Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.
1. The Supreme Court of India has ruled that company directors and officials are not vicariously liable for corporate offences without specific statutory provisions and evidence of personal involvement. While companies may be held accountable for employee’s misconduct, directors’ liability requires proof of their direct actions. Mere association with the company is insufficient to attract a liability.
Source: bit.ly/3PvHNJK
2. The Supreme Court of India, while hearing a PIL against multinational pharmaceutical companies, raised ethical concerns over clinical trials in poorer countries. It highlighted the exploitation of vulnerable populations and the lack of oversight in such practices thereby urging stricter regulations to protect participants’ rights. The Drugs and Clinical Trial Rules, 2019, notified under the Drugs and Cosmetics Act, 1940, mandate provisions like Ethics Committees and compensation for trial-related injuries or deaths.
Source: bit.ly/3DNYBt4
3. The Jammu & Kashmir and Ladakh High Court has initiated contempt proceedings against a prominent Indian law firm for allegedly misquoting a 2010 judgment related to the Sawalkote Hydro-Electric Project. The court observed that the law firm had misrepresented judicial findings in a legal notice that was issued by the court which might potentially amount to criminal contempt.
Source: bit.ly/423xnZz
4. The Bombay High Court emphasized that intelligence levels should not determine parental rights while deciding a case involving a woman’s right to motherhood with borderline intellectual disability. The court reviewed a petition seeking termination of the woman’s 21-week pregnancy, with a medical report confirming her fitness for pregnancy.
Source: bit.ly/3Cb5Evd
5. India’s healthcare stakeholders, ahead of Budget 2025, are urging reduced customs duties (~37%) on advanced cancer therapies, drugs, and treatment equipment. They seek tax reforms, including GST rationalization, increased healthcare spending to 2.5-3% of GDP, long-term financing options, telemedicine expansion, and infrastructure incentives. Emphasis is also laid on digital health and preventive care to ensure equitable access nationwide
Source: bit.ly/4gJousH
Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.
1. The Indian government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo
2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt
3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx
4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al
5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM
Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.
1. India’s Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK
2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ
3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur
4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH Source: bit.ly/4f5AYJz
5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU
Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9
2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7
3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY
4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU
5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY
All Food Business Operators (FBOs) in India must maintain a record of annual medical examination of all food handler(s) engaged by the FBO. This is a mandatory condition of the food license. The Food Safety Officer checks the record of medical examination at the time of inspection, and any shortcoming in the record-keeping may result in suspension or cancellation of license.
In this article, we will discuss key considerations for ensuring full compliance with the requirement of maintaining records of medical examinations of food handlers.
Who is a food handler?
A food handler is any person who directly handles packaged or unpackaged food, food equipment, utensils, or food contact surfaces, and is therefore expected to comply with food hygiene requirements.
Personal hygiene and sanitary requirements applicable to FBOs
In addition to the requirement of a medical examination of food handlers, all FBOs have to ensure that no person, whether handling food or not, who may be suffering from any disease or illness that is likely to be transmitted through food is allowed to enter any area where the food is handled, i.e., where the food is packaged or unpackaged, where food equipment and utensils are stored, where food contact surfaces exist, or where food is cooked or manufactured.
In addition to the above general requirement, FBOs who are involved in high-risk food businesses such as meat and dairy have additional personal hygiene and cleanliness requirements, which are discussed below.
Meat
FBOs who deal in meat must ensure that any person who comes into contact with meat in the course of his or her work must be medically examined prior to such person being engaged. FBOs who run meat shops must ensure that any person who handles meat is medically examined annually, and the medical examination includes an examination of the sputum and chest X-ray for tuberculosis. The medical examination should also include stool tests for parasitic infections (protozoal and helminthic) transmitted through ingestion, as well as for enteropathogenic bacteria such as Escherichia coli, Salmonella, Shigella species, and Vibrio cholera.
Dairy
FBOs who manufacture, process, store, or sell milk and milk products are required to ensure that the persons employed for handling raw materials or dairy products have, before joining, submitted a medical certificate that states that there is no medical impediment to working in the specific capacity or role that the person is going to be employed by the FBO.
Mandatory vaccination of workers working in food factory
If the FBO is a manufacturer, processor, and packer who operates a factory, then all workers working in the factory ought to be compulsorily vaccinated against an enteric group of diseases as per the recommended schedule of vaccination. Enteric groups of disease are infections caused by viruses and bacteria that enter the body through the mouth or intestinal system, primarily as a result of eating, drinking, and digesting contaminated food or liquids. Cholera, typhoid fever, Salmonella, or E. coli are some common enteric diseases. A record of the vaccination of all factory workers is required to be maintained, which may be inspected at the time of inspection. The decision regarding the scope of vaccination, i.e., which enteric diseases are to be covered by vaccination, is taken by the registered medical practitioner according to the list declared by the concerned municipal corporation of the area.
Format of Medical Fitness Certificate
After the medical examination of food handlers, a medical fitness certificate in the prescribed format must be issued by a registered medical practitioner. It must contain the signature and seal of the registered medical practitioner. The medical fitness certificate should indicate that the registered medical practitioner has undertaken a physical examination, an eye test, and a skin examination, as well as any other tests required to confirm any communicable or infectious disease that the person is suspected to be suffering as observed during the clinical examination, if applicable. It should also indicate that “based on the medical examination, he/she is found free from any infectious or communicable diseases, and the person is fit to work in the food establishment.”
Discretionary Powers of Food Safety Officer vis-à-vis ordering medical examination of workers
If a Food Safety Officer, during an inspection, believes that the food handler is suffering from any infectious disease, he may ask for a medical examination of that person, and on such examination, if he finds out that person is suffering from an infectious disease, he has the authority to prohibit employees suffering from infectious diseases from participating in food handling activities and ensure strict adherence to health and safety.
Penalty for non-compliance
Failure to comply with these regulations can result in penalties of up to two lakh rupees and potential license cancellation under Section 58 of the Food Safety and Standards Act, 2006.
Conclusion
All FBOs should sensitize themselves to the legal requirements of annual medical examination of staff, mandatory vaccination of workers working in food factories, and general hygiene and sanitary requirements applicable to all persons handling food or operating in an area where food is handled. Failure to meet these requirements of food laws may result in a heavy monetary fine and suspension or cancellation of the license.
India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment. Source:bit.ly/4cgRsxK
India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes. Source:bit.ly/3RIc0XE
The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China. Source:bit.ly/3RF3xEH
India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes. Source:bit.ly/4bmOVR8
India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor. Source:bit.ly/3RHALDn
India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.
In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015. The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.
Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.
Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.
Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.
Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.
Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.
Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.
Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.
Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.
It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors. India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.
The import of medical devices including in-vitro medical devices (hereinafter referred to as “medical devices”) in India is regulated by India’s central medical device regulator, the Central Drugs Standard Control Organization (CDSCO). In order to import a medical device into India, the importer has to make an application for import license Form MD-14 of Medical Devices Rules,2017 (MDR, 2017) before CDSCO. Once the application is processed successfully, the CDSCO grants an import license to the importer in Form MD-15 of MDR, 2017.
For Class A and Class B medical devices: 1st October 2022
For Class C and Class D medical devices: 1st October 2023
In the paragraphs below, we have answered some of the common questions regarding timelines for obtaining import license for medical devices on the basis of our working knowledge of the law and prevailing practice.
1. What is the usual time within which an import licence may be granted by CDSCO?
The prescribed timeline for issuance of import license is nine (09) months from the date of application. However, the timeline is suspended if a query on the application is raised by CDSCO.
2. What is the approximate timeline for receiving query from CDSCO on the import license application?
As per current estimate, a query is typically received within a span of 3-4 months from the date of import license application. Please note that CDSCO may raise multiple rounds of queries.
3. How much time does an applicant of import license gets to reply to the queries?
The general expectation of CDSCO is that the queries should be responded within forty-five days from the date of receipt of queries.
4. What happens if a query cannot be responded within 45 days?
If the applicant is facing a difficulty in replying to the query, an intimation may be sent to CDSCO justifying the reason for delay and providing appropriate undertaking.
5. What is the maximum time within which queries have to be responded?
There is no official time limit for responding to the queries which has been stipulated by CDSCO. However, the expectation is to respond to the queries within the reasonable time frame.
6. What is the timeline by which the response to the queries is processed by CSDCO?
There is no prescribed timeline for processing the queries by CDSCO. However, the timeline for grant of import licence is nine (09) months from the date of filing of the application.
7. Is the time taken by the authorities to grant an import licence includes the time taken by the importer to respond to the queries?
No. The total timeline of nine months prescribed for grant of import license is not inclusive of the time taken by the importer to respond to the queries.
8. What is the time limit in which the importer can appeal to the Central Government in case the application is rejected by CSDCO?
If the application is rejected by CDSCO, the applicant may appeal to the Secretary, Ministry of Health and Family Welfare within a period of forty-five days. The Secretary or another officer designated by the Secretary may, after conducting an enquiry into the matter as considered necessary, pass orders in relation to the appeal within a period of ninety days from the date of appeal.
9. What is the validity of import license granted in Form MD-15?
The licence granted by CDSCO under Form MD-15 is valid in perpetuity unless cancelled or surrendered. The validity of the license so granted is subject to the payment of the retention fee by the importer.
10. When is importer license retention fee due to be paid?
The retention fee to retain import license has to be paid by the importer every 5 years.
11. What if the importer of medical device fails to pay the retention fee within the prescribed time period?
If the import licence holder fails to pay the required retention fee on or before the prescribed due date, the license holder is required to pay a late fee in addition to the retention fee.
The late fee will be calculated at the rate of two per cent (2%) of the import license retention fee for every month or part thereof within ninety days. Non-payment of fee until expiry of ninety days will result in cancellation of the import license.
All medical devices that are manufactured in India or are imported into India have to either be licensed or registered by October 1, 2021. If a medical device is manufactured or imported after October 1, 2021 without registration or license, it will be deemed to have been manufactured or imported in violation of Indian law, thereby inviting penal action.
As a background, until 2020, the Indian Government regulated 37 categories of medical devices (scroll down for list) under the Drugs and Cosmetics Act, 1940 (DCA) and Medical Devices Rules, 2017 (MDR) for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices.
In 2020, the Indian Government brought about a change in law to the effect that manufacturers and importers of all medical devices other than the 37 categories of medical devices have to obtain registration ‘voluntarily’ before October 1, 2021. Those manufacturers and importers who are unable to obtain registration before October 1, 2021 would have to either stop business of said medical devices till they obtain the requisite registration, or risk facing penal consequences of violating DCA and MDR.
With an intent to help and support medical devices companies who wish to obtain a registration, we have put together a list of frequently asked questions (FAQs) with our responses in this article.
Please note that these FAQs are based on our understanding of the law, and under no circumstances should they be regarded as legal or professional advice or an endorsement of any industry practice.
What is this new requirement for obtaining registration for medical devices and equipment?
Owing to an amendment to Medical Devices Rules, 2017 in February of 2020 (said amendment hereinafter referred to as “Medica Devices (Amendment) Rules, 2020” or “MDR 2020”), manufacturers and importers of all medical devices and equipment (with the exception of those that have been notified by the government) in India are required to register their medical devices in India before October 1, 2021.
The list of devices notified by the government, to which the requirement of registration does not apply, is reproduced at the end of these FAQs.
Is the registration requirement voluntary or mandatory?
As per MDR 2020, the enforcement of registration requirementis to begin from October 1, 2021. The government has given time to the medical device industry to register ‘voluntarily’ by October 1, 2021. After that, manufacturers and importers will have to ‘mandatorily’ register their medical devices and equipment in order to be able to manufacture in India or import medical devices into India.
How to obtain registration?
In order to obtain registration, the manufacturer or importer of a medical device or equipment has to register itself, its medical device or equipment as well as the manufacturing site with the Central Drugs Standards Control Organization (CDSCO).
The registration is successful once the file number is generated.
What is the objective behind registration requirement?
The Indian government’s objective behind imposing registration requirement appears to be phase-wise regulation of all medical devices.
The pre-requisite for obtaining registration is just the existence of a ISO 13485 certificate (quality management system for medical devices) issued by a certification body accredited with National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) to the manufacturer of medical devices. No safety or effectiveness data is required to be submitted for obtaining registration. The intent of the Indian Government appears to be to ensure that by October 1, 2021, all medical devices sold in India must be manufactured at a facility whose quality management systems meet the standards specified in the ISO 13485, as certified by an accredited certifying body.
Is there a list of medical devices available to which the registration requirement is applicable?
CDSCO has published a draft list of medical devices that may require registration. However, since this is only a draft list, there may be medical devices which are not part of the list but would still be subject to registration requirement.
In order to evaluate whether a product qualifies as medical device or not (and consequently would be subject to registration requirement or not), one may refer to the following definition of medical devices under MDR:
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception
If a device or equipment is covered by the definition of above, and it is not part of the list of devices specifically notified by the government (see bottom of the article for list), then such a device or equipment will be subject to registration requirement in India.
In certain cases, it may be helpful to avail expert advice in evaluating whether a product or equipment qualifies as a medical device under Indian law and is covered by registration requirement or not.
Whether components and accessories of medical devices are required to be registered?
Component and accessories of medical devices would be subject to registration requirement only if they qualify as medical device as per the definition of medical device i.e. if they are intended by their manufacturer to be used for medical purposes.
As per a recent clarification issued by CDSCO, components and accessories of medical devices imported as a system need not be registered separately. However, it is unclear what ‘separately’ implies, and why such an exemption should be given only to imported systems. It is our view that all components and accessories should be registered as part of the system because the official form for registration has fields under which details of components and accessories may be provided. In case components and accessories are not registered as part of the system for some reason, they should be registered separately, as components and accessories are ‘medical devices’ in their own right as per the definition of medical device.
In other words, components and accessories of medical devices may be registered alongside the system or independently, as long as they qualify as ‘medical device’ as per the definition of medical device.
What are the consequences of not obtaining registration before October 1, 2021?
A device to which registration requirement applies cannot be legally manufactured or imported into India without registration after October 1, 2021. The manufacturers and importers of such medical devices would have to obtain a registration for such devices in India before they can market these devices.
If a device is manufactured or imported after October 1, 2021 into India for marketing purposes without registration, then it would invite penal action under The Drugs and Cosmetics Act, 1940.
Who can make the application for registration?
An importer or manufacturer of the medical device or equipment can make the application for registration.
Can an importer obtain registration for imported medical device or equipment without whole sale drug license?
In order to create an account on the CDSCO’s registration portal as an importer, it is a pre-requisite to possess a whole sale drug license. However, for the time being, CDSCO is allowing registrations without a whole sale drug license as well.
What is the government fee payable for registration?
There is no government fee payable for registration.
What information is required to be provided for obtaining registration?
The following information has to be provided for obtaining registration:
Legal manufacturer’s name & address with Phone no., Fax & Email id,
Actual Site Details (Name, Address, Email ID, Fax No. & Contact No.)
Nature of activity (import/export)
Category of Device (medical device / IVD)
Generic Name, Model No.,
Intended Use,
Product Description,
Class of Medical Device
Medical Device Category
Grouping Category
Material of Construction,
Dimension (If any)
Shelf Life
Storage Condition,
Package Size,
Sterile or Non-Sterile,
Brand Name (If registered under the Trade Marks Act, 1999)
What are the documents required to be submitted obtain registration?
In addition to the information, the following documents are required to be submitted for registering a medical device: (1) an ISO 13485 certificate; (2) a Certificate to Foreign Government or Free Sale Certificate (for imported medical devices); and (3) an undertaking stating that the information and documents supplied are true and authentic are required to be submitted.
What is ISO 13485?
ISO 13485 is a standard for quality management system for designing and manufacturing a medical device.
Who issues ISO 13485 certificate?
ISO 13485 certificate is issued by a certifying body. For the purposes of registration, the ISO 13485 certificate must be issued by a certifying body accredited by National Accreditation Board for Certification Bodies in India or the International Accreditation Forum.
What is Free Sale Certificate or Certificate to Foreign Government?
A Free Sale Certificate or Certificate to Foreign Government is issued by a Regulatory Authority / Ministry of the country in which the medical device is approved and marketed. It serves as proof that the medical devices manufactured in the country as freely sold in that country (or region).
Is there a prescribed format for the undertaking to be submitted along with the application?
There is no prescribed format for the undertaking.
What are the compliances to be done after obtaining registration?
The registration number (file number) has to be declared on the label of the medical device.
How long does it take for the registration to be received once the application has been submitted?
After the application for registration is submitted, a file number is generated instantaneously. The generation of the file number concludes the process of registration.
What is the registration number?
The file registration number is the registration number.
Is the registration number different for different medical devices and equipment?
The registration number differs as per the manufacturing site. Different medical device and equipment manufactured at the same site will receive the same registration number. Same medical devices manufactured at different manufacturing sites will receive different registration numbers.
What happens if the applicant submits incorrect information?
Once incorrect information has been submitted, it can only be rectified by CDSCO. The CDSCO requires applicants to submit an undertaking at the time of submission of the application for registration that information contained in the application is true and accurate. Therefore, it is paramount that the information submitted as part of the registration application is true and accurate.
What is the penalty for submitting false information or documents?
The CDSCO may cancel full or part of the registration, effectively making it impossible to sell medical devices in question in India.
Is it possible to sell medical devices and equipment manufactured in India or imported into India before October 1, 2021 without registration?
Given past precedents in similar matters, it is likely that medical devices imported or manufactured before October 1, 2021 may be permitted to be sold in India without registration. However, no medical device imported or manufactured in India after October 1, 2021 may be sold in India if it is not registered and labelled with the registration number.
It will be easy for enforcement authorities to check whether a medical device or equipment has been manufactured or imported into India on or after October 1, 2021 because the Legal Metrology (Packaged Commodities) Regulations, 2011 require the all packaged commodities to contain either date of manufacture or date of import.
Is it possible to sell unregistered medical devices in India which have been manufactured or imported after October 1, 2021?
No. It will be violation of DCA and MDR if a manufacturer, importer or trader sells an unregistered medical device which is manufactured or imported into India on or after October 1, 2021.
In other words, the concerned manufacturer or importer will have to register its medical devices in order to manufacture or import medical devices after October 1, 2021 for sale in India. In such cases, the registration will no longer be “voluntary” but mandatory. The registration number will have to displayed on the label of such medical devices.
Will the process for obtaining registration change after October 1, 2021 when obtaining registration for medical devices and equipment is no longer voluntary?
It is our understanding that it will not change.
For how long is the registration valid?
The registration is valid until appropriate manufacturing or import license is obtained by the concerned manufacturer or importer for those devices.
Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of Class A (low-risk) and Class B (low-medium risk) medical devices will have to compulsorily obtain a license. Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of Class C (medium-high risk) and Class D (high risk) medical devices will have to compulsorily obtain a license. The CDSCO is in the process of undertaking risk classification of all medical devices.
List of medical devices that are not covered by registration requirement
The requirement to obtain registration does not apply to below categories of medical devices as these categories of medical devices are already regulated and require a license for manufacture, import, sale and distribution in India. In other words, if a manufacturer or importer has a license for manufacture or import of medical device, then registration requirement will not apply to such manufacturer or importer.
1. Disposable Hypodermic Syringes;
2. Disposable Hypodermic Needles;
3. Disposable Perfusion Sets;
4. Substances used for in vitro diagnosis including Blood Grouping Sera;
5. Cardiac Stents;
6. Drug Eluting Stents;
7. Catheters;
8. Intra Ocular Lenses;
9. I.V. Cannulae;
10. Bone Cements;
11. Heart Valves;
12. Scalp Vein Set;
13. Orthopedic Implants;
14. Internal Prosthetic Replacements;
15. Ablation Devices;
16. Ligatures, Sutures and Staplers;
17. Intra Uterine Devices (Cu-T)
18. Condoms;
19. Tubal Rings;
20. Surgical Dressings;
21. Umbilical tapes;
22. Blood/Blood Component Bags;
23. Organ Preservative Solution;
24. Nebulizer
25. Blood Pressure Monitoring Device
26. Glucometer
27. Digital Thermometer
28. All implantable medical devices Equipment
29. CT Scan Equipment
30. MRI Equipment
31. Defibrillators
32. PET Equipment
33. X-Ray Machine
34. Dialysis Machine
35. Bone marrow cell separator
36. Disinfectants and insecticide specified in Medical Devices Rules, 2017;
37. Ultrasound equipment (effective November 1, 2021)
Manufacturing drones [also referred to as Unmanned Aircraft System (UAS) or Remotely Piloted Aircraft System (RPAS)] in India is regulated by multiple laws including: Aircraft Act, 1934, Indian Wireless Telegraphy Act, 1933, Indian Telegraph Act, 1885 and Sea Customs Act, 1878 (as adopted by the Customs Act, 1962).
In this article, we have described the procedure that has to be followed for lawfully manufacturing drones in India.
Step 1- Obtaining Unique Authorization Number (UAN) for Manufacturer
Persons seeking to manufacture a drone have to first obtain a Unique Authorization Number (UAN) from the DGCA under the Unmanned Aircraft System Rules, 2021 (UAS Rules). It is important to note that only Indian citizens, enterprises (firms, partnerships etc.) and companies may seek authorization to manufacture drones.
Prior to making an application for authorization, the manufacturer has to first obtain security clearance from the Ministry of Civil Aviation (MCA) in consultation with Ministry of Home Affairs (MHA). The security clearance application may be made on the government portal https://e-sahaj.gov.in.
Upon receiving the security clearance, the manufacturer will have to submit an application to the DGCA in Form UA – 1 of UAS Rules along with the specified fee. The fee varies for each category of drone.
After the process of authorization is complete, the DGCA will provide a UAN for an authorized manufacturer. This UAN will be valid for a period of 10 years unless suspended, revoked or cancelled.
Any change thereafter to the credentials relevant to the eligibility criteria for obtaining the UAN has to be informed to the DGCA, and a fresh authorization will be issued thereafter if the eligibility conditions continue to be fulfilled.
Step 2 – Obtaining Equipment Type Approval for wireless system used in the Drone
An Equipment Type Approval (ETA) from the Wireless Planning & Coordination (WPC) Wing has to be obtained for every model and make of drone that is sought to be manufactured in India.
ETA can be obtained by making an application in the specified format to a Regional Licensing Officer (RLO) of the WPC Wing. The RLOs are located in Delhi, Mumbai, Kolkata, Chennai and Guwahati. An application form along with the technical literature, radio frequency reports from accredited labs and the requisite fees have to be submitted while applying for ETA.
An ETA issued for particular make and model of a prototype drone can be used by future users of the same make and model.
Step 3 – Obtaining Unique Prototype Identification Number
Any drone which has not been granted a Certificate Manufacture and Airworthiness (CMA) by DGCA cannot be used for sale and marketing purposes. In order to obtain a CMA, first a prototype of the drone has to be manufactured in India for testing at an approved laboratory.
In order to manufacture a prototype drone in India, the authorized manufacturer has to make an application for obtaining a Unique Prototype Identification Number, which is unique to the particular prototype drone and references the serial number. The application to obtain the Unique Prototype Identification Number has to be made as per Form UA – 2 of UAS Rules along with the specified fee.
The Unique Prototype Identification Number received from DCGA has to be affixed on the Prototype drone in an identifiable and visible manner.
Step 4 – Manufacturing a Prototype UAS
An authorized manufacturer can manufacture a prototype drone after obtaining the Unique Prototype Identification Number. The prototype drone is essential for the receiving the CMA.
Step 5 – Obtaining Certificate of Manufacture and Airworthiness (CMA)
Once the prototype drone has been manufactured in India, the authorized manufacturer is required to prove that the prototype drone is ‘airworthy’ i.e. it is capable of airborne operations as per the requirements stipulated by Indian law. A drone is considered to be airworthy only when it receives a Certificate of Manufacture and Airworthiness (CMA) from DGCA.
An authorized manufacturer can obtain a CMA by making an application under Form UA – 3 of UAS Rules to the DGCA with the specified fee. Please note that unmanned aircraft flight manual and maintenance manual should also be prepared and submitted along with Form UA – 3. On receipt of duly filled application, the DGCA allots an approved laboratory for testing of drones. Upon allotment, the authorized manufacturer has to submit the prototype drone which was manufactured in India along with design documents to the testing laboratory. The testing laboratory will test the prototype drone for its design, build and airworthiness. Once the testing laboratory validates the prototype drone and issues a test report, the DGCA will issue a CMA for specific type and class of a drone after being satisfied with the test report.
A drone can be lawfully manufactured in India after ensuring that the requirements stipulated in the steps mentioned above are complied with.
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