Dear Reader, 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.
Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court has laid down the situations in which a patient’s claim for compensation due to medical negligence may be reduced on the grounds of pre-existing conditions. These are: First, when a latent condition of the patient has been unearthed; Second, when the negligence on the part of the wrongdoer re-activates a patient’s pre-existing condition that had subsided due to treatment; Third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and Fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the patient even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions. This rule is commonly referred to as the ‘egg-shell skull’ rule.
Revised penalty will apply, even if the offence took place before the penalty is revised: Supreme Court
India’s Supreme Court has held that a repealed provision will cease to operate from the date of repeal and the substituted provision will commence to operate from the date of its substitution. The Court was dealing with a matter involving the determination of penalty for loss of liquor in transit. The unamended rule, which existed at the time when the breach happened, provided for a penalty of four times the duty payable on liquor. The amended rule provided for a penalty equal to the duty payable on liquor. Since no additional guidance for the application of the amended rule was prescribed, the Supreme Court held that the amended penalty provision would apply.
Proceedings related to alcohol content in drugs under excise laws and drug laws can run concurrently: High Court
India’s Gujarat High Court has clarified that action under the Drugs & Cosmetics Act does not exempt an individual from prosecution if a case is made out under the Gujarat Prohibition Act, 1949. In this case, a pharmaceutical manufacturer had allegedly violated the State’s prohibition law by selling intoxicating substances as ayurvedic medicine and, therefore, was facing action against the excise laws as well as drug laws.
India’s Directorate General of Foreign Trade (DGFT) has notified the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA) through a trade notice. Earlier, country-wise quantitative restrictions (QR) were imposed on the import of IPA into India.
Used imported medical devices with a minimum shelf life of 5 years are not waste: Tribunal
India’s Hyderabad Bench of Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has held that used medical devices with a minimum residual life of 5 years or more are not e-waste or hazardous waste. In this matter, a hospital had imported used medical equipment for internal use but the Customs had seized the capital equipment on grounds that the used medical equipment qualified as hazardous waste under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016
Dear Reader, 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.
Delaycondonation should be evaluated based on reasons provided and not merits of case: Supreme Court In a recent decision, the Supreme Court held that in condoning delay for a filing for which limitation period has been stipulated under the Limitation Act, 1963, a Court should not base its decision on whether such delay has been condoned in a similar matter, evaluating delay on merits of the fact situation, but rather each delay should be evaluated on the grounds pleaded in the application for its condonation.
Source: bit.ly/49MllnH
Central Government to take strict action against non-compliance with quality maintenance in manufacture of fire-resistant fabrics raw material The Indian Central Government is intending to take stringent action against violators of the Bureau of Indian Standards (BIS) Quality Control Order for raw material used to manufacture fire-resistant fabric used in upholstery used in commercial spaces such as cinema halls, conference halls etc. Pursuant to issue of this Quality Control Order, only those raw material that have been certified by the BIS may be used in manufacture of commercial space upholstery. However, this Quality Control Order does not apply to upholstery used in households or those manufactured for export.
Source: bit.ly/4cKT4R3
Indian Government partners with Quality Council of India to improve services at Central Government run hospitals India’s Central Ministry of Health and Family Welfare has entered into a Memorandum of Understanding with the Quality Council of India, to help improve quality standards for healthcare delivery at government run hospitals and help the hospitals get accredited by the National Accreditation Body for Hospitals/ Laboratories.
Source: bit.ly/3Ub0ful
Pricesof imported Active Pharmaceutical Ingredient see sharp decline due to action against cartelized manufacturers Despite an increase in demand in the Indian domestic pharmaceutical manufacturing sector for Active Pharmaceutical Ingredients (APIs), indicated by a 39% increase in year-on-year imports, the price of APIs being imported from China and other countries has reduced significantly to pre-COVID levels. This reduction is suspected to be caused by breaking-down of manufacturing cartels. This reduction in prices of API signifies an increase in profit margins for Indian firms which have traditionally been depended on Chinese imports.
Source: bit.ly/43Qlo0d
ECHR holds that inaction against climate change may be considered violation of human rights The European Court of Human Rights has issued an award in favour of several Switzerland based petitioners who brought claims against their Government. The Court held that the European Convention on Human Rights envisages citizens right to be protected by their government against adverse effects of climate change. The petitioners had claimed that the inaction of the Swiss government and insufficient mitigation measures had caused a violation of the petitioners’ human rights, since such inaction by the government has increased their likelihood of dying of heat stroke. Source: bit.ly/3JbMLZ6
Dear Reader, 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.
EnvironmentalCompensation Guidelines for Plastic Waste Published India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic Waste Management Rules, 2016. The Producers, Importers, Brand Owners and Manufacturers of plastic packaging will have to pay environmental compensation (EC) for non-compliance with the marking or labelling requirements, non-registration on the Plastic Packaging Waste EPR portal, shortfall in EPR targets, non-filing of annual returns etc. EC would also be levied on the generators of waste for non-segregation of plastic packaging waste at source and littering. The environmental compensation will be higher (15 – 20%) than the EPR credit charges prevailing in the market to ensure that it acts as a deterrent. The guidelines also specify the minimum and maximum amount of environmental compensation to be levied for violations of specific provisions of the Plastic Waste Management Rules, 2016.
Source: bit.ly/3U6zhUJ
Importerof cosmetics inadvertently receives import registration for cosmetic product without applying for it India’s Central Regulatory Body for Cosmetics, The Central Drugs Standard Control Organization (CDSCO), recently cancelled the import registration certificate of an importer of cosmetics after it realized that it had inadvertently granted registration certificate even though the importer had not applied for it. CDSCO has attributed the mistake to some technical issues.
Source: bit.ly/3vNc0xQ
Hairtransplantation by doctor with M.B.B.S. degree only does not automatically result in negligence, if standard of care not compromised by doctor: National Consumer Commission India’s National Consumer Dispute Redressal Commission (NCDRC) in Hyderabad refuse to fasten liability for medical negligence on a Doctor with M.B.B.S, who had performed a hair transplant surgery. The NCDRC observed that the M.B.B.S. course syllabus includes study of the dermis, and that a doctor with a M.B.B.S. degree has the qualifications and expertise to undertake minor surgeries of dermis such as hair transplantation.
Source: bit.ly/3PWQBZN
Indianhospitals have started using Artificial Intelligence extensively: Report India’s major hospital chains have reportedly started using artificial intelligence (AI) for prediction, prevention, diagnosis, and personalized management. These hospital chains are also commercializing their AI solution by licensing it with smaller hospitals.
Source: bit.ly/43Ua6rF
FrenchGovernment decides to impose fines on patients if they miss appointment with doctors The French government has decided to impose a fine of five euro ($5.50) on patients who miss doctor appointments or cancel them with less than twenty-four hours’ notice. The Government homes that this initiative would free up missed appointments for other patients. It is reported that over 27 million doctor consultations go waste in France due to patient absences.
Source: bit.ly/49p7Iug
Dear Reader, 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.
Bodymassagers cannot be ‘sex toys’ just because they can have alternative use: High Court
In a recent ruling, the Bombay High Court has held that body massagers cannot be treated as ‘sex toys’ merely because they can be used for alternative purposes. While coming to this conclusion, the Court observed that it would be incorrect to classify massagers as items of objectionable description or as obscene figures in the absence of any substantial justification.
Homeopathypractitioners cannot present themselves as gynaecologist; amounts to medical negligence and deficiency in service: State Consumer Commission
The State Consumer Disputes Redressal Commission, Lucknow (SCDRC) has taken the view that cross-practicing of medicine by doctors trained in branches other than allopathy constitutes medical negligence and a deficiency in service. SCDRC imposed a compensation of Rs. 30 Lakhs on a city-based private nursing home and a homeopathy practitioner for medical negligence. The practitioner misrepresented herself as a gynaecologist, and prescribed allopathic medicines. The SCDRC held both the practitioner and the nursing home liable for their negligence and deficiency in service.
A leading ayurvedic Indian FMCG company has tendered an unconditional apology for its misleading advertisement to Supreme Court
Following a contempt notice on misleading advertisements and the issue of summons, the co-founders of a major ayurvedic FMCG company have tendered an unconditional apology for the company’s misleading advertising practices. The Supreme Court had directed that the co-founders of the company appear personally before the Court on the date of the next hearing.
Governmentproposes ban on 23 dangerous dog breeds in India
The Indian Government proposed a ban on 23 dog breeds in the country that are deemed “dangerous for human life” in an effort to address the growing number of dog attack cases. Additionally, the government has urged state governments to desist from granting licenses or permits for the sale and breeding of these dog breeds.
DraftResolution introduced by the UN General Assembly on Artificial Intelligence
The UN General Assembly adopted its first resolution on artificial intelligence (AI) to ensure the technology benefits all nations while respecting human rights and ensuring safety. Co-sponsored by 123 states, the resolution was adopted by consensus without a vote. Recently, the European Parliament has also taken steps to adopt the Artificial Intelligence Act, considered the world’s first comprehensive legal framework for AI.
Dear Reader, 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.
Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward. Source: bit.ly/3TEO74B
Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India. Source: bit.ly/3VsdCaQ
Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company. Source: bit.ly/3vu45VQ
Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided. In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity. Source: bit.ly/3vkn7hu
EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period. The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market. Source: bit.ly/3Vr9zeK
Dear Reader, 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.
State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers. Source: bit.ly/49VuNW0
Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport. Source: bit.ly/49zbUZ8
Dengue Vaccine Clinical Trials to start soon in India A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India. Source: bit.ly/49OyQ7b
Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment. Source: bit.ly/49X0H4H
Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates. Source: bit.ly/3Ih1MbA
Dear Reader, 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.
Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment. Source: bit.ly/42U33yI
Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India. Source: bit.ly/3TgHANw
Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details. Source: bit.ly/42T2IMR
Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country. Source: bit.ly/3wsyHHs
India Seeks to delay implementation of EU Carbon Emissions Limits India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production. Source: bit.ly/42S7DxH
Dear Reader, 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.
India’s new criminal law regime to take effect from July 1, 2024 The three criminal laws, namely, Bhartiya Nyaya Sanhita, Bhartiya Nagrik Suraksha Sanhita, Bharatiya Sakshya Adhiniyam that will replace the erstwhile the Indian Penal Code, 1860; Code of Criminal Procedure, 1898; and the Indian Evidence Act, 1872, respectively, will take effect from July 1, 2024. However, Section 106 (2) of the Bharatiya Nyaya Sanhita, 2023 which provides for punishment of “0-10 years” in “hit and run” cases, has been put on hold. Source:bit.ly/3P13RMz Source:bit.ly/3TbqvUU Source:bit.ly/3wxhexO
Cosmetic Importers in India who are not directly authorized by foreign manufacturer must submit annual statement of import to Cosmetics Regulator The Central Drugs Standard Control Organisation (CDSCO) has issued a circular reminding cosmetics importers who have obtained Import Registration Number (IRN) in Form Cos-4A, that is on the strength of prior import registration issued to an importer authorized by the foreign manufacturer, to provide annual statement of cosmetics imported in India from date of grant of IRN. The importers have also been advised to furnish details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details. Source: bit.ly/49L6bzl
Timeline for obtaining Standard Mark for sanitary napkins, baby diapers and reusable sanitary pad/napkins extended to 1st October. India’s Ministry of Textiles has extended the date of enforcement of Medical Textiles (Quality Control) Order, 2023 from 1st April to 1st October 2024. The said order requires that Foreign as well as Indian manufacturers of sanitary napkins, baby diapers and reusable sanitary pad/napkins to obtain a standard mark and label the products with a standard mark before the products are sold in India. Source:bit.ly/3IjAWiV
Inspection of food manufacturers/processors in non-mandatory classes should be completed within 15 days: India’s food regulator The Food Safety and Standards Authority of India (FSSAI) has issued an advisory to State Food Licensing Authorities for processing licensing applications of manufacturers of food categories which do not warrant mandatory inspection such as prepared foods, Indian sweets, egg and egg products, foodstuff intended for nutritional supplements. The FSSAI has advised that such applications should ideally be cleared without inspection, but if for some reason an inspection is deemed to be warranted, then such inspection should be concluded within 15 days from date when the application is marked for inspection. Source:bit.ly/3wwHNTN
Germany legalises private cultivation and recreational use of cannabis Germany has passed a law legalizing cultivation of up to three cannabis plants and for owning 25 grams of cannabis for private consumption. The law also permits establishment of cannabis clubs to facilitate consumption with a cap of 500 members. Germany has become ninth country to legalise private recreational use of cannabis. Source:bit.ly/3OSK6a3
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)
Stay updated about latest legal and regulatory
developments in the area of health by subscribing to our newsletter
If you wish to receive more such legal guides and
latest updates in your inbox, you can subscribe
to our newsletter.
First telephonic consultation is FREE! Call 022 48900222 / (+91) 22 48900222 or fill-in the form below to hear back from us.
