Medical Devices
Under regulatory oversight from bodies like the CDSCO, devices for diagnosing, treating, or preventing diseases undergo thorough scrutiny. At Hospiraa, we prioritize adherence to these standards, ensuring meticulous compliance, upholding top-tier quality and safety measures, and facilitating seamless regulatory processes for our clients.
Here’s an in-depth look at the documents required and our streamlined timeline for processing:
Timeline: 15 Days – From submission to approval, ensuring minimal delays.
Documents Required
- Covering Letter: Clearly stating your intentions and needs.
- Application Form No.41: Essential for formal application submission.
- Challan of Rs.3500: Payable to The Director of Drugs Control Chennai.
- Declaration Form: Ensuring transparency and compliance.
- Key Plan (Blueprint): Providing an overview of your premises layout.
- Site Plan (Blueprint): Detailing the specific site arrangements.
- Proof of Ownership or Rental Agreement: Confirming premises legitimacy.
- Proof of Firm’s Constitution (Certified Copy): Such as Partnership Deed.
- Tax Receipt (23-24): Demonstrating financial compliance.
- Registration Certificate of Tamil Nadu Pharmacy Council/Competent Person: Essential for legal operation.
- Bio-data Form for Technical Staff (Manufacturing): Highlighting expertise.
- Competent Person Declaration: Duly attested by Notary.
- Self-Certification of Supplies to Goods Distribution: Ensuring accountability.
- Legal Tenancy Affidavit (100 Stamp Paper): Affirming tenancy legality.
Procedure
Submission
Compile and submit the required documents.
Review
Thorough assessment of documents for completeness.
Processing
Our team works diligently to facilitate the process.
Approval
Upon successful review, expect prompt approval.
HOSPIRAA's Expert Guidance in Certification Acquisition
At HOSPIRAA, we specialize in simplifying the certification process for surgical and medical device agencies, offering:
- Comprehensive Assessment: We assess each agency’s unique requirements to determine the specific certifications needed for compliance.
- Documentation Support: Our expert team assists in preparing thorough documentation, ensuring accuracy and completeness for certification applications.
- Efficient Application Process: HOSPIRAA expedites the submission of certification applications, facilitating a smooth approval process with regulatory authorities.
- Training and Compliance Audits: We conduct training sessions and compliance audits to ensure agencies meet regulatory standards for product handling, storage, and distribution.
- Ongoing Support: HOSPIRAA provides continuous guidance to navigate regulatory changes, ensuring sustained compliance and operational excellence for surgical and medical device agencies.
Licenses for Manufacturing Medical Devices and In-Vitro Diagnostics
In India, the regulation of medical devices is governed by the Drugs and Cosmetics Act, 1940, and its corresponding rules. Currently, only notified medical devices fall under the purview of this regulatory framework, categorized as drugs. These include substances for in vitro diagnosis, surgical items, contraceptives, disinfectants, insecticides, and devices notified under specific clauses of the Act.
Mode: Online
Link: CDSCO Medical Device Diagnostics Portal
Here’s an in-depth look at the license categories and applications, and our streamlined timeline for processing:
Timeline: The overall process takes 45 Days
License Categories and Applications:
Class A and Class B Medical Devices
- Application: MD -1
- License: MD-2
Grant of Import Licence
- Application: MD-14
- License: MD-15
Loan License to Manufacture for Sale
- Application: MD-7 & MD-8
- License: MD-9 & MD-10
License to Import for Test, Evaluation, Clinical Investigations
- Application: MD-16
- License: MD-17
Grant of License to Import Investigational Medical Device
- Application: MD-18
- License: MD-18
Permission to Conduct Clinical Performance Evaluation
- Application: MD-24, MD-25
Import or Manufacture Medical Device without Predicate Device
- Application: MD 26
- License: MD-27
Import or Manufacture New In-Vitro Diagnostic Medical Device
- Application: MD-28
- License: MD-29
Registration of Medical Device Testing Laboratory
- Application: MD-39
- License: MD-40
Sale and Distribute Medical Device
- Application: MD -41
- License: MD-42
The process for obtaining licenses for medical devices and in-vitro diagnostics mandates meticulous adherence to regulatory guidelines, ensuring compliance and contributing to the availability of safe and effective healthcare products.
