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- Regulatory Oversight: Regarding safety, quality, and performance compliance on medical devices, cybersecurity concerns are also relevant in CDSCO.
- Risk Control: The manufacturers should address the risks associated with the cybersecurity of the device during the whole life cycle, starting from the stage of development and even after the release of the device to the market.
- Security by Design & Controls: This will prevent breaches, which mean proper software designs with appropriate control and authentications should be designed for medical devices.
- Post-market surveillance: The expectations from the post-market surveillance process in respect to cybersecurity concerns, such as incident reporting, and actions taken for their resolution through post-market patches and/or software updates.
- Documentation & Compliance: Documentation of those various regulatory issues needs to be performed regarding information related to cybersecurity threats, software patches, and risk control mechanisms.
Introduction
The Central Drugs Standard Control Organisation has mentioned the Medical Devices requirements for medical devices with respect to patient safety, data protection, and reliable device performance. In addition, as medical devices are increasingly reliant on software, connectivity, and digital interfaces, they also are increasingly vulnerable to cyber threats that could impact functionality and confidentiality. CDSCO expects medical device manufacturers to implement cybersecurity risk management across the entire lifecycle of the product-design, development, and throughout post-market surveillance-aligned with India’s medical device regulatory framework.
What is CDSCO License?
CDSCO License is a legal recognition that has been ratified and authorized by the Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare, Government of India. Essentially, this is a mandatory license that all concerned organizations need to have for the manufacturing, importation, distribution, sale, and/or clinical investigation of all new drugs, cosmetics, and Medical Devices for sale in India. This particular license issued by the CDSCO is primarily used to ensure that all products that are issued with this license meet all the required standards for it to be considered as safe, good, and effective products, as noted by the Drugs and Cosmetics Act passed in 1940. It involves the submission of technical dossiers and regulation of Good Manufacturing Practices.
Key Points:
- It is obligatory for regulated products such as drugs, medical devices, cosmetics, and vaccines.
- This license will ensure quality, safety, and efficacy in accordance with Drugs & Cosmetics Act & Rules.
- Licenses for manufacturing a product, importation of a product, clinical trials of a product, or marketing a product vary.
- CDSCO operates together with State Drug Control Authorities for inspection and enforcement.
- Without a license from CDSCO, products cannot be marketed or distributed in India.
Why is CDSCO Certification Mandatory
CDSCO Certification is a mandatory governmental approval in India that secures approved standards of safety, quality, and performance of drugs, medical devices, as well as cosmetic items. It is a Government of India approval that is extremely necessary for the manufacture, import, sale, or distribution of specific items. With this approval, it becomes possible to safeguard public health, which would otherwise suffer due to the distribution of sub-standard or harmful items, as implementing approval ensures that there are no defaults under the Drugs & Cosmetics Act.
Key Reasons:
- “Ensures safety, quality, and efficacy of medicines, medical devices, and cosmetics made available in the Indian market.”
- “Required for the manufacture, importation, distribution, and sale of the product under the “Drugs and Cosmetics Act of 1940”.
- Helps secure public health by safeguarding against the use of below-standard, unsafe, or fake drugs.
- Guarantees compliance to the regulatory requirements, GMP, as well as quality controls as required by the Central Drugs Standard Control Organisation.
- Helps in regulatory approval, surveillance, and recall processes for monitoring the safety of goods.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| It is responsible for protecting the health of the people through ensuring that only safe and effective products are available. | Boosts credibility and consumer trust, as well as regulatory and healthcare professional trust |
| Provides the legal right to manufacture, import, and sell regulated products in India. | It assists in entering easily into the market. It also assists in easy distribution within the Indian market. |
| It is also accountable for ensuring that it falls within the scope of the Drugs & Cosmetics Act of 1940. | It reduces the risk of legal punishment, recall, and ban. |
| Assures quality and safety standards. | Adds to product acceptance and competitiveness within the domestic and foreign markets. |
| Support to pharmacovigilance, post marketing surveillance, and safety surveillance for the Central Drugs Standard Control Organization. | It maintains quality and safety and helps adhere to regulatory compliance. |
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 a reliable regulatory consultant for businesses to successfully address complicated regulatory requirements of the medical device, pharmaceutical, cosmetic, or food industries, among others. Selecting Diligence Certifications will help you get products with the required standards like CDSCO, CE, FDA, ISO, or other regulatory requirements at the national or international levels.With experienced regulatory professionals in their team, Diligence Certifications offers full support, ranging from document to submission, risk management, audit, and others. This is combined with their knowledge in the regulatory process that makes their services more client-oriented, thus getting fast approvals and minimizing risks in addition to gaining credibility for the products.
Conclusion
It is important to point out that regulatory compliance is the key to product safety, quality, and compliance in regulated sectors that have compliance from various regulatory authorities. In this regard, identification and procurement of the best solution for certification and regulatory compliance could help streamline difficult regulatory rules and procedures that could, in turn, help minimize risks associated with regulatory compliance.
Frequently Asked Questions (FAQs)
Definition of CDSCO
The Central Drugs Standard Control Organisation is the regulatory body. It is responsible for drug, device, and cosmetic regulations in the Indian market.
Is it required within the Indian context?
Yes, manufacture, import, sale, and distribution of the regulated product are compulsorily required to be made within India.
What products need approval from CDSCO?
In India, the different medicines, devices, IVD devices, cosmetics, and vaccines manufactured have to get approval from CDSCO.
What is a CDSCO?
"It is a legal permit that gives companies a marketing authorisation for regulated products within India."
Are the requirements for cybersecurity relevant to medical devices?
True, it is expected by the CDSCO that cybersecurity risk management should continue throughout the life of medical devices.
Give a brief description of what security by design refers to.
It implies that cybersecurity should be integrated during design and development.
Is post-market surveillance mandatory?
Indeed, it is necessary to monitor safety, performance, and cybersecurity cases post-market.
How much time does it take for the certification at CDSCO?
It usually takes 20–30 working days according to the product type and the resolution of the query.
What is the validity of a license issued by CDSCO?
Generally up to 2 years - subject to the regulatory conditions and renewal on time.
Can certification by CDSCO be renewed?
Yes, it is to be applied for before expiration with updated documents and applicable fees.
