What is SKD Registration for Medical Device Accessories?

Let’s understand what SKD registration for medical device accessories means and why it’s important in India. If you’re importing or assembling medical devices using semi-knocked-down parts, you should follow the CDSCO rules to ensure legal and safe operation. SKD registration for medical device accessories is required when you bring partially assembled devices into India for final assembly. Even if you are a manufacturer or importer, registering these SKD parts with CDSCO is important under the Medical Device Rules, 2017. 

What Does SKD Mean in Medical Device Manufacturing?

In medical device manufacturing, SKD stands for semi-knockdown. It means a device or its accessories are partially assembled in another country and then imported into India for final assembly or testing. If these SKD parts are used to make a regulated medical device or accessory, they should be registered with the CDSCO before import and sale. This makes sure the final product still follows all Indian medical device rules for safety and quality.

When is SKD Registration Required for Medical Device Accessories?

SKD registration is required when semi-knocked-down (SKD) parts or accessories are imported into India to assemble a medical device that the CDSCO regulates. Suppose the final assembled product is a notified medical device or accessory under the Medical Device Rules, 2017. In that case, the importer or manufacturer has to register the SKD parts with the CDSCO before importing or selling them. This ensures that all parts used in the device meet safety and quality standards set by the government. 

Are Medical Device Accessories Treated as Medical Devices Under CDSCO?

Yes, medical device accessories are treated as medical devices under CDSCO if they are essential for the device’s intended use. If an accessory helps the medical device work properly, for example, a sensor cable, battery pack, or software, then it is regulated as a medical device. This means it should follow the same registration and safety rules, including SKD registration, if imported in parts.

Who Regulates SKD Registration for Medical Device Accessories in India?

SKD registration for medical device accessories in India is regulated by the CDSCO. CDSCO works under the Ministry of Health and Family Welfare and is the main authority responsible for ensuring that all medical devices, including SKD parts and accessories, meet proper safety, quality, and regulatory standards before being imported and sold, or used in India.

What is the Role of the Medical Device Rules, 2017, in SKD Registration?

The Medical Device Rules (MDR), 2017, play an important role in the SKD registration of medical device accessories in India. These rules set the legal and regulatory framework for importing, manufacturing, and selling medical devices, including devices in semi-knockdown form.

What is the Procedure for SKD Registration for Medical Device Accessories?

Here we have mentioned the easy procedure for SKD registration for medical device accessories:

• Check Product Classification – First, you have to confirm that your accessory or SKD part is classified as a medical device under MDR, 2017. Determine its risk class (A, B, C, or D).
• Appoint Authorized Agent (For Importers) – If you’re an importer, appoint an Indian Authorized Agent who will apply on your behalf.
• Prepare the Required Documents – Now, collect all the documents such as a covering letter, product description, SKD components list, and more. You can check the next answer to know the complete list.
• Apply Through CDSCO’s SUGAM Portal – Now, you have to apply online.

1. Form MD – 3 (For Indian Manufacturers – Class A/B)
2. Form MD – 7 (For Indian manufacturers – Class C/D)
3. Form MD-14 (Importers)

• Pay the Government Fee – Pay the required fee as per the device’s class and license type.
• Application Review by CDSCO – Now, here, CDSCO will review the application, check documents, and may ask for clarification.
• Grant of License – If everything is correct, CDSCO will issue the registration:

1. MD – 5 for domestic manufacturing 
2. MD – 15 for imports
3. MD – 9 for manufacturing of Class C & D products

What Documents are Required for SKD Registration for Medical Device Accessories?

If you want to apply for SKD registration for medical device accessories, you must have all these documents:

For Indian Manufacturers (Form MD-3 or MD-7)

• Covering Letter
• Duly Filled Application Form (MD-3 for Class A/B or MD-7 for Class C/D)
• Manufacturing License (if already available)
• Device Master File (DMF)
• Plant Master File (PMF)
• Details of SKD Components and Assembly Process
• List of Medical Devices to be Assembled
• Technical File and Product Description
• Product Labels, Artworks, and Packaging Samples
• Quality Management System Certificate (ISO 13485)
• Undertaking of Conformity to Indian Standards
• Copy of Test Reports/Performance Data
• Details of Manufacturing Site
• Details of Technical and Quality Staff
• Site Plan and Utility Information
• Risk Management File (As per ISO 14971)
• Instruction for Use (IFU/User Manual)
• Declaration of Class and Intended Use
• Valid Factory License

For Importers (Form MD-14)

• Covering Letter
• Duly Filled Form MD – 14 
• Power of Attorney/Authorization Letter from Foreign Manufacturer
• Importer’s IEC Code
• Free Sale Certificate or CE/FDA Approval
• Product Description and SKD Components Details
• Device Master File (DMF)
• Plant Master File (PMF) of Foreign Manufacturing Site
• Test Reports and Clinical Evaluation Data
• Labeling, Artwork, and Packaging Samples
• ISO 13485 Certificate of Manufacturing Site
• Instruction for Use 
• Declaration of Conformity to Indian Standards
• Details of the Indian Authorized Agent
• Agreement between Importer and Foreign Manufacturer
• List of Devices and Intended Use
• Risk Assessment and Safety Report

Can ELT Corporate Help With SKD Registration for Medical Device Accessories?

ELT Corporate is one of the best regulatory consultancies in India and can help you with complete support for SKD registration for medical device accessories. From documentation to CDSCO approval, our experts ensure a smooth, fast, and compliant process.

• Expert in SKD Registration for Medical Devices
• Complete Support from Classification to License Grant
• Help in Preparing Technical Documents, DMF, PMF, IFU
• Assistance in Appointing Authorized Indian Agent (AIA)
• Guidance on CDSCO SUGAM Portal Application (MD-14/MD-5)
• 2500+ Successful Client Registrations Across India
• Help with Labeling, Compliance & Post License Support