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Importance of Registration Holder Support for Drugs
Date : 2023-11-21
In the realm of pharmaceuticals, a vital link connects drug manufacturers, regulatory bodies, and patients: the registration holder. The registration holder plays a pivotal role in shepherding drugs through the complex landscape of regulatory processes. While the concept of a registration holder might seem straightforward, its role goes far beyond administrative tasks. It ensures patient safety, regulatory compliance, and the availability of essential medications. In this blog, we will explore the importance of registration holder support for drugs and how it plays a crucial role in ensuring patient safety and regulatory compliance.
Who are Registration Holders for Drugs?
Registration holders, also known as authorized agents, are critical players in the pharmaceutical industry who shoulder the responsibility of obtaining and maintaining the necessary approvals from regulatory authorities for drug products.
\"Registration holder\" refers to an individual or entity in India authorized by a foreign company. The designated agent assumes responsibility for handling the import and business operations of the foreign company within India, ensuring strict adherence to all provisions outlined in the Drugs and Cosmetics Acts. Their role is multifaceted and plays an important role in ensuring patient safety, regulatory compliance, and the overall success of drug development and distribution.
Role of Drug Registration Holders
The role of the drug registration holder in the pharmaceutical industry is indispensable. Their support is the backbone of drug development, ensuring that medications meet stringent regulatory standards and that patients receive safe and effective treatments. Their expertise in regulatory compliance, pharmacovigilance, and quality assurance contributes to patient safety, while their commitment to post-marketing studies ensures continuous improvement in drug development.
Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Drug registration in India.
Significance of Drug Registration Holders
The significance of a drug registration holder lies in their pivotal role as a representative of a foreign pharmaceutical company in India. They play a crucial part in facilitating the import, distribution, and business activities of the foreign company within the Indian pharmaceutical market. Let\'s explore the key aspects that highlight the significance of authorized agent support for drugs:
Facilitating Regulatory Processes
The journey of a drug from the laboratory to the medicine cabinet is fraught with regulatory hurdles. This is where the registration holder steps in as the liaison between the drug manufacturer and regulatory agencies. They are responsible for compiling all necessary data and documentation required for submission to the regulatory agency. Their expertise in navigating the intricacies of regulatory processes expedites the approval timeline, ultimately allowing patients faster access to life-saving treatments.
Ensuring Compliance with Regulatory Standards
The drug authorized agent ensures that the foreign pharmaceutical company operates in full compliance with the provisions of the Drugs and Cosmetics Acts in India. They act as a bridge between the foreign company and the Indian regulatory authorities, ensuring that all legal requirements are met, and necessary approvals and licenses are obtained.
Market Entry and Expansion
For foreign pharmaceutical companies looking to enter or expand into the Indian market, the authorized agent serves as a local partner with a deep understanding of the regulatory landscape and market dynamics. Their expertise and knowledge of the Indian pharmaceutical sector are invaluable in overcoming entry barriers and ensuring a smooth market presence.
Import and Distribution
The authorized agent handles the import and distribution of the foreign company\'s drugs within India. This includes obtaining import licenses, managing customs clearance, and ensuring efficient distribution channels to reach healthcare providers and patients across the country.
Local Representation
Having a local representative is essential for foreign pharmaceutical companies to effectively navigate the Indian market\'s unique challenges, cultural nuances, and business practices. The authorized agent acts as a point of contact for the company\'s Indian customers and stakeholders, enhancing communication and understanding.
Pharmacovigilance and Adverse Event Reporting
The authorized agent plays a critical role in pharmacovigilance, which involves monitoring and reporting adverse events related to the foreign company\'s drugs in India. Timely and accurate reporting of safety concerns is crucial for patient safety and regulatory compliance.
Efficient Market Access
With the support of an authorized agent, foreign pharmaceutical companies can navigate the complex registration and approval processes in India more efficiently. This streamlines market access, allowing patients to benefit from innovative treatments sooner.
Conclusion
The role of the registration holder in the pharmaceutical industry cannot be overstated. Pharmaceutical companies must recognize the importance of selecting a reliable and experienced registration holder to represent their drugs. They serve as a reliable partner, ensuring compliance with regulations, handling market entry and distribution, and fostering effective communication with local stakeholders. Their support is instrumental in navigating the complex regulatory landscape, ensuring patient safety, and maintaining compliance with evolving standards.
For more information, visit our website clinexperts-research.com
ISO 13485:2016 - Medical devices Quality Management Systems | ISO 13485 for Medical Devices QMS
Date : 2023-11-21
ISO 13485:2016 - Medical devices — Quality management systems —Regulatory requirements
When a company decides to go for QMS (quality management system) and get a certificate in ISO 13485, there are millions of questions. There is a list of 12 steps that one needs to follow so that nothing is left behind while implementing it in the company.
Introduction to ISO 13485 –
ISO 13485:2016 stipulates all the quality management system requirements required by an organization to show that it can provide medical devices and related services while following all the regulatory requirements.
Organizations can handle more than one stage of medical device life like life cycle, design and development, manufacturing, storage and distribution, installation and servicing.
Even medical device suppliers or external parties that handle products need to follow a quality management system.
QMS applies to all organizations irrespective of the size and type of organization otherwise mentioned.
ISO 13485 revisions and main advancements –
All the standards are reviewed and revised if needed at a time interval of five years to keep up-to-date.
ISO 13485:2016 medical device quality management system is up to date with the latest changes required in the Quality management system, including regulatory and technology requirements.
The main focus of the updated version is risk management and decision-making based on risk, as well as changes in the supply chain due to changes in regulatory requirements.
Steps to obtain ISO 13485:2016 Certification – There are fourteen an organization needs to follow to get the ISO 13485:2016 certificate.
Step 1: Managements support –
An organization needs to have management support to get the ISO 13485:2016 certificate. The best way to onboard the management is to show them the benefits of the ISO 13485 certificate and how it will help them to get more business.
Benefits of ISO 13483 –
Legally Compiled
More Trusted Business Reputation
International Business Opportunities
Ability to have more business
Better access to information
More customer satisfaction
Less Operating cost
Controlled Risk management
Step 2: Review of documents and requirement study-
Get a copy of ISO 13485:2016 and the supporting documents, and make sure the standard used is the latest.
For this part, one needs to refer to the clauses given in the standard form, clause 4 to clause 8.
These documents are crucial while outlining the implementation plan and will be reviewed by the auditor.
Step 3: Scope of ISO 13485:2016-
There is no need to apply QMS where quality is not a parameter to concern but don\'t narrow it down so that organization sees no benefit.
Defining the scope will help to set the boundaries for the implementation in an organization. It will help in defining the quality policy and quality manual.
Step 4: Outline the Process and procedure-
ISO 13485 consists of many processes and procedures; thus, an organization must define their process and procedure to ensure consistent and satisfactory quality.
Step 5: Gap analysis-
Gap analysis is the process of comparing an organization\'s existing process with that of the ISO 13485.
It will help to understand the gap between the organization\'s existing processes and those that need to be established.
The gap analysis will help make an informed decision on the implantation process.
Gaps can be wider or smaller. Wider needs more sweeping changes as compared to minimal changes for small gaps.
Step 6: Implementation plan-
Addressing the gaps is the crucial step in getting the QMS certificate.
There is no need to document every process; only major processes that guarantee quality need to be documented.
It will include designing quality manuals and policies, i.e., inspecting the existing process and making the necessary updates.
Methods to create documents need to be covered.
Step 7: Training –
All the employees who will be part of the implementation need to be trained in QMS to understand its working and how they can fit in.
Communicate the effect of QMS implementation, their responsibilities and how it will benefit them.
Step 8: Plan continuation-
Implement the plan as per the design, monitor it closely, and make the required changes.
Document every change and make sure the related employee is informed.
Step 9: Internal audit and review –
Before the third-party audit, an internal audit is conducted of each process to know if the plan\'s performance is as per planning or not.
An internal audit checklist of medical device ISO 13485 needs to be prepared, which will help in the inspection, and make sure to file the findings carefully.
Audits can be used as evidence that the processes are working suitably and meeting the essential requirements.
Step 10: Management review-
During the management review, the QMS activities data is examined to ensure the process is effective and is improving the quality.
Step 11: Corrective action-
Here the organization will look for the reasons and take corrective actions for the problems that came across during the internal audit and management review.
Organizations can make changes before the third-party audits.
Step 12: Certificate body selection-
Choosing the right certificate body is a crucial step as it comes after implementing the changes after conducting of internal audit and management review.
It will determine whether the organization is legally complied with ISO 13485 or not.
Choosing the right auditor is necessary as this audit is conducted on-site, and thus right auditor will reduce the language or cultural barriers.
Step 13: Third-part audit-
The auditor will review the documents and will verify whether all the requirements of medical device QMS have been implemented or not.
An application containing information on the organization\'s background and details of implantation will be submitted.
The assessment phase starts once the organization provides enough evidence that QMS has been operated for at least three months and the full cycle of internal audit and management review cycle has been followed.
If there is any non-compliance, the auditor will describe it or is passed next assessment visit is scheduled.
Step 14: Surveillance audits-
A partial surveillance audit will be conducted for the three-year cycle certificate, also called a maintenance audit.
It mainly covers internal audits, management reviews, corrective action, and critical processes.
It occurs once a year, and the cycle starts again after three years if the organization continues to maintain QMS certification.
ISO 13485 Certification – Basics Of ISO 13485 Quality Management System For Medical Devices
Date : 2023-11-21
ISO 13485 Certification
In the majority of ISO management standards, certification in conformity to ISO 13485 doesn\'t constitute a requirement for the standard. Companies can reap the benefits of following the measures without going through the certification process. Third-party certification will prove to authorities that you have met the standard\'s requirements.
Important \"ISO 13485 Certified\" means an organization has adopted the ISO 13485 Quality Management System and successfully fulfilled the requirements of the standard. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while focusing on the safety and effectiveness of medical devices.
What is ISO 13485 Certification For Medical Devices?
Certification ISO 13485 For Medical Devices
Who Is ISO 13485 Designed For?
ISO 13485 Quality Management System Standard
Scope
Normative references
Terms and definitions
Quality management system
Management responsibility
Resource Management
Product Realization
Measurement, analysis, and improvement
Process To Get Medical Device Manufacturing License / Permission For Manufacture Class C & D Medical Device
Date : 2023-11-21
Step-by-step Process To Get Medical Device Manufacturing License / Permission For class C & D Medical Device
Medical device manufacturers must register under the MDR 2017 to manufacture medical products. The Medical Device Rule 2017 states that an application needs to be submitted on the Sugam Portal to get manufacturing permission for class C and Class D medical devices.
If a Class C or Class D medical device is being manufactured, the manufacturer will need to apply for permission for a manufacturing license to the Central Licensing Authority (i.e., CDSCO).
Class C Medical Devices Classification
The Classification System of Medical Device Rules, 2017, as the below medical devices in Class C.
Non-invasive medical equipment for channeling or stocking substances referred to in sub-clause shall be assigned Class C if it\'s a blood bag that does not contain a medicine product.
Non-invasive medical equipment for the modification of compositions of substances that are subject to sub-clause(b) shall be assigned Class C if it\'s intended for altering the biological or chemical makeup of blood, other body liquids, or other liquids for infusion into a body.
Sub-clause (b) applies to invasive medical devices (body orifices) for long-term usage. If it is intended for long-term use, an invasive medical device (body orifice) shall be assigned Class C.
Transient surgically invasive medical equipment shall be assigned the same classification as the active medical device it is meant to connect.
Short-term surgically invasive medical equipment Subject to subclause (c), Class C will be assigned to any device that is intended for a chemical change in a body or for the administration of any medical product or the supply of energy in ionising radio radiation.
Class C shall be assigned to surgically invasive medical equipment and implantable medical device for long-term usage subject to sub-clauses b, c, and d.
Class C shall be given to an active therapeutic medical instrument if it is intended to control, monitor, or directly influence the performance of a Class A active therapeutic device.
Class C shall be given to active diagnostic medical devices, as defined in sub-clause(a) if they are intended for monitoring.
If a medical device is used for contraception or to prevent the transmission of any sexually transmissible disease, it shall be classified as Class C.
Class D Medical Devices Classification
The medical device rules 2017 have the following medical devices classified under Class D.
If a surgically invasive medical device is for temporary use, it will be classified as Class D under the classification system. This applies if it is specifically intended to be in direct contact with the central nervous system or to diagnose, monitor, or correct a defect in the heart of central circulatory systems.
If a surgically invasive medical device is for short-term use, it will be classified as Class D if it has a biological effect, or is wholly, mainly, or primarily absorbed by the body, or to be used for diagnosis, monitoring, or correction of a defect in the heart or central circulatory system via direct contact with those parts.
This new classification will be applied to implantable medical devices as well as surgically invasive medical equipment for long-term use. It is only allowed to be in direct contact with the heart, central circulatory system, or central nervous system.
Sub-clause (b), medical devices that incorporate medicinal products shall be classified as Class D. If it includes an integral part of a substance, it may be considered a medicinal product. It is also liable to act upon a human body with an action that is ancillary.
If medical devices that incorporate animal or human cells, tissues, or derivatives are subject to sub-clause b, they will be assigned to Class D if they are made from, or incorporate, cells, tissues, derivatives of cells or tissue, or any combination thereof, which have been or become non-viable.
If it is an implantable or invasive medical device for long-term use, medical devices for contraceptive purposes referred to under clause (a) shall be assigned Class D.
Process To Get Manufacturing Permission for Class C And D Medical Device
Step 1 - Application for Manufacturing Licence
The applicant must submit an online application at the CDSCO portal CDscomdonline.gov.in. Fill out the form MD-7 for a license to be issued on MD-9 or as required by the Medical Device Rules. Also, include the necessary documents and fees.
Upload mandatory documents with the application form for class C and Class D medical device manufacturing permission -
1. Covering Letter
2. Application Form
3. Receipt challan fees
4. Incorporation of firm
a. Partnership deed/ Memorandum and Article of Association
b. Declaration of the Proprietor/ Partners/ Director(s),/ Managing Director
c. List of all Partners/ Directors with their addresses and complete postal/residence addresses.
5. Documents of site ownership / Tenancy agreement
6. Plant Master File (as per Appendix I of Part III, fourth schedule).
Other than the information required under appendix 1 of Part III, the fourth schedule, you should also submit the following documents:
a. Declaration of Manufacturing Chemist.
b. Declaration of Analytical Chemist.
c. Documents proving educational qualifications, experience, and approval certificates for the proposed Manufacturing Chemist & Analytical Chemist; Appointment letter; ID proof.
d. Registration through District Industries Centre
e. Consent of Rajasthan State Pollution Control Board to establish and consent to operate.
7. Device Master File for each product (as per appendix I/appendix III of the Fourth Schedule)
8. Performance Evaluation Report (if relevant)
9. If applicable, a copy of the Test License
10. Assure that the manufacturing location is in compliance with the Fifth Schedule.
Step 2 - Application review
Any discrepancy/deficit should be reported. Once the applicant has replied to their query, further action is taken. If the application is deemed in order, it can be submitted for inspection of factory premises by a notified entity as per Medical Device Rules.
Step 3: Application Audit
Audit of applicant premises by CDSCO. The applicant will rectify any non-compliances.
Step 4 - Audit Results
The audit report will be received and will be reviewed. If it is satisfactory, it will then be sent on to the next stage.
Step 5 - Products Scrutiny
The application to manufacture class C & class D medical devices will be reviewed and granted a license if the details of the product are in conformity with the norms.
Step 6 - Grant of License
Class C and Class D medical device manufacturing permission will be granted when all conditions have been met.
Anybody who would like to manufacture Class C & D Medical Devices may submit Form MD-7 to request permission. The CDSCO reviews your application. A Notified body may inspect the manufacturing site. Medical Device Officers might also inspect it, either with or without an engineer. CDSCO can issue the MD-9 license upon this basis.
CliniExperts serves as India\'s authorized agent for medical devices. It holds a valid Drug Wholesale License and has a strong position in Indian Healthcare. CliniExperts offers expert support for all aspects of the application process, including the submission and processing of Form MD-7. These licenses will be used to distribute or manufacture Class C and D medical devices.
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Required Documents for Class C - D Medical Device Manufacturing License Approval
Date : 2023-11-21
Required Documents for Class C - D Medical Device Manufacturing License Approval
Device master file, site master file, and quality management system documents are necessary for getting manufacturing permission for Class C and D Medical Device.
Summary
The applicant can submit their application via Form MD-7
Essential documents during the application process include the device master file, site master file, and quality management system documents
CDSCO grants license after reviewing Form MD-7 and conducting an inspection
Medical Device Manufacturing License Approval
The Central Drugs Standard Control Organisation (CDSCO) supervises the manufacturing of notified medical devices in India. This regulatory body handles granting licenses and approval of the manufacturing of medical devices.
The manufacturer must apply for the Grant of License to sell and distribute Class C and D Medical devices. As per the Medical Devices Rules (MDR), 2017 provisions, CDSCO grants license approval for manufacturing Class C or D Medical devices in Form MD-9.
For obtaining manufacturing permission, device master file, site master file, and quality management system documents are necessary.
Forms required for medical device manufacturing permission
Two forms are essential for availing the manufacturing approval of medical devices. The forms are as follows:
Form MD-7: The application form required to be submitted for a manufacturing license
Form MD-9: The License obtained for the manufacturing of Class C or D Medical device
Eligibility and the process of application for medical device manufacturing
Any individual who wishes to manufacture Class C and D Medical Devices can apply to the Central Licensing Authority via Form MD-7. In addition, the applicant can submit the application forms via an online portal of the Central Government.
The documents mandatory during the application process are listed in table 1. The applicant must prepare the technical documents carefully per the latest MDR guidelines. Failure to do so may cause postponement in submission or other problems.
Required Documents For Medical Device Manufacturing License Approval
Sr. No. | List of documents required for medical device manufacturing |
1 | Cover letter |
2 | Device and site master files |
3 | The establishment, tendency, and site ownership agreement of the firm |
4 | Quality Management System Documents which are specified as per the 5th schedule of Medical Device Rules and performance evaluation report (Only in vitro diagnostic device) |
5 | Valid copies of the Quality Certificate of the manufacturing site (Should be duly notarized) |
6 | Valid Test License (for the testing and generation of quality control data) |
7 | A signed undertaking which should state that the provisions of the Fifth Schedule are being followed |
Table 1: Documents required while applying via Form MD-7
The government charges for one Class C or D manufacturing device is 50000 INR, whereas the cost for each distinct medical device is 1000 INR.
Inspection for issuing Form MD-9 license
After the individual submits Form MD-7, CDSCO will review the application. This can be followed by an inspection of the manufacturing site, which is done by Medical Device Officers or a Notified body.
The inspection will be conducted within 60 days from the date of application. An expert may or may not accompany Medical Device Officers or a Notified body during the examination.
Based on the results obtained during the inspection, CDSCO may grant the license in Form MD-9. The license is granted within 45 days after receiving the inspection report.
Validity of the License
The Form MD-9 license does not have a fixed time for expiry. This license can be valid forever; however, as per the Second Schedule, the license retention fee must be paid promptly within five years of the issue date.
If the license holder does not make timely payments, the license will get cancelled or suspended.
Medical Device Import License For Test, Clinical Investigation, or Evaluation – Timeline, Government Fee, Required Documents, Validity
Date : 2023-11-21
Medical Device Import License For Test, Clinical Investigation, or Evaluation – Timeline, Government Fee, Required Documents, Validity
In accordance with the latest medical device regulations 2017, an applicant who is planning to import small quantities of medical devices to be used for testing, examination, or analysis, can submit an application in the form MD-16 in the condition that the medical device on the form 17 cannot be utilized for any commercial use. The Central Licensing Authority must submit the application along with certain documents that are required. The medical device license that is required for this application will be granted on the form MD-17 from the Central Licensing Authority.
CliniExperts assists its clients in creating the dossier required for submitting a test license application for the medical device. As we mentioned previously, the required documents should include a cover letter clearly detailing the specifics of the product, such as the name, classification, and the reasons for the quantity that is of the product that will be imported. Additionally, a test protocol/approved clinical investigation plan/testing method used to test the medical instrument, quality certificates such as QMS or Specimen Label, and an undertaking that states that the device to be imported will not be used for commercial purposes.
Permission To Medical Device Import License For Test and Clinical Investigation
New Medical Device Rules 2017 have classified the categories of medical devices into four broad categories based upon the risk classifications for the particular products. To get permission for a test license to import a medical device, it is necessary to understand the classification so that we know the proper fee structure to grant approval. The following table suggests the application form, approval form, and fee structure will be based on medical products\' risk classification.
Medical Device Test License For Importer Application Form
Form MD 16 - Application for Test License to Import Medical Devices for the Purposes of Clinical Investigations or Evaluation or Demonstration or Training
Form MD 17 – Approval of License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Government Fee For Test License For Medical Device Import
The predefined fee for getting a test license in Form MD 17 to import medical devices is $100 / per product.
Required Documents For License Approval To Import Medical Device Test
The applicant must upload all the necessary documents and the required fee on the online Sugam portal along with form MD 16. The necessary documents for Licence to Import Medical Devices for Clinical Investigations or Test or Evaluation or Demonstration or Training –
Applicant’s name, address, contact number, email id, etc.
Name and address of medical device manufacturer
Proposed clinical investigation site name and address
Medical device(s) details that are going to be imported
Medical device brief description
The motive for medical device import
Justification for the medical device quantity you want to import
An undertaking that states that all necessary facilities, instruments, equipment, and personnel are in place to test or evaluate a medical device(s).
An undertaking that the specific medical device is proposed to be imported will be used only for the specific purposes as indicated by number 7 . It will not be utilized for any commercial purposes.
Receipt, challan, and transaction id of the paid fee.
Declaration
Timeline for Medical Device Import Test License Approval
The preparation of documents for regulatory compliance is an extremely time-consuming and laborious process. If you are an importer or a foreign manufacturer, you\'re immersed in a variety of aspects of the business prior to launching the medical product in India. If an error occurs, it could cause a complete delay in the process of addressing regulatory issues and business plan overheads, financial planning problems, and disruptions in the supply chain. The predefined timeline to import medical device test license approval is 30 working days.
Validity For Medical Device Test License For Importer
A medical device test license for the importer is valid for three years unless it is suspended or cancelled earlier.
Do you need permission to import medical devices into India to show its performance? CliniExperts professionals are experts and will assist you in obtaining an import permit for medical devices to conduct clinical investigations and evaluation using the form MD 17 issued by CDSCO. It is possible to import a tiny quantity of Class A / Class B / Class C / Class D medical devices into India. The test license may be used to test or evaluate, demonstrate, or even train for medical devices. Central Drugs Standard Control Organization (CDSCO) is the authority for regulation in India that issues the test license for medical devices.
CliniExperts supports you with the easy preparation and submission of these documents and going through the lengthy application process. Our experts will make sure that the submission is perfect and has the highest likelihood of being approved in the shortest time possible.
Process To Get A Medical Device Import License for Testing, Clinical Evaluation or Investigation in India
Date : 2023-11-21
STEP-BY-STEP PROCESS TO GET AN IMPORT TEST LICENSE IN INDIA
Medical devices are tested to prove that they are safe for both the user and the operator.
Medical device testing should occur in NABL accredited labs. Applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority
In medical device rule,2017 Chapter V with title import of medical device has sub-rule (40) which states that:
Applicants can import any medical device for clinical investigation, testing, assessment, demo, or training.
The CLA (central licensing authority) handles the import of medical devices for any purpose.
Anyone who wants to import a medical device for any investigation can apply through Form MD-16.
Form MD 16: The application to import medical devices for testing, evaluation, demonstration, or training.
Form 17: It is the permission to import medical devices for testing, evaluation, demonstration, or training.
If the CLA gets a satisfactory response from the applicant during the inquiry, then permission to import medical devices is granted.
Application form | Approval form | Class | fees | Licensing authority |
Form MD-16 | Form MD-17 | USD 100 | CDSCO |
Steps to get the Test License(Import) in India:
Step 1 – Chapter V, rule 34 states that:
Medical devices imported shall be used exclusively for clinical testing, evaluation, demo, and training and not for any other purpose.
The applicant shall mention where testing will be done in the test license.
The applicant shall give prior information to CLA if the medical device needs to be taken to any other place for testing.
The license holder needs to document the activities, manufacturer name, import quantity, and date.
The invoice shall be present along with the medical device\'s quantity and name.
Unused Medical devices can be exported back or destroyed as per CLA orders.
Step 2 – Fill out the Form:
Fill the Form MD -16 at cdscomdonline.gov.in.
Note: If the person who wants to get a test license is not from India, then they need the help of the authorized agent.
The authorized agent must have a valid wholesale or sale or manufacturing license.
Step 3 – Pay the fees
Fees Rs. 100 USD under the head of the account through the government treasury challan.
Step 4 -Collect the documents: Technical documents to import test licenses for medical devices.
Cover letter
A brief description of the medical device, intended purpose, construction material, and design shall be present.
Quantity justification imported
Protocol of test, clinical investigation (if any)
Quality certificate, QMS of the manufacturer
Labels, IFU
An undertaking declaring the medical device planned to import will be used solely for testing purposes mentioned in serial 7 of MD-16 and will not be used commercially.
The applicant will provide a declaration from the testing laboratory declaring the types of equipment, instruments, and human force to test the medical device.
Fees
Legal form
Step 5 – Decision of CLA
If CLA is satisfied with the report, then a test license to import medical devices for testing is granted in Form MD – 17.
If CLA is unsatisfied with the report, it rejects the application.
License validity –
The validity of Form MD – 17 is for three years.
If, in any case, the license gets suspended or cancelled, then the applicant can apply within 45 days from the action date.
Summary –
To compensate for the increasing demand for medical devices in India, the government is launching new policies to import medical devices smoothly and quickly.
India\'s government is continuously strengthening the infrastructure required to test medical devices and prepare detailed SOPs.
The government plans to make medical device testing mandatory in the coming years.
Hire CliniExperts Medical Device Import License Consultant to get support for Medical Device Import Test License in India
Important Documents for Medical Device Manufacturing License for Class A / B Medical Devices - ISO 13485, Device Master File, Site Master File
Date : 2023-11-21
Medical Device Master File, Site Master File, Quality Management System As documents
Class A and Class B devices must undergo rigorous processes that must be completed according to the guidelines and rules set by the Central Drug Standard Control Organisation (CDSCO). Furthermore, those who plan to manufacture medical devices of Class A and Class B must undergo a process through the application process for a permit to market and distribute medical equipment. The CDSCO assures the quality and safety of medical devices that are sold on the market by this method.
These applicants need to submit an application for approval to the State Licensing Authority for approval through the Department of Health and Family Welfare\'s web portal, based on the location of the applicant. A request must be made in FORM MD-3 along with the necessary documents required to get the license in FORM MD-5.
Important Documents To Manufacture Class A Class B Medical Devices
The mandatory documents for filling the application stated by the CDSCO include:
Quality Management System Documents
Site Master File
Device Master File
Quality Management System of Medical Devices (ISO 13485) To Manufacture Medical Device Class A / B
In simple terms the definition of a medical device\'s QMS (QMS) can be described as a well-organized procedure and process that cover every aspect of manufacturing, design suppliers and managing risk, handling complaints storage of clinical information distribution, product labelling, and much more. The majority of medical devices will require some kind of QMS. The level of degree of complexity of the QMS can differ based on the class that the product is classified in. For instance, companies that make low to moderate-risk (Class B) or moderate to high-risk or high-risk (Class C-D) devices will require the use of a different QMS as opposed to companies that make low-risk non-sterile, non-measuring, and surgical instrumentation that is not reusable (Class A). We will not go into the details of classification or registration in this article however, you\'ll need to know the classifications of your medical devices prior to creating a QMS.
In highly-regulated fields like pharmaceutical and life sciences industries, specific QMS (QMS) deals with the complicated development process for biotech, pharmaceutical, and medical devices. Medical Device Quality Management Systems (QMS) is designed to help facilitate compliance with the regulations adopted through the FDA and other standards such as ISO 13485. In addition, with a medical QMS, companies in life sciences can reduce the use of paper-based quality systems enhance product quality and safety, cut overall expenses, improve operational efficiency, and integrate processes, documentation, and communications.
To be eligible to be included within the Medical Quality Management Systems (QMS) category A product must:
Create a traceability feature for products
Document and track every procedure and event that occurs throughout the lifecycle of the product.
Track industry regulations and create reminders or triggers for possible violations.
Record customer complaints to evaluate and manage the risk
Facilitate inspections and testing of products
Offer support and workflows for corrections to products tested
Important Documents for Medical Device Manufacturing License for Class A / B Medical Devices - ISO 13485, Device Master File, Site Master File. Get Medical Device Consultancy Services for manufacturers for medical device manufacturing permission for class A B Medical Device. Call @ 7672005050 to get in touch with CliniExperts\' Medical Device experts for all your medical device regulatory requirements.
