

The amendment introduces clear rules for registration numbers, perpetual validity of licences, updated forms, and better testing reports. These steps support ease of doing business while ensuring patient safety. The changes also bring uniformity across manufacturing, import, inspection, and compliance activities.

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Why the Draft Medical Devices Rules Amendment are Introduced?

Medical device regulation in India continues to evolve. The growing number of manufacturers, importers, and startups required simpler and more transparent rules. Earlier systems focused mainly on licences, even for low-risk devices. This created delays and confusion. The amendment solves this problem by recognizing registration numbers for low-risk Class A devices. The draft removes the need for repeated renewals by allowing licences to stay valid for a long time, as long as the required retention fee is paid. It also improves testing and reporting by adding clear formats and defining the role of testing laboratories in a simple way. Overall, the amendment keeps people safe, maintains good quality, and makes compliance easier. It encourages new ideas and growth while keeping strong and reliable rules in place.

Major Changes Related to Registration and Labelling

One of the most important changes relates to Class A (Non-Sterile and Non-Measuring) medical devices. These devices now receive recognition through Registration Numbers instead of traditional licence numbers in many cases. Key labelling updates include:

• Rule 44 and Rule 45 now allow the use of “Registration Number” or “Reg. No.”
• Labels may show Registration Number instead of Manufacturing Licence Number.
• Import labels may also display the Registration Number for eligible Class A devices.

This change reduces paperwork and speeds up market entry for low-risk products. It also ensures clear identification of registered devices without compromising safety.

Perpetual Validity of Medical Device Licences and Registration

The important update or improvement made is the perpetual validity of licences. Earlier, licences had to be renewed repeatedly, even when nothing had changed. These draft amendment rules remove this extra work and allow licences to stay valid without any repeated renewals. Forms updated for perpetual validity include:

1. Form MD-2
2. Form MD-5
3. Form MD-6
4. Form MD-9
5. Form MD-10
6. Form MD-15
7. Form MD-40

Licences and registrations now remain valid for life unless they are suspended, cancelled, or surrendered. A small retention fee must be paid as per the Medical Devices Rules, 2017. This change lowers paperwork and helps manufacturers and importers plan their work with confidence for the long term.

Changes in Inspection, Testing, and Compliance

Proper testing and inspection of medical devices are important because they ensure that they are safe. The amendment introduces clear and simple rules to make these processes easier to follow. Key updates include:

• Inspection records must now be maintained using Form MD-11.
• Registration holders are now responsible for inspections, just like licence holders.
• The requirement for digital signatures in Form MD-11 has been removed.
• Inspection formats have been simplified to make compliance easier and more efficient.

Introduction of Form MD-44

A new form, Form MD-44, gets added for test or evaluation reports from registered medical device testing laboratories. Form MD-44 includes:

• Sample receipt details
• Precise details of the manufacturer and batch number
• Step-by-step test methods followed by the laboratory
• Results of physical, chemical, biological, and diagnostic tests
• A clear final opinion on the quality of the device

These details create clear, honest, and uniform test reports across all laboratories in India.

Schedule and Structural Changes in the Rules

The amendment also updates different schedules and chapters of the rules. These changes remove confusion, bring clarity, and make the rules easier to understand and follow. Important structural updates include:

• Removal of the term “Notified Body” from Chapter IX
• Second Schedule updated for overseas manufacturing sites for Class C and D IVD devices
• The Fifth Schedule is expanded to cover all medical devices and in-vitro diagnostic devices
• Environmental compliance standards are emphasized for all manufacturing activities

These changes align Indian rules with global best practices while maintaining local safety standards.

Updates in Forms and Appendices in Medical Device Draft Rules

The Draft Medical Devices Rules bring important updates to many forms and appendices, making them clearer, easier to use, and more consistent. The key updates include:

• Form MD-34 has been corrected to show the right legal section, making it accurate for official use.
• Forms MD-36, MD-37, and MD-38 now include structured tables to record key details about samples, including device name, batch number, manufacturing information, and expiry dates.
• Important details like quantity, batch number, manufacturing date, and expiry date are now added clearly in the forms. 

These changes improve device traceability, support proper documentation, and make inspections and testing more reliable.

Impact of Draft Rules on Stakeholders 

The amendment strengthens the entire medical device system and creates clear value for everyone involved.

Benefits for Manufacturers: Manufacturers now deal with fewer renewals, which saves time and reduces extra work. Simple compliance rules make approvals faster. Clear labelling rules also help avoid mistakes during manufacturing and sale.
Benefits for Importers: Importers benefit from easy and clear import labelling norms. The rules also straightforwardly explain overseas manufacturing conditions, helping imports stay safe, legal, and well-controlled.
Benefits for Testing Laboratories: Testing laboratories now utilise a single, common reporting format. The Form MD-44 provides strong legal support for test reports, ensuring results are reliable and consistent nationwide.
Benefits for Patients and Healthcare Providers: Patients and healthcare providers get safer and better-quality medical devices. Clear testing, accurate records, and strict inspections ensure trust and keep high safety standards in the healthcare system.

Conclusion

The Draft Medical Devices Rules are a wise and important step towards simpler, smarter rules and regulations for medical devices in India. The rules make registration easier for low-risk devices (Class A), remove the repeated licence renewals, and introduce perpetual validity, including retention fees. Stronger testing standards, clear labelling rules, and the introduction of the new Form MD-44 ensure correct evaluation and reliable reporting of the medical devices.

Updated schedules and improved forms in the draft rules make the record-keeping and compliance easier, by supporting both manufacturers and importers in planning long-term operations. The amendment rules strengthen patient safety, improve device quality, and encourage innovation in the medical device sector.

The Draft Medical Devices Rules create a simple, safe, and supportive system for medical devices in India. They guide the industry to follow global standards while making sure quality and patient safety come first. These changes make the medical device sector more reliable, organized, and easy to manage, creating a well-regulated environment for manufacturers, importers, and healthcare providers alike.