Why Medical Equipment Manufacturers Need CDSCO Certification?

Demonstrating the efficacy and safety of drugs and other pharmaceutical products is essential before being approved for manufacturing and marketing in the country. The CDSCO Licensing For Healthcare Products ensures that medical devices and medicines are manufactured following regulatory guidelines and passed through stringent safety and quality checks.

CDSCO, operating under the Drugs Controller General of India (DCGI) is the central licencing authority for medical devices. As per the Medical Devices Rules 2017, all medical devices that are imported or manufactured in the country require a licence, except for class A which includes non-measuring and non-sterile medical devices.

Let’s take a brief look at what is a medical device, its classes, and why manufacturers must obtain the CDSCO (Central Drugs Standard Control Organization) authorization.

What is a Medical Device as per the Relevant Laws?

The Drugs and Cosmetic Act 1940 and the Medical Devices Rules 2017 lays down legal guidelines for the regulation of medical devices in India. Medical devices are instruments, appliances, apparatus, materials, implants, or any other article that is used either alone or in combination for the following reasons:

• Diagnosis, treatment, prevention, monitoring or alleviation of any disorder or disease.
• Diagnosis, treatment, monitoring, assistance or alleviation of any injury or disability.
• Modification, investigation, replacement or support of a physiological process or the anatomy.
• Sustaining or supporting life.
• Control of conception.
• Disinfection of medical devices.

What are the Different Classes of Medical Devices?

If a medical device is going to be manufactured, sold, or imported in India, the device requires approval from CDSCO. The national regulatory authority classifies medical devices into four different categories depending on the level of risk they pose to the users and patients.

• Class A: The class includes low-risk medical devices such as absorbent cotton wools, alcohol swabs, surgical gloves, bandages, stethoscopes, and other basic medical instruments. Such devices or components cause minimal to no harm to patients and users.
• Class B: Includes low to moderate-risk medical devices like BP monitoring devices, nebulizers, thermometers, wheelchairs, disinfectants, hypodermic needles, and syringes.
• Class C: The class comprises moderate to high-risk devices that can inflict serious harm to patients if they malfunction and include bone fixation plates, implants, X-ray machines, artificial heart valves, catheters, etc.
• Class D: These medical devices go through stringent checks and stricter regulations owing to their highly risky nature. The class includes ventilators, implanted pacemakers, artificial joints, and heart or lung machines.

Why CDSCO Medical Device Registration is Important?

CDSCO Licensing For Healthcare Products, especially medical equipment is extremely important for the safety of public health. Medical devices that receive CDSCO authorization demonstrate that they meet the rigorous standards for efficacy, quality and safety. Thus, it is crucial to examine these devices to protect patients, healthcare professionals, and the community from harm caused by defective or poorly designed medical devices.

For this, CDSCO conducts a detailed technical review of class C and D medical devices owing to the risk they pose to patients and users. The authorities consult with a technical advisory committee and subject matter experts to get greater insights into the intricacies of the device and assess whether it is safe to use or not. For this, the organization also inspect manufacturing facilities to examine whether the unit is complying with QMS and GMP.

Difference Between CLA and SLA: Medical Device

Concerning medical devices, CLA (Central Licensing Authority) and SLA (State Licencing Authority) are two authorities responsible for granting CDSCO Licensing For Healthcare Products, particularly medical devices.

Central Licencing Authority (CLA): To apply for class C and D medical devices, an applicant has to approach the Central Licencing Authority (CLA). This way, one can obtain a valid manufacturing licence for the distribution and sale of medical devices in India.

CLA enforces rules related to the import of all classes of medical devices and the manufacturing of class C and D devices. The authority also approves devices that do not have predicate devices and clinical investigation. It also registers laboratories to carry out evaluations, test, and classify medical devices based on their risk parameter. CLA register notified bodies and test licences for manufacturing.

State Licencing Authority (SLA): Similarly, for class A and B medical devices, an applicant can receive a valid manufacturing licence under the Medical Devices Rule 2017 by making an application to the State Licencing Authority (SLA). As far as SLA is concerned, the authority also manages rules related to manufacturing for sale or distribution of medical devices of class A or B. It also enforces guidelines related to stock, sale, exhibit or distribution of all classes of medical devices.

Certain Common CDSCO Registration Challenges and Solutions arise related to medical device authorization. One of the major challenges is the complex regulatory procedure which is considered lengthy and time-consuming. Keep reading to get a detailed overview regarding which form to fill out and attest which documents to successfully obtain your authorization.

Regulatory Pathway for CDSCO Medical Device Registration

Under the Medical Device Rules 2017, the regulatory pathway that needs to be followed for medical devices, commencing from development to commercialisation is as follows:

• MD 12: Application to obtain a test licence using this form. Test licence enable controlled testing of new devices before being fully released into the market.
• MD 13: Provide a licence to manufacture small quantities of medical devices for evaluation, testing, and clinical research.
• MD 16: Application to obtain authorization to import medical devices for evaluation and testing.
• MD 17: Approval/ licence issued by CDSCO to import devices for testing and not for immediate sale in the market.

Manufacturing licence for commercialization issued by SLA for Class A and Class B Medical devices are:

• MD 5: Grant permission to manufacture or produce Class A and B medical devices in India.
• MD 6: Used to apply for a loan licence that permits the manufacturer to produce devices on a borrowed facility.

Manufacturing licences for commercialization issued by CLA for Class C and D are mentioned below.

• MD 9: Allow manufacturers to produce and sell medical devices of class C and D.
• MD 10: Provide ‘loan licence’ to produce class C and D medical devices on borrowed facility.

Import licence issues by CLA for all classes of medical devices require an application to obtain a licence using the following form:

• MD 15: Permit applicant to import medical devices of all classes.

Navigating the complex regulatory landscape of medical devices is important to obtain CDSCO authorization. For this, compile the Essential Documents Checklist for CDSCO Registration, follow the labelling requirements, and provide complete and accurate information to quickly gain access to the growing medical device market in India.

Documents Required to Register Medical Devices

Manufacturers of Medical Devices need to furnish the following documents for CDSCO Licence:

• Name and Address of the firm or company or any other entity manufacturing such device.
• Details of a Medical Device must include its generic name, model number, intended use, class of medical device, material of construction, whether it is sterile or non-sterile, dimension, shelf life, and brand name.
• Certificate of compliance with regards to ISO 13485 standard, which is accredited by the National Accreditation Board for International Accreditation Forum or Certification Bodies.
• Undertaking duly signed by the manufacturer highlighting that information provided by the applicant is authentic.

Apart from this, an applicant must provide a set of key risk and quality documents to help authorities verify the efficacy and safety of medical devices. These are:

• Device Master Plan (DMF): A DMF contains data related to components, materials, and manufacturing processes. Since the data can vary depending on the type of component or product, CDSCO has not prescribed a specific format for it.
• Plant Master File: PMF provides information regarding the plant layout specifying production, quality control, storage, and packaging details. PMF must provide a detailed inventory of all the equipment used in quality control and manufacturing.
• Free Sale Certificate: The State Licencing Authority issues FSC (Free Sale Certificate) which is essential for medical device manufacturers who wish to cater for the international market. The certification demonstrates that the product is safe to use and non-hazardous.
• BIS Certification: Certain medical devices are required to comply with standards set by BIS (Bureau of Indian Standards). Check whether your device falls on this list and obtain its certification to proceed with the application process.
• Labelling: The medical device must be labelled as per the instructions mandated in MDR 2017 including information such as batch number, manufacturer details, and expiry date.

Which Products Are Authorized by the CDSCO?

CDSCO Licensing For Healthcare Products includes the following products:

• Drugs: CDSCO has extensive regulatory control over the approval of new drugs, import of drugs and clinical trials. The regulatory authority categorizes new drugs into sub-categories namely new drugs substances, investigational new drugs, additional indication, additional strength, etc. CDSCO obtain information regarding dosage form, composition, manufacturing formula, quality control checks, and finished product specification to ensure proper disclosure of its specifications and regulation of drugs before being marketed and sold.
• Medical Devices: The national regulatory authority regulates the registration and sale of medical devices in India. The devices are categorized into Notified and Non-Notified. It is mandatory to register notified medical devices as per the provision of Rule 4, MDR 2017. However, non-notified devices can be voluntarily registered with CLA and include devices like adhesive drapes, gowns, etc.
• Cosmetics: CDSCO regulates a wide range of cosmetic items that are meant to be rubbed, sprinkled, poured, sprayed on, or applied to the human body. To import cosmetics in India, the applicant has to register the cosmetic product as well as the manufacturing site.
• Biologicals: Biologicals include allergenic extracts, blood products, human cells and tissues, gene therapies, and vaccines. In India, these products are considered new drugs and require approval from CDSCO. The authority grants permission for marketing and manufacturing, clinical trials, authorizes import of drugs from R&D, and ensures compliance with GMP standards.

Final Thoughts

The Ministry of Health and Family Welfare notified the Medial Device Rules 2017 that came into effect on January 1st, 2018. With the issuance of the rule, CLA and SLA were delegated the responsibility to provide licences to manufacturers, distributors, and importers of medical devices. To obtain CDSCO authorization, the applicant has to submit the relevant form along with the requested documents and disclosures. The authority, as per the class, will conduct an audit or inspection to scrutinize the submitted information.

Our expert professionals are here to inform and simplify every aspect of CDSCO registration for medical devices. Legal Raasta will assist you in finding out which class your category falls into and how we can synergize our efforts to enhance compliance. Our team will verify your application and other relevant details and coordinate with concerned authorities for follow-ups. Over the years, we have served over 15,000+ clients and provided CDSCO Licensing For Healthcare Products seamlessly and cost-effectively.