What You Need to Know About CDSCO's Medical Device Regulations?

What is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) has worked to simplify medical device regulations throughout recent years to enhance safety measures and improve product quality. To guarantee openness, consistency and accountability in the caliber and standards of medical items imported, produced and marketed in India, CDSCO is always introducing new updates. For producers and importers looking to join the Indian market, it is essential to comprehend these standards, the filing procedure and its deadlines.

CDSCO Medical Device Registration Classes

The Central Drugs Standard Control Organization (CDSCO), like various other national regulators, classifies medical devices into four categories based on risk:

• Class A (low risk)
• Class B (low-moderate risk)
• Class C (moderate-high risk)
• Class D (high risk)

The classification determines the regulatory requirements and the documentation you'll need to assemble for entry to the Indian market.

Submission Timelines for CDSCO Medical Devices

The class of your medical device and the level of review complexity determine how long it takes to submit and get approved.

• Class A and B devices
  • After the submission date, the review procedure normally takes three to six months.
  • If necessary, inspections might add another one to two months to the timeframe.
• Class C and D devices
  • Because of the extensive technical inspection required, the review procedure may take six to twelve months.
  • The schedule may be further extended by two to three months for inspections and TAC consultations.

Who Needs to Get a CDSCO Registration?

Various applicants dealing with medical devices must apply for CDSCO registration online:

• Importers
• Manufacturers
• Indian Agents
• Distributors
• Corporates
• Foreign Enterprises holding Indian Subsidiary

CDSCO Medical Device Registration Process

The steps of the CDSCO registration process:

• Application submission
  • For new devices, manufacturers/importers must submit an application in Form MD-14 (for Class A/B) or Form MD-15 (for Class C/D) via the online Sugam portal.
  • Required documents, including the DMF, PMF, clinical data and QMS certification, must be sent with the application.
• Review and scrutiny
  • The supplied documents are examined by CDSCO to ensure they are comprehensive and meet all legal criteria.
  • A thorough technical review is carried out for Class C and D devices, which may entail discussions with the Technical Advisory Committee (TAC) and subject matter experts.
• Inspection and verification
  • To ensure adherence to QMS and Good Manufacturing Practices (GMP), CDSCO may inspect manufacturing facilities.
  • For imported equipment, CDSCO may depend on inspection reports from other accredited regulatory bodies or conduct inspections at overseas manufacturing facilities.
• Approval and licensing
  • After proper review and inspection, CDSCO issues the registration certificate and import/manufacturing license in Form MD-5 (for Class A/B) or Form MD-6 (for Class C/D).
  • The license must be renewed after its five-year expiration date.

Why Obtain a CDSCO Registration?

The CDSCO license acts as legal support for the drug business. It increases the reliability and trust of the customers. Here are some of the benefits of why a drug business needs CDSCO registration for its medical product/device or cosmetics product:

• Wider Opportunity: To enhance the brand image and attract a wider opportunity in national and international markets.
• Legal Advantage: Following medical device regulations enables manufacturers to easily create medical devices for sale and distribution in India. By avoiding government notifications, fines, etc., the CDSCO license offers legal advantages.
• Safety: The quality assurance system of medical products through safety and security measures minimizes both legal penalties and potential risks.

Conclusion

The regulatory process for medical devices in India demands complete preparation along with a proper understanding of CDSCO requirements. Manufacturers and importers who comply with the medical device regulations of CDSCO can access the rapidly expanding medical device market in India. The Om Garuda team assists in ensuring compliance with your documentation, QMS and labeling standards by following the structured submission process. We offer comprehensive assistance throughout the entire CDSCO Medical Device Certification process, keeping track of timelines to help in strategic planning and efficient market entry.