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- For the approval of the manufacture, import, or sale of the CDSCO Registration Diagnostic Kits in India, an application has to be filed with the Central Drugs Standard Control Organization (CDSCO).
- Additionally, the diagnostic kit products have to be categorized as IVD Medical Devices as governed by the Medical Device Rules, 2017.
- Things that must be submitted with the application for the CDSCO’s approval are: technical documentation (device information), performance analysis and a list of potential risks assigned to them.
- The Quality System requirements that must be met, i.e., ISO 13485, as well as labeling requirements for diagnostic kits.
- CDSCO Registration Diagnostic Kits are supported by safety, accuracy, and officially accepted in the Indian Market.
Introduction
Registration of CDSCO Registration Diagnostic Kits by the Central Drug Standard Control Organization (CDSCO) is a statutory requirement for the indian government to ensure the safety, quality, and performance of In Vitro Diagnostic devices. Being regulated by the Central Drug Standard Control Organization under the Medical Device Rules, 2017, this registration is a requirement for manufacturers/importers prior to the sale of diagnostic kits available in the indian market.
What is CDSCO License?
A CDSCO License is a legal authorization issued by the Central Drugs Standard Control Organization, CDSCO, that enables persons who intend to manufacture or import drugs, devices, or diagnostic kits in India. It is issued to those who are in compliance with the Drugs & Cosmetics Act, 1940, as well as the Medical Device Rule, 2017, offering an assurance that the products meet the predefined requirements regarding safety, quality, or performance prior to their distribution in the market.
Key Points:
- This guideline has been published by a government organization named Central Drugs Standard Control Organization (CDSCO) for controlling Indian drugs, devices, and diagnostic kits.
- Required in the case of the manufacturing, import, sale, or distribution of controlled healthcare products.
- Compliant to the Drugs & Cosmetics Act, 1940 & Medical Device Rule, 2017.
- Ensures the conformation of the products to the standard of security, quality, and performance.
- Improves legal market access, increases trust with regulators and consumers.
Why is CDSCO Certification Mandatory
The selling of drugs, medical devices, and CDSCO Registration Diagnostic Kits in India requires certification by CDSCO to meet the prescribed standards concerning safety, quality, and performance. The Central Drugs Standard Control Organization takes this right and responsibility upon itself for the protection of public health, preventing sale of spurious lots, ensuring regulatory compliance in accordance with the laws of the land, and legal market access throughout the country.
Key Reasons:
- Provides safety, quality, and performance assurance for drugs, medical devices, and diagnostic kits. It is also regulated by Indian law, which is governed by the Central Drugs Standard Control Organization or CDSCO.
- It is also mandated by Indian law and regulated under the Central Drugs Standard Control Organization or CDSCO.
- Prevents the making and selling of low-quality or unsafe products.
- Ensures the protection of public health and the safety of patients throughout India.
- Enables legal market entry and nationwide distribution of controlled products.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| Mandatory regulatory requirement for drugs, devices, and diagnostic kits in India. | Grants legal authority for the manufacture, importation, and sale of Indian goods. |
| Comply with Indian regulations & Medical Device Regulations, 2017. | Ensures that the healthcare goods are safe, effective, and of good quality. |
| Regulated by “Central Drugs Standard Control Organization” (CDSCO). | Builds confidence between healthcare providers and consumers. |
| Guarantees public health through its control over product quality and safety. | Avoids the risk of fines from the relevant authorities, seizure of the merchandise at the customs office, and disruptions of business. |
| It also prohibits the sale of unsafe, sub-standard, or unapproved goods. | Enables business growth and an smooth entry into the Indian healthcare market. |
Step-by-Step Process of CDSCO Certification
Step1:Documentation
- Define product category (drug, medical device, cosmetic, IVD)
- Technical dossier and product information preparation
- Obtain company registration documents and manufacturing/import licenses
- Compliance with CDSCO documentation requirements
Step2:Product Testing
- Send product samples to NABL-accredited/BIS-recognized
- Perform safety, performance, and quality tests
- Collect valid test reports
- Ensure adherence to CDSCO requirements
Step3:Application Submission
- Register yourself on the CDSCO SUGAM portal
- Submissions of Applications by CDSCO
- As mentioned in various
- All necessary documents and test reports have been uploaded
- Pay the mandated CDSCO government fees
Step4:Scrutiny and Inspection
- CDSCO evaluates submitted documentation
- Technical assessment: Product details
- Manufacturing site inspection can be performed
- Queries/ Clarifications raised, if any
Step5:Grant of License
- Application approved by Central Drugs Standard Control Organization
- CDSCO License / Registration Certificate issued
- Approved product for manufacturing/import and sale in India
- Validity of the license renewable as per regulatory terms
Documents Required for CDSCO Certification
| Category | Documents Required |
| Business Documents | Business license/registration, ISO certificate, organizational details |
| Manufacturer Details | Factory layout, process flow chart, machinery list, production details |
| Product Documents | Product specifications, component list, user manual, model details |
| Testing Documents | Test report from BIS-recognized lab, sample details, test request form |
| Legal & Compliance | Authorization letter, brand ownership proof, trademark certificate (if any) |
| Import/Foreign Manufacturer (If applicable) | AIR (Authorized Indian Representative) details, contract agreement, overseas manufacturer documents |
Timelines, Costs, Validity & Renewal
- Timelines: Processing of CDSCO certification typically consumes 20-30 working days, of which 7-15 days are required for product testing, subject to the nature of the product and resolution of inquiries.
- Expenses: Fees charged by the government differ according to product types, whether it be a drug, medical device, cosmetic, or import product. Other costs can also be incurred depending on inspection, retesting, or changing documentation.
- Validity:In most cases, a CDSCO license/registration certificate is issued with a validity period of 2 years, depending on several regulatory conditions.
- Renewal: The process of renewing a license has to be carried out before its expiry date to prevent a suspension or lapse in the license.
- Renewal Requirements:A set of updated documents, formatted test reports (if needed), and the payment of predetermined fees are the necessities for successful renewal under the Central Drugs Standard Control Organization.
Why Choose Diligence Certifications
Diligence Certifications is one of the foremost regulatory compliance consultancies in India, involved in assisting completely with CDSCO, BIS, and all other mandatory certifications. Having a team of talented experts with accurate documentation and a streamlined approach, Diligence Certifications can assist manufacturers and importers in obtaining faster approvals and achieving hassle-free entry in the market with regulatory compliance.
Conclusion
CDSCO Certification is very crucial in a country like India for ensuring that medications, healthcare products like devices, and diagnostic kits adhere to certain safety and quality standards. It protects consumers from any harm and also helps in easy market entry in India. CDSCO Certification is very prudent in protecting healthcare stakeholders from government-related risks in India. CDSCO Certification also assists in increasing credibility in the healthcare industry.
Frequently Asked Questions (FAQs)
What is CDSCO?
Central Drugs Standard Control Organization is the national authority for regulation related to drugs, medical devices, and diagnostic kits in India.
Is CDSCO registration required for diagnostic kits?
CDSCO Registration is indeed necessary if one intends to produce, import, or market clinical kits in India.
Under which law are diagnostic kits regulated?
Diagnostic kits are controlled by the Medical Device Rules, 2017, as well as the Drugs & Cosmetics Act, 1940.
Are diagnostic kits classified as Medical Devices?
Yes, diagnostic kits are In Vitro Diagnostic (IVD) devices.
In Vitro Diagnostic (IVD) devices
Who needs to apply for CDSCO registration?
All applications must be made by the manufacturers, importers, and Authorized Indian Representatives.
What are the documents for CDSCO approval?
Technical files, test reports, ISO 13485 certificates, labeling information, and legal documentation are also required.
Is ISO 13485 applicable for diagnostic kits?
"ISO 13485 compliance is necessary in order to fulfill quality system requirements."
What is the time taken for CDSCO registration?
It normally takes 20 to 30 working days. It depends on the type of products as well as the resolution of queries.
How long is the CDSCO license valid for?
The general license issued to CDSCO is only valid for a period of 2 years.
Can a CDSCO Registration be Renewed?
Yes, it has to be renewed before it expires along with fresh documents and fees.
