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The regulatory mechanism in India is made up of a variety of primary stakeholders in the fields of biotechnology, biomedical sciences, forestry, health care, animal science and the environment. The Indian drug regulatory system is therefore divided into central (federal) and state (provincial) authorities.
In recent times, India has emerged as the world's leading manufacturer of medical products. The medical device industry is a multi-product sector, manufacturing a wide variety of products. India's medical sector is rising as a key market for medical devices and diagnostics. These medical devices have not been controlled at an early stage, but according to the amended Drugs & Cosmetics Act, 1940, in 2006, the Central Drugs Quality Control Organization (CDSCO) clarified that medical products must be controlled under the Medical Device Regulations, 2017. CDSCO will also control the import, manufacture, distribution and selling of medical devices.
The goal of CDSCO is to safeguard and improve public health by ensuring the safety, effectiveness and efficiency of medicines, cosmetics and medical devices. CDSCO also regulates the standard of imported medical devices in port offices by the Central Licensing Authority and the State Licensing Authority. Although there is a limited list of regulated products, CDSCO periodically adds new items to the lists as well as changes to the regulatory framework in India. This article provides a summary of India's current regulatory system.
The new regulatory framework published by the Central Drugs Standard Control Organization (CDSCO) has developed new guidance documents or legal documents for the registration and re-registration of notified medical devices. Those legal guidelines were drawn up on the basis of the 2017 regulations on medical devices, which legally came into force on 11 January 2018. CDSCO is authorised for approving the application for permission to import medical devices in India, Import, Distribution And Registration Of Medical Devices In India.
In India there is a specific permission required to be obtained from the CDSCO for the import of medical device in India:
1. In Vitro Diagnostic Test Kits or medical test kits or In Vitro diagnostic Devices (This includes importing Covid Test kits like RT-PCR, Rapid Test Kits, Antigen Kits and Antibody Kits. This also includes HIV, HBsAg and HCV)
2. Disposable Hypodermic Syringes
3. Disposable Hypodermic Needles
6. Drug Eluting Stents
14. Internal Prosthetic Replacements
Chapter 5 of the 2017 Medical Rules applies to the Legislation on the Manufacture of Medical Devices for Sale and Distribution in India. Any approved agent who already holds a license to manufacture medical devices for sale or distribution can apply for an import license. In addition, any wholesaler who wishes to import medical devices for sale and transfer shall also apply for an import license.
An importer of Rapid test kits for Corona Virus or Covid-19 strain will need to apply for permission for import of such kits. Any foreign manufacturer willing to supply test kits for corona virus in India will need to avail this permission for import in MD 15.
The licensing process is governed by the Ministry of Health and Family Welfare of the Central Government. The Ministry has an electronic portal from which an application for an import license has to be made. The application shall be made to the Central Licensing Authority using Form MD-14.
The applicant is also expected to request a number of additional documents along with the verification application form. First and foremost, the application must have a cover letter in the appropriate format and contain the correct information for the submission. We at Corpzo help our clients design an immaculate cover letter for their submission.
In addition, the applicant must apply a valid wholesale / manufacturer license for the Indian medical device agent. This is an essential prerequisite for the submission of an application. The applicant must also apply a Free Sales Certificate (FSC) with the submission. A Free Selling Certificate (FSC) is a document that means that the medical devices being imported are freely available on the open market in the exporting country and are licensed for export and trade liberalization.
For the importation of Class A, B, C & D In Vitro Diagnostic Kits, the applicant (foreign manufacturers) must apply the documentation as set out in Part I, Part II and Part III of the Fourth Schedule (Appendix I & III only), along with the fee specified in the second Schedule of the new medical device rules.
An approved agent holding a manufacturing or wholesale license for sale and distribution issued pursuant to MDR 2017 may, on behalf of the distributor, apply to the Authority for an import license for IVD in Form MD-14. The license will then be obtained in the form MD-15.
The licensing process is governed by the Ministry of Health and Family Welfare of the Central Government. The Central Drugs Standard Control Organization (CDSCO) has created a separate online safety platform for the Pre-Registration of Applicants prior to filing for registration of their expected Vitro Diagnostic Kits in India.
The CDSCO Online Licensing Portal was launched on 14 November 2015 and was called "SUGAM." It is a secure, fast and spam-free portal launched by the Ministry of Health and Family Welfare. Our team of experienced professionals will be pleased to represent you on Sugam Registration.
The applicant is required to submit various documents required for import registration in India as specified in the Part II of the fourth schedule of the new medical device rules.
1. A Cover Letter in proper format mentioning the following details:
a. Details of the Intended product
b. Details of Manufacturing Site (Foreign Manufacturer)
2. Regulatory documents and attachments are to be filed in MD-14
3. Power of Attorney
4. ISO 13485 Certificate
5. TR6 Challan
6. GMP Certificate
7. CE Design Certificate
8. Declaration of conformity
9. PMS Report
10. Business Licence/Plant Registration Certificate
11. Audit Report
12. Constitution Details of the Indian Agent
13. Applicant needs to submit a valid wholesale or manufacture licence for the Indian agent or the Indian counterpart for registration s importer of In Vitro Diagnostic Kits
14. Free Sale Certificate (FSC) needs to be submitted along with the application. A Free Sale Certificate (FSC) is a document which denotes that the intended In Vitro Diagnostic device being imported are freely sold in the open market in the exporting country and are approved for export and trade liberalization.
15. Full Quality Assurance Certificate of the Foreign Manufacturers to ensure that the devices are of a good quality.
16. Schedule D(II) or Device Master File specifying technical, clinical and safety related information and test data of the medical device being imported.
17. A plant master file/quality manual mentioning the following details of the foreign manufacturer:
a. Details of the manufacturing procedure of In-Vitro Diagnostic Device
b. Details of the source of antigen/antibody, as the case may be
c. Characterisation of the antigen/antibody, as the case may be
d. Process Control of the coating of antifa/antibody on the base material like nitrocellulose paper, strips or cards of ELISA wells etc.
e. Detailed Composition of the In Vitro Medical/Diagnostic Device
f. Medical Flow Chart Process of the In Vitro Diagnostic Device
g. Test Protocol showing the specifications and methods of testing
19. Batch Release Certificate: In the case of imported diagnostics, a comprehensive evaluation report by the National Control Authority of the country of origin, a sample batch test report for at least three consecutive batches showing the specification of each test parameter.
20. Detailed test report of all components used / packaged in the finished in vitro diagnostic medical device, package size and labeling, product inserts, detailed evaluation report, if carried out by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device and basic processing specifics such as safe handling, material control, area control, process control, etc.
21. Free Sale Certificate (FSC) provided by the national regulatory authority or any other competent authority in any of the countries (Australia, Canada, Japan, the countries of the European Union or the United States of America).
As per Rule 36 sub-rule (1), the Central Licensing Authority may, on being satisfied, grant the licence in Form MD-15 or, may accept or reject such application for which the reasons shall be recorded in writing, within a period of nine months from the date of application.
Team Corpzo has succeesfully delivered over 53 Licences (MD-15) . In our experience the licence ususally gets approved within 20 days of application given that the documents required and prerequisites are relegiously fulfilled.
ANS: In order to import an type of medical device including In-Vitro Diagnostic Devices for covid (including RT-PCR kits, Rapid Test Kits, Antigen Test Kits and Antibody test kits)
Q: What is MD-15?
ANS: MD-15 is a permission to import Medical devices in India MD-15 is a permission to import any type of medical device (including In-Vitro Diagnostic Kits) in India. This License/permission is granted by CDSCO and is to be mandatory applied by a person who wishes to import medical equipment or In Vitro Diagnostic Devices.
Q: Who needs permission to import in MD 15?
ANS: Any person who wishes to import medical equipment or In Vitro Diagnostic Devices of any kind manufactured or supplied a person outside India needs a permission to do so.
Q: What is the governing body for grant of permission to import medical devices?
ANS: All medical devices are governed by the Indian Drug Controller General (DCGI) under the Central Drugs Standard Control Organization (CDSCO); part of the Ministry of Health and Family Welfare (MHFW).
Q: What is a Medical Device?
ANS: 'medical device' means,-(a) an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or accessories, intended by its manufacturer to be used specifically for humans or animals which do not have the primary intended effect on the human body or animals by any pharmacological or immunological or metabolic means;
Q: What are the categories of Medical Device defined under the Medical Device Rules?
ANS:
|
INTERNATIONAL CLASSIFICATION |
EXAMPLES |
RISK LEVEL |
TYPE OF REGULATION |
|
Class A |
Thermometers, tongue depressors |
Low |
License not required but voluntarily applied to be licensed by State Licensing Authorities (SLA) |
|
Class B |
Hypodermic needles, suction equipment |
Low Moderate |
Approval by the SLAs |
|
Class C |
Lung ventilator, bone fixation |
Moderate High |
Approval by Central Licensing Authority (CLA) |
|
Class D |
Heart valves, implantable devices |
High |
Q: What is the Process of Approval?
|
PREMARKET APPROVAL PROCESS * |
|||
|
CLASS A |
CLASS B |
CLASS C |
CLASS D |
|
SELF-REGULATION |
APPROVAL BY SLA |
APPROVAL BY CLA |
|
|
Application for registration (appoint an authorized Indian agent) |
|||
|
Registration certificate issued by CDSCO |
|||
|
Application for import license |
|||
|
Import License issued by CDSCO |
|||
Q: What is the validity if this licence?
ANS: New Medical Device rule published in October, 17, 2016. Device registration do not expire but keep paying the fee every 5 years.
Q: Do the Medical devices which have already been marketed in India before the start of these rules need this licence?
ANS: Medical devices which have already been marketed in India before the start of these rules shall continue to be marketed as before the expiry of 18 months or the current validity of the license from the beginning of these rules.
Such devices are known as Predicate: It is one of the most important things under the process of registration. Hence, it is a must to have a predicate device locally in India. Without a predicate device the process becomes tedious and time consuming. If a predicate is not available the application is to be filed vide MD-26 and registration is to be obtained in MD-27.
Q: Is there any additional licence required for this licence?
ANS: A license shall be granted if the medical device has a Free Sale Certificate (FSC) provided by the national regulatory authority or any other competent authority in any of the countries (Australia, Canada, Japan, the countries of the European Union or the United States of America).
Q: What are the types of licence for importing of medical devices required by foreign Companies/manufacturers in India?
ANS:
a) Manufacturing License of Medical Devices
For an application for a license to manufacture for distribution/sale of Class A & B devices, the application should be made online in Form MD- 3 or Form MD- 4 (for loan license) along with a fee. The license will be obtained under Form MD-5 or Form MD- 6 (for loan license).
For an application for manufacture for distribution/sale of Class C & D devices, the application should be made online in Form MD- 7 or Form MD-8 (for loan license) along with a fee. The license will be obtained under Form MD-9 or Form MD- 10 (for loan license).
b) Medical Devices
An application should be made online to the Central Licensing Authority (CLA) under Form MD- 14 for obtaining a license to import for sale or distribution via an authorized agent already possessing a license for manufacture for sale/distribution of medical devices or a wholesale license for sale/distribution of medical devices.
If the registration is compliant, the license will be issued under Form MD-15.
Call or WhatsApp us on +91-99991-39391 for free consultation from our team of experts. You can also email us on reach@corpzo.com.
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
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