CDSCO Registration for Custom-Made Medical Devices

CDSCO registration for custom-made medical devices is important for ensuring that personalized medical solutions like prosthetic limbs are safe. These devices, such as dental implants or orthopedic devices, are not mass-produced but are specially designed for a single patient based on the doctor’s prescription. This blog will help you to know the registration procedure in simple steps, important documentation, its timeline, and more.

What is CDSCO Registration for Custom-Made Medical Devices?

CDSCO Registration for custom-made medical devices is the official approval process by the Central Drugs Standard Control Organization for devices that are specially designed and manufactured for a specific patient based on a medical professional’s prescription. The devices are not mass-produced but are tailor-made to fit the unique needs of one individual, for example, custom dental implants, prosthetic limbs, or orthopedic braces made to match the patient’s body. 

• Safe and medically justified
• Manufactured under a quality standard
• Used only for individual patients 

To get CDSCO registration, the manufacturer or importer should provide documents such as design details, GMP compliance, and a copy of the medical prescription

Who Needs CDSCO Registration For Custom-Made Medical Devices in India?

Any manufacturer or importer who designs or supplies custom-made medical devices in India needs CDSCO registration.

1. Indian Manufacturers – If you are a medical device manufacturer in India and you create custom-made devices like dental implants, orthopedic braces, or prosthetic limbs, based on a doctor’s prescription for one specific patient, then you should register the device with CDSCO under the Medical Device Rules, 2017.
2. Importers of Custom-Made Devices – If you’re importing a custom-made medical device from another country into India for a single patient’s use, you are required to get CDSCO permission before bringing it into the country
3. Hospital or Clinics Manufacturing Devices In-house – If a hospital or clinic has an in-house facility that manufactures or customizes devices for specific patients, the CDSCO registration is required.
4. Medical Device Designers and Developers – Individuals or companies involved in designing and developing these patient-specific devices must also ensure that their products are registered and follow CDSCO compliance rules. 

Why Is CDSCO Registration Mandatory For Custom Made Medical Devices?

Even though custom made medical devices are designed for just one patient, they still come in direct contact with the human body and can affect a person’s health, safety, and recovery. That’s why CDSCO registration is mandatory to make sure these devices are safe, effective, and made under proper medical supervision. 

1. To ensure patient safety – Each device is made for a specific person, but if poor quality materials or unsafe design are used, it can cause harm. Registration makes sure only approved devices are used.
2. To prevent misuse or poor manufacturing – Without regulation, anyone could claim to make a medical device. CDSCO registration ensures that only qualified and authorized manufacturers or importers are involved.
3. To keep medical professionals accountable – Doctors or surgeons prescribing customs devices should explain why it is needed. This prescription is part of the CDSCO process, adding professional responsibility.
4. To follow legal requirements – According to India’s Medical Device Rules, 2017, even custom made devices should follow certain safety, labeling, and documentation guidelines. 

What Are the Regulatory Guidelines For CDSCO Registration of Customs-Made Medical Devices?

The CDSCO has a set of specific rules under the Medical Device Rules, 2017 for custom-made medical devices to ensure they are safe and made responsibly. 

• Definition Should be Met
• No Mass Production Allowed
• Written Prescription is Mandatory
• Labeling Requirements
• Form MD 29 Submission
• No CDSCO License Required, But Notification is a must

What is the Process for CDSCO Registration of Custom-Made Medical Devices?

The CDSCO registration process for customs made medical devices is easier than regular devices, but still needs proper documentation and compliance. 

• Check Eligibility – In the first step, make sure that your device qualifies as a custom-made medical device; it should be designed only for one specific patient, based on a written prescription from a registered medical practitioner.
• Prepare Required Documents – Check the next answer for important documents.
• Submit Form MD 29 – Here, you have to notify the CDSCO or state licensing authority by submitting Form MD 2,9, which is a declaration that your device is custom-made and not meant for mass distribution.
• Maintain Records – Although no formal license is needed, you should maintain detailed records of who the device was made for, the doctor who prescribed it, manufacturing and testing details, and delivery confirmation to the concerned patient
• Follow Labeling Rules – Make sure the device label includes, name of the patient, the name and contact of the prescribing medical practitioner, note “custom-made device”, and warning “not for commercial sale”.

What Documents Are Required for CDSCO Registration of Custom-Made Medical Devices?

Although custom-made medical devices do not require a formal CDSCO license, you still need to submit a notification (form MD 29) and maintain proper documentation to stay compliant with CDSCO standards.

• Prescription from a Registered Medical Practitioner
• Device Design and Specifications
• Patient Details
• Declarations in Form MD-29
• Manufacturing/Import Details
• Quality and Safety Assurance
• Patients Consent Form 
• Labeling Details
• Custom-Made Device
• Manufacturing/Importing entity name and address
• Delivery Record

How Are Customs-Made Medical Devices Classified Under the CDSCO Regulations?

Under CDSCO regulations, custom-made medical devices are exempted from the regular medical device licensing process, but they are still regulated.
Definition Under CDSCO

• Made specifically for a particular patient
• Based on a written prescription from a registered medical practitioner
• Design to meet the unique anatomical or physiological features of those patients
• Not mass-produced or commercially available 
• Labeling Classification 
• Risk Classification

Timeline For CDSCO Registration For Customs-Made Medical Devices

The timeline for CDSCO registration of custom-made medical devices usually differs. However, it takes 7 to 15 working days after submission of Form MD 29. 

Fees are Involved in CDSCO Registration for Customs-Made Medical Devices

Basically, the fee required for CDSCO registration for custom-made medical devices varies for several reasons. You can consult a trusted regulatory consultancy to know everything regarding your concern. 

Common Mistakes to Avoid During CDSCO Registration For Customs-Made Medical Devices

Check out this table mentioned below to know the common mistakes you must avoid during CDSCO registration for custom-made medical devices:

Why Choose ELT Corporate for CDSCO Registration For Custom-Made Medical Devices?

Here at ELT Corporate, we understand that registering custom-made medical devices under CDSCO includes precision, regulatory knowledge, and timely execution. Our expert team is here to make the procedure smooth and compliant.

• Expert Consultation
• Preparation and Filing of Form 29
• Regulatory Guidance
• Support for Manufacturer Verification
• Quick & Compliant Submission