Both in terms of income and employment, the Indian healthcare industry has grown to be one of the country’s biggest industries. With a renewed focus from the government and rising market demand for healthcare services and goods, it has undergone fast development in recent years and grown noticeably more apparent during the previous ten years. India has over 800 manufacturers of pharmaceutical products and equipment, as well as its market is the fourth-largest in Asia. In this blog, we will discuss the importance of Medical Device Compliance.
The Indian healthcare market was worth $190 billion in 2020, and by 2024–2025, it is predicted to grow to $370 billion by the India Brand Equity Foundation. The industry’s quick growth is supported by large investments from new entrants supported by private equity investors as well as established corporate hospital chains. The operations of the state drug licencing bodies, policies, and consistent application of the act throughout India are primarily managed by the central drug standard control organisation (CDSCO), which is led by the Drug Controller General of India (Drug Controller General of India). The Act and its regulations aim to control the import, production, distribution, and sale of medical devices that have been notified. The state and central governments oversee the regulation of medical devices that have been notified. Therefore all the manufacturers must adhere rules of medical device compliance to smoothly run their business. With this there are few extra legal criteria for importing medical equipment into India. You must verify whether your product is regulated by the CDSCO before marketing it in India.
Regulatory Bodies for Medical Devices in India
The following two regulatory organisations are responsible for monitoring medical device compliance in India:
- Central Drugs Standard Control Organization (CDSCO)
The Central Drug Authority for carrying out duties delegated to the Central Government under the Drugs and Cosmetics Act is the Central Drugs Standard Control Organization (CDSCO). Seven laboratories, 13 port offices, six zonal offices, and four sub-zonal offices are all under the supervision of CDSCO.
The European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, and the National Medical Products Administration (NMPA) of China all perform similar functions.
The Central Drugs Standard Control Organization (CDSCO) was created by the Drugs and Cosmetics Act of 1940, and the Drugs Controller General of India (DCGI) is its principal regulatory body, acting on the recommendations of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
- Indian Council of Medical Research
One of the oldest and biggest medical research organisations in the world is the Indian Council of Medical Research, which serves as India’s top body for the formulation, coordination, and promotion of biomedical research. When it was established in 1911, its original name was Indian Research Fund Association (IRFA). IRFA changed its name to ICMR in 1949.
Medical Device Classification
The regulatory authorities have categorised medical devices based on their safety, effectiveness, and quality requirements. Medical equipment are categorised as follows:
- CLASS A: These medical equipment are regarded as low risk and are subject to broad restrictions. Examples include a toothbrush, a surgical tool, and examination gloves.
- CLASS B: The majority of the controls in this class are both generic and specialised controls. Compared to class 1, it needs additional regulatory oversight. These devices are considered to as low to medium risk ones. Examples include sterilised surgical gloves, tracheal tubes, stomach tubes, needles, and urine catheters.
- CLASS C: The notified body for the design and manufacture of medical equipment must certify CLASS C devices, often known as medium high-risk devices. Examples include condoms, anaesthetic equipment, non-absorbable sutures, blood bags, and contact lens care items.
- CLASS D: General and particular regulations with premarket authorization. The term “high risk medical equipment” is used to describe them. To assure their effectiveness and safety, these gadgets needed premarket clearance. Examples include angioplasty catheters, pacemakers, and vascular grafts. Implanted defibrillators, heart valves.
India’s Medical Device Quality Regulation
The Drugs & Cosmetics Act’s Section 3(b)(iv) mentions the word “medical devices.”
The quality and safety standards for medical devices in India are governed by the Drugs and Cosmetics Act of 1940. (DCA). Only medical devices that occasionally fall under the government’s definition of “drugs” are covered by the DCA (often referred to as “notified medical devices”).
In compliance with the Drugs and Cosmetics Act, the Medical Devices Rules of 2017 (MDR) were created. These rules establish strict quality requirements for those who create, import, manufacture, and sell medical devices that have been notified.
To ensure the quality and safety of medical devices at all points in the supply chain, the Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017 are in charge of enforcing a mandatory licence requirement. As a result, all importers, producers, and sellers of wearable medical devices must obtain a licence from the appropriate licencing body before engaging in any commerce.
Only after thorough evaluations and frequent inspections of the licence holder’s place of business is a licence awarded. A licence holder must also provide traceability in the case of a quality or safety issue by maintaining full records of all sales and purchases connected with notified medical devices.
Policy and Regulatory Environment for Medical Devices
In order to ensure patient safety and health, medical devices must be able to satisfy the criteria and be built in a specified way. The COVID-19 pandemic’s effects on India serve as a reminder of the value of making investments in the healthcare industry. Healthcare spending in India is expected to rise significantly over the next years, according to industry analysts, in part due to the lessons gained from the epidemic. With a particular focus on poor communities, the Indian government has proposed raising public expenditure on healthcare from its current level of barely 1.2 percent of GDP to 2.5 percent by 2025. The medical equipment market is expected to rise in lock step with rising healthcare spending in India.
37 medical gadgets are now covered under the Drugs and Cosmetics Act’s drug classification and regulation. Cardiovascular stents, drug-eluting stents, knee implants, condoms, and intrauterine devices are among those that fall under price controls and are listed on the National List of Essential Medicines. The Indian government began charging a 5% ad-valorem health tax in February 2020 on the importation of certain medical, dental, surgical, and veterinary devices. Several medical equipment categories that had previously been free from customs taxes (such as orthopaedic knee implants) were taken out of the duty exemption.
The Department for Promotion of Industry and Internal Trade modified its 2017 Public Procurement Order in June 2020 to give Indian businesses preference whose goods include at least 50% local content. Products having less than 20% local content are referred to as “non-local providers” and are unable to bid on public contracts.
The Trade Margin Rationalization (TMR) strategy, which is the distinction between the price at which manufacturers sell to the trade and the price to patients, was mandated by the National Pharmaceutical Pricing Authority with effect from June 2021. In order to promote patient access to inexpensive and accessible healthcare, the National Pharmaceutical Pricing Authority first implemented the Trade Margin Rationalization policy for medical equipment and medications in 2018.
The Indian Certification for Medical Devices Scheme of 2016 received new features in June 2021 from the Quality Council of India and the Association of Indian Medical Device Industry. This new programme, known as Indian Certification for Medical Equipment Plus (2021), was created to assist government organisations in spotting fake goods and certificates as well as to confirm the effectiveness, safety, and advantages of medical devices. The new regulations also did away with the requirement that manufacture and import permits be reapproved.
All medical device manufacturers must register their products with the Central Drugs Standard Control Organization in accordance with a mandated ISO 13485 certification, according to a notification the Indian government released in January 2022. The purpose of this criterion is to guarantee the secure manufacturing and management of in-vitro diagnostics and medical devices. Prior to this, there was a voluntary registration programme for medical equipment. Class A and Class B medical devices were subject to required registration beginning in October 2021, while Class C and D medical devices will be subject to mandatory registration beginning in September 2022. The medical device classes will switch to a licencing system after the required registration time ends in September 2023.
To guarantee patient access to essential medical technologies not currently produced in India, the Department of Pharmaceuticals revised the list of medical devices excluded from India’s Procurement Order 2017 in February 2022.
About Drugs and Cosmetic Act, 1940
Under chapter II – Drugs Technical Advisory Board, Central Drugs Laboratory and Drugs Consultative Committee
- Section 5 of the Drugs and Cosmetics Act, 1940 talks about the Drugs Technical Advisory Board.
- Section 6 of the Drugs and Cosmetics Act, 1940 talks about the Central Drugs Laboratory.
- Section 7 of the Drugs and Cosmetics Act, 1940 talks about the Drugs Consultative Committee.
- Section 7A of the Drugs and Cosmetics Act, 1940 talks about the Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.
Under chapter IV – Manufacture, sale and distribution of drugs and cosmetic
- Section 16 of the Drugs and Cosmetics Act, 1940 talks about the standards of quality.
- Section 17 of the Drugs and Cosmetics Act, 1940 talks about the misbranded drugs.
- Section 17A of the Drugs and Cosmetics Act, 1940 talks about the adulterated drugs.
- Section 17B of the Drugs and Cosmetics Act, 1940 talks about the spurious drugs.
- Section 17C of the Drugs and Cosmetics Act, 1940 talks about the misbranded cosmetics.
- Section 17D of the Drugs and Cosmetics Act, 1940 talks about the spurious cosmetics.
- Section 18 of the Drugs and Cosmetics Act, 1940 talks about the prohibition of manufacture and sale of certain drugs and cosmetics.
- Section 18A of the Drugs and Cosmetics Act, 1940 talks about the disclosure of the name of the manufacturer, etc.
- Section 18B of the Drugs and Cosmetics Act, 1940 talks about the maintenance of records and furnishing of information.
- Section 19 of the Drugs and Cosmetics Act, 1940 talks about the pleas.
- Section 20 of the Drugs and Cosmetics Act, 1940 talks about the government Analysts.
- Section 21 of the Drugs and Cosmetics Act, 1940 talks about the inspectors.
- Section 22 of the Drugs and Cosmetics Act, 1940 talks about the powers of Inspectors.
- Section 23 of the Drugs and Cosmetics Act, 1940 talks about the procedure of Inspectors
- Section 26A of the Drugs and Cosmetics Act, 1940 talks about the power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.
- Section 27 of the Drugs and Cosmetics Act, 1940 talks about the penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.
- Section 27A of the Drugs and Cosmetics Act, 1940 talks about the penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.
- Section 28 of the Drugs and Cosmetics Act, 1940 talks about the penalty for non-disclosure of the name of the manufacturer, etc.
- Section 28A of the Drugs and Cosmetics Act, 1940 talks about the penalty for not keeping documents, etc., and for non-disclosure of information.
- Section 28B of the Drugs and Cosmetics Act, 1940 talks about the penalty for manufacture, etc. of drugs or cosmetics in contravention of section 26A.
- Section 29 of the Drugs and Cosmetics Act, 1940 talks about the penalty for use of Government Analyst‘s report for advertising.
- Section 30 of the Drugs and Cosmetics Act, 1940 talks about the penalty for subsequent offences.
- Section 31 of the Drugs and Cosmetics Act, 1940 talks about the confiscation.
- Section 31A of the Drugs and Cosmetics Act, 1940 talks about the application of provisions to Government departments.
- Section 32 of the Drugs and Cosmetics Act, 1940 talks about the cognizance of offences.
- Section 32A of the Drugs and Cosmetics Act, 1940 talks about the power of Court to implead the manufacturer, etc.
- Section 33 of the Drugs and Cosmetics Act, 1940 talks about the power of Central Government to make rules.
Under chapter V – Miscellaneous
- Section 33P of the Drugs and Cosmetics Act, 1940 talks about the power to give directions.
- Section 34 of the Drugs and Cosmetics Act, 1940 talks about the offences by companies.
- Section 34A of the Drugs and Cosmetics Act, 1940 talks about the offences by Government departments.
- Section 34AA of the Drugs and Cosmetics Act, 1940 talks about the penalty vexatious search or seizure.
- Section 35 of the Drugs and Cosmetics Act, 1940 talks about the publication of sentences passed under this Act.
- Section 36 of the Drugs and Cosmetics Act, 1940 talks about the magistrate‘s power to impose enhanced penalties.
- Section 36A of the Drugs and Cosmetics Act, 1940 talks about the certain offences to be tried summarily.
- Section 37 of the Drugs and Cosmetics Act, 1940 talks about the protection of action taken in good faith.
- Section 38 of the Drugs and Cosmetics Act, 1940 talks about the rules to be laid before Parliament.
What are Medical Devices (Amendment) Rules, 2020?
All medical devices must be registered under The Drugs and Cosmetics Act of 1940 as of April 1, 2020, as a result of an amendment to the Indian law governing the quality and safety of medical devices that expanded the definition of a medical device beyond the 23 devices that had previously been notified.
Following are the effects of the legal change:
- All currently unregulated medical devices must be registered with the Drugs Controller General of India by their respective importers or makers prior to October 1, 2021. However, the obligation of registration does not apply to medical devices that are currently regulated or that have been warned to be regulated.
- Importers or producers of currently unregulated Class A (low risk) and Class B (low-medium risk) medical devices supplied in India will be required to get a licence before October 1, 2022.
- Manufacturers and importers of currently unregulated Class C (medium-high risk) and Class D (high risk) medical devices supplied in India will be required to get a licence before October 1, 2023.
- Importers and producers of medical devices must get ISO-13485 conformity certification in order to register their goods.
Purposes for Which CDSCO Registration Can Be Obtained
The Central Drug Standard Control Organization’s main goal is to provide CDSCO licencing guidelines that ensure:
- No animals are harmed or put through testing while making cosmetic items, nor are heavy metals and toxins used.
- The product is secure for general consumption.
- Only drugs and medical equipment that have received CDSCO approval may be imported.
The following are eligible for registration through CDSCO:
- Cosmetics Registration
- Import or Manufacture of drugs
- Export NOC (Zone)
- Test License
- Ethics Committee Registration
- Formulation R&D Organisation
- Blood Bank Registration
- Blood Product Registration
- Dual Use NOC (Trader)
- BA/BE Approved Sites
- Sponsors (BA/BE and CT)
ISO- 13485 for Medical Device Compliance
Registration of a Newly Notified Medical Device requires a certificate of Medical Device compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes). A certified manufacturer or importer of a medical device must always follow the requirements of ISO 13485. An independent audit must periodically make changes to the quality management system that is established, documented, and implemented in accordance with ISO 13485.
Importance of Medical Device Compliance
It is crucial for all manufacturers of medical devices to adhere to all medical device compliance requirements. Following points highlight the importance of medical device compliance:
- Medical devices must not harm those who use or operate them. Instead, they should enhance the health of the patient. Medical Device Compliance with MD regulations is essential to ensure that medical device is safe for the patients.
- Helps in smoothly audit of medical device in India;
- It also helps to regulate the pricing of some devices;
- To set the regulatory rules for the medical devices.
- Strict regulation allows patients to be compensated for harm caused by defected medical device.
- Uniform standards allow goods to be imported and exported without independent studies being required between countries.
- Apart from keeping non-compliant goods out of the market, it also encourages indigenous product development.
What Are The Ramifications Of Not Registering A Medical Device In India?
The importer or manufacturer of a medical device must stop importing or producing the device until the registration is obtained if they are unable to obtain one.
It will be simple for the DCGI or State-level Licensing Authority to identify whether a medical device is produced or imported illegally. Every maker and importer of a medical device (whether regulated or unregulated) is required to state the date of manufacturing or date of import on the item’s label in accordance with the Legal Metrology (Packaged Commodities) Rules, 2011, which came into effect in 2011. As a result, if a medical device’s label states that it was manufactured or imported on or after October 1, 2021, but the label is missing a DCGI registration number, the medical device will be seized by DCGI or the appropriate State-level Licensing Authorities, who will also take the necessary legal action against the manufacturer or importer. Criminal charges, which may include imprisonment and a fine, may be brought for any MDR infraction, including failing to register or obtain a licence prior to the deadline. Any stock of medical equipment sold without authorization or registration runs the risk of being seized as well.
The medical industry is expanding quickly due to rising middle-class incomes, rapid economic growth, and increased market penetration of health insurance providers. In addition, a rise in healthcare spending across the nation is a result of shifting demographics and a switch from chronic to lifestyle diseases. Any instrument, apparatus, appliance, software, or material used alone or in combination and intended for use in disease prevention and treatment (diagnosis) is referred to as a medical device. Despite the slowdown in the global economy, the Indian medical device industry is growing quickly.
Although they are an essential part of healthcare, medical devices are a remarkably diverse class of products. Based on their intended uses, they can be broadly divided into preventative care devices, assistive care devices, diagnostic devices, and therapeutic devices. The fourth-largest market for medical devices in Asia is found in India. To serve the patients with best medical device it is important for all the manufactures to adhere to the rules and regulations regarding medical device compliance. The Central Drugs Standards Control Organization in India regulates medical devices as drugs in accordance with the Medical Device Rules, 2017 that were enacted by the government under the Drugs and Cosmetics Act, 1940. (CDSCO).
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