How to Get Medical Device Certification in India? CDSCO Approval Process Explained

Technologically sophisticated and clinically relevant products are not enough to make it to the Indian market, as the market is governed by a myriad of processes. Before producing or importing a medical device for legal marketing in India, all manufacturers and importers must determine the device’s classification, licensing path, technical documentation, and testing requirements.

Medical Devices Rules, 2017, regulate medical devices in India through the Central Drugs Standard Control Organisation. Medical devices are divided into classes A, B, C, and D by the CDSCO through a risk-based classification system. The path of regulation then depends on the classification of the device and whether it is an Indian-made or imported device.

This does not imply that there is only one medical device certification. This requirement could be in the form of a manufacturing licence, import licence, permission, or another regulatory approval from CDSCO depending on the product and business model. UMSPCS will help you in each step of certification. 

What Is Medical Device Certification in India?

Medical Device Certification is a general term used to describe the regulatory process used by the manufacturer/importer to establish that the medical device fulfils the applicable regulatory and safety requirements in India.

Please note that under MDR 2017, medical devices will be regulated on the basis of risk:

• Class A – Low risk
• Class B – Low-moderate risk
• This is considered high risk, but not severe, and is included under Class C.
• Class D – High risk 

Why Is CDSCO Approval Important for Medical Devices?

Medical devices have a direct impact on patient diagnosis, treatment, monitoring, or safety. Regulatory oversight thus serves as a barometer for ensuring that devices available in the market comply with the applicable safety and performance criteria.

In the case of manufacturers/importers, the relevant CDSCO approval/licence may assist:

• Comply with Indian regulations.
• Ensure compliance with relevant safety and performance standards.
• Facilitate legal market access.
• Boost the trust of hospitals, distributors and healthcare professionals.
• Have a regulated quality and regulatory procedure.
• Promote commercial supply of regulated devices in India.

CDSCO advises on key principles for the safety and performance of medical devices, as well as classification, grouping, and MDR 2017 regulatory pathways. 

Who Needs CDSCO Approval for Medical Devices?

The regulatory requirements may be applicable to:

Indian Manufacturers

Every manufacturer who wants to manufacture a regulated medical device in India must get a manufacturing licence or permission for the class of device to be manufactured.

Foreign Manufacturers

Usually, foreign manufacturers plan to bring in regulated medical devices into India by means of an Indian authorised agent for the particular import-licensing procedure.

Importers

The importer has to adhere to the import licensing requirements of the CDSCO for the regulated medical device.

OEM and Contract Manufacturing Businesses

Where third parties are involved in manufacturing or marketing medical devices, they need to consider who is responsible for the appropriate licence and what information will need to be provided in the regulatory application.

The correct route will vary depending on the product, risk class, manufacturing site, and the activity planned in the regulatory process.

Where Do Manufacturers Apply for Medical Device Approval?

CDSCO has set up an online regulatory system for medical devices, which has a medical-device online portal for applications, tracking, and related regulatory functions. The current official medical-device portal offers facilities for risk classification requests, applications, information about approved devices, and regulatory guidance.

For example, CDSCO Medical Device Certification identifies the following key application routes:

• MD-14 → MD-15 for import licensing of medical devices.
• MD-7 → MD-9 for manufacturing Class C and Class D devices.
• MD-3 to MD-5 for production of Class A devices via the State Licensing Authority route.

Other forms apply for testing, clinical investigations, and specific new-device pathways. 

When Is CDSCO Approval Required?

Before undertaking the regulated commercial activity (e.g., manufacturing for sale/distribution or blxhzltzdlne, va lwjexdlcp a regulated medical device for commercial supply), the applicable CDSCO licence or permission should be obtained.

Therefore, businesses need to start regulatory assessment early in the business’s development process, before the device is in the market.

Early assessment allows the manufacturer to determine:

• Risk classification.
• Applicable licence.
• Testing requirements.
• Technical documentation.
• Quality-management requirements.
• If applicable, clinical or performance evidence.
• Labelling requirements.
• Import and/or manufacturing duties.

CDSCO’s official guidance confirms that classification is based on risk parameters specified in the First Schedule of MDR 2017. 

Why Do Some Medical Device Applications Get Delayed?

The path to the market can take a long time if the regulatory route is not selected accurately from the outset for medical device applications.

Common reasons include:

• Incorrect device classification.
• Incomplete technical documentation.
• Incorrect product grouping.
• Missing risk-management documentation.
• Inadequate test reports.
• Inconsistent product information.
• Lack of labelling and IFU information.
• Lack of quality-management records and documentation.
• Failure to include clinical or performance evidence when necessary.
• Slow response to queries from CDSCO.

CDSCO has prepared official guidelines on device grouping, classification, and application checklists, which make a point of the necessity of submitting proper technical data for the pathway chosen. 

Complete CDSCO Approval Process for Medical Devices

Medical Device Registration under CDSCO to obtain the certification is subject to different regulations. It will be helpful for the manufacturer and importer to have knowledge about this process, as it will save their time.

Step 1: Device Classification

To apply for the CDSCO registration of your medical devices, you should first classify the device as per the CDSCO standards.

Important Activities:

• Determining the use of your product.
• Classifying the product as per the CDSCO standards.
• Regulatory requirements checking.

Step 2: Preparing Documentation

Preparing documentation in accordance with the technical, regulatory, and quality issues of your pain management devices.

Important Activities:

• Technical and safety documentation preparation.
• Preparation of Device Master File and Plant Master File.
• Preparation of quality certificates and other required documents.

Step 3: Completing the Application Form

Complete the CDSCO application form according to the product and the manufacturer.

Important Activities:

• Completing the CDSCO application form.
• Verification of all the information/documents.
• Reviewing the application.

Step 4: Submitting the Application online

The duly filled application form, along with the relevant documents and fee as prescribed by the government, must be submitted through the CDSCO online portal.

Activities Associated:

• Submitting the application and the documents.
• Payment of government fee.
• Submitting the application online.

Step 5: Evaluation and Inspection by CDSCO

Evaluation will be done by the CDSCO with regard to the submitted application as well as verification of the relevant documents. The manufacturing unit can also be inspected whenever required.

Activities Associated:

• Answering the queries of CDSCO.
• Providing additional information, if needed.
• Inspection, if needed.

Step 6: Approval and License

After successful evaluation of the application form by the CDSCO, approval for issuing the relevant licence will be issued, which will enable the manufacture/import of the medical device in India.

• Activities Associated:
• Getting the CDSCO approval.
• Issue of licence.
• Manufacture/import of the device in accordance with CDSCO standards.

Documents Required for CDSCO Medical Device Certification 

Preparation of accurate documentation is among the most important aspects when working towards obtaining the CDSCO Medical Device Certification. Any omission in information, errors in formatting, or any inconsistency in the technical document will subject an application to investigation, delay, or denial of the request.

The documents may differ according to whether the applicant is applying for a:

Manufacturing licence:

• Letter of covering
• Constitution of company
• Proof of ownership of premises
• Plant master file
• Device master file
• Essential principles checklist
• Risk management file
• ISO 13485 (quality management system)
• Inspection/Audit report
• Challan of payment
• Premise layout
• Test licence on Form MD13

Import licence:

• Letter of covering
• Notarised power of attorney either apostilled or issued by the first-class magistrate of India
• Constitution of company
• Proof of ownership of premises
• Plant master file
• Device master file of the foreign manufacturer
• A free sale certificate in the country of origin is required. This will confirm that the product is legally sold and marketed in the country of origin.
• Essential principles checklist
• Risk management file
• ISO 13485 (quality management system)
• Challan of payment

How Can UMSPCS Help With Medical Device Certification?

Medical device compliance can be tricky when manufacturers are not aware of India’s risk-based regulatory approach.

UMSPCS can assist with:

• Product applicability assessment.
• Risk-classification support.
• Regulatory pathway identification.
• Technical documentation.
• Testing coordination.
• Application preparation.
• SUGAM portal support.
• CDSCO query handling.
• Import/manufacturing licensing assistance.
• Post-approval compliance guidance.

UMSPCS has successfully completed over 600+ product compliance projects with over 6 years of experience, helping manufacturers and importers to approach CDSCO medical-device compliance in a structured way. Also, get to know more information about the CDSCO Cosmetic License in India.

Conclusion

There is no medical device certificate for approval; India’s regulatory approval is based on a risk-based process. Based on the device’s risk class, manufacturing/import arrangement, and intended regulatory activity, the applicable licensing pathway is as follows under MDR 2017: Class A, Class B, Class C, and Class D. 

In the business context, it is best to identify the proper classification and regulatory pathway prior to the preparation of testing and technical documentation. With proper planning, the need for unnecessary queries can be minimised, and the production process through CDSCO can be streamlined. 

Read more also: Why BIS Certification Matters for Office Furniture Manufacturers

FAQs 

• Is CDSCO approval necessary for medical devices in India?

CDSCO or licensing authority approval is mandatory for regulated medical devices prior to commercial manufacture/import based on the particular pathway.

• How are medical devices categorized in India?

According to MDR 2017, medical devices are classified into four classes. A, B, C, and D.

• What is the application form for the import of classified medical devices?

For the import of classified medical devices, the application form is MD-14 with the licence form MD-15.

• Who is the issuing authority for licenses to manufacture Class C & D medical devices?

The Central Licensing Authority handles applications for licences to manufacture Class C and Class D medical devices.

• Is clinical evidence necessary for all medical devices?

Clinical evidence is not necessary for all medical devices, depending on the device and its classification.

6. How will UMSPCS assist with medical device approval?

UMSPCS will assist with classification, documentation, testing, the application process, CDSCO queries, and post-approval compliance.