Terror of 10 MB, a cross-sectional study investigates the regulation to the prospective of medical device

Abstract

An instrument, apparatus, implement, machine, implant, in vitro reagent, a component part or accessory which Intended for use in diagnosis of disease or other condition, or in the cure, mitigation and treatment or prevention of disease is called medical devices. Medical devices under new rule classified as Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk) commemorating the notification of January 31, 2017 of Ministry of Health and Family Welfare which is conformity with Global Harmonisation Task Force framework. As per make in India program, the industry of medical devices is USD 5.2 billion and is contributing 4%–5% to the USD 96.7 billion Indian health-care industry. A total of 750–800 medical device manufacturers in India, an average investment of Rs 170–200 million and an average turnover of Rs 450–500 million. An online licensing portal of the Central Drugs Standard Control Organization (CDSCO) called “Sugam portal” has been launched on November 14, 2015, to file application and grant permission of registration exclusively for Medical Device CDSCO MD Online portal. By making the document submission easier, there are lot of challenges also present in “Sugam-online Portal.” One of the main challenges in Sugam Portal is that there is no provision to upload files greater than 10MB file size. The current study addresses the issues and challenges faced by medical device industry and regulators with their potential solutions and recommendations.

INTRODUCTION

In India, at present, only notified medical devices are regulated as drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945. In the first schedule of Rule 2 of MDR 2017 specified that the Class of medical devices shall be published on the Central Drugs Standard Control Organization (CDSCO) website and Central Licensing authority may notify addition, deletion in such list of medical devices from time to time. CDSCO has already displayed the list of medical devices with classification, which is dynamic in nature. As per Medical Device Rules (MDRs)[1] and Regulations, medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the first Schedule (i) low risk (Class A); (ii) low moderate risk (Class B); (iii) moderate high risk (Class C); and (iv) high risk (Class D). The manufacturers of medical devices as specified in the rules will be required to meet risk proportionate regulatory requirements based on the best international practices. The National Accreditation Board for Certification Bodies will assess their competence in terms of required human resources and other requirements as shown in Table 1.

Table 1.

Various stakeholders involve in medical device decision-making

Stakeholders	Role
CDSCO	Central licensing authority in whole of India
SLA	State Licensing Authority in the designated state
MOHFW	Ministry of health and family welfare’s in matters related to approval of new drugs including biopharmaceutical products and clinical trials

CDSCO: Central Drugs Standard Control Organization, SLA: State Licensing Authority, MOHFW: Ministry of Health and Family Welfare

Medical devices are to be granted which belongs to Class A, without audit of site. In these cases, self-certification of manufacturer needs to be submitted for issuing the license. However, conformance with quality management system checked by notified bodies and state licensing authority will issue the license to manufacture of medical devices (Class A and B). Central Licensing Authority is issuing license after inspection and compliance as per quality. Quality Management system along with ISO 13485 for manufacturing of Class C and Class D medical devices, Import and export of all medical devices is regulated by CDSCO.[2]

Approval of clinical investigation of medical devices (i.e., new devices) at par with international practices is governed by CDSCO under the separate provisions of MDR rule 2017.[2] The renewal of license is not required because as per the government notification, perpetual license is being given by CDCSO. These rules are found as a milestone for all stakeholders, i.e., innovators, manufacturers, providers, consumers, buyers, and regulators.[3] The simplicity and transparency create a trustworthy environment between the investors and regulators which will ensure best quality, safety, and efficacy of medical devices.[3]

MATERIALS AND METHODS

It was a cross-sectional questionnaire-based study carried out among various stakeholder including regulators and industry people. Three hundred stakeholders(300) participated in this study. The questionnaire was designed and tested among small groups for doing a pilot study. The modified questionnaire was given to all participants. The questionnaire having 25 important questions/comments was given to participants after explaining the purpose of the study. Any doubts regarding questionnaire were clarified by the investigators. Thirty minutes was given for filling the questionnaire. The response in terms of responders versus nonresponders, agree versus disagree, yes versus no was recorded and analyzed by descriptive statistics using Sigma Plot 14.0 (Systat Software, Inc., San Jose, USA).

Format of questionnaire as given below

As shown in Table 2, questionnaire related to medical device has been put the stakeholders for their responses on this important issue.

Table 2.

Questions related to new medical device rule - 2017 (Central Drugs Standard Control Organization)

Questions	Option 1	Option 2
Are you aware about MDR 2017?	Yes	No
MDR 2017 standard is easily available	Agree	Disagree
Do you have idea about MD grouping?	Yes	No
A person or organization who is not aware for ISO 13,485 can understand MDR 2017	Agree	Disagree
Management representative is required for MDR	True	False
QMS system is integral part of MDR 2017	True	False
Current MDR labeling is sufficient	Agree	Disagree
Clinical investigation is clearly defined in MDR	Yes	No
MD classification is done on the basis of risk	True	False
Are you satisfied with MDR rule?	Yes	No
Is MDR is based on schedule M?	Yes	No
All the MD concern persons are not aware about complete MDR standards	True	False
Does MDs have some serious adverse effects?	Yes	No
Price regulations on MDs by NPPA are industry favorable or not?	Yes	No
Whether current regulation of MDR supports the industry	Yes	No
Is document submission, process of MDR is handy	Yes	No
10 mb data space on www.cdscomdonline.gov.in portal is sufficient	True	False
Online payment system is little complex for all class MDs. Helpline support is very poor	True	False
There is no provision to make online payment for Class A and B devices	True	False
Provision for online application of FSC, market standing certificate and NOC is not available	True	False
Gamma sterilization facilities are very limited in India on technical background considering product and process performance qualification	Agree	Disagree
Personnel are involved in MDs are well trained and qualified	Yes	No
India is good in export of MD	Agree	Degree
Bridge courses to empower to manpower involved in MDs are utmost necessary	Yes	No
Government of India included MDs in its popular scheme in Ayushman Bharat	Yes	No

MDs: Medical devices, MDR: MD rule, CDSCO: Central Drugs Standard Control Organization, NOC: No objection certificate, QMS: Quality management system

RESULTS AND DISCUSSION

The United State Food Drugs Administration was the first regulatory body to publish guidelines on specific regulatory pathway for the approval of Medical Device in the year 1976. These rules were titled as “Medical Devices Rules 2017” and with time have they have been updated and improvised according to the requirements. Whereas in India, rules for MDRs 2017 has been published in 2017. The present study demonstrate current understanding of rules, emerging issues, and challenges as well as potential recommendations further enhance the awareness, usage, and diversification of medical devices.

Most of the stakeholders working in the field of medical devices have understanding of its rules and regulations. Approximately 80% of these stakeholders understand MDR 2017 very well. They have proper undertaking about accessibility of these regulations. Interestingly, about 96% stakeholders mentioned that these rules are easily available and can be access using website of CDSCO www.cdsco.gov.nic.in. To further understand their depth in such rules, we have asked them about grouping of medical devices. It was found that 34% of stakeholders were not aware about such grouping of medical devices [Figure 1]. The stakeholders welcomed the initiative of the government to make management representative is responsible for legal representative as per MDR 2017 and indispensable legal action against management representative if the products are found not of standard quality. Surprisingly, only 50% people were aware of this important enforcement [Figure 1]. World is witnessing many updated labeling systems and same is to be implanted in Medical Devices. About 15% people consider that there is a need for inclusion of barcode, identification mark, etc., for medical devices (Class C and Class D). In Medical Devices Rules 2017 classification on the risk based, i.e. Class A, Class B, Class C, and Class D [Figure 2].

Figure 1.

Responses of various stake holders on important questions related to Medical Devices and its regulations

Figure 2.

Responses of various stake holders on important questions related to Medical Devices and its regulations

As per MDR 2017, In vitro diagnostic shall be classified as:

• (1)Part I and Part II of the First Schedule on identified factors.
  • (i)
    Low risk (Class A); (ii) low moderate risk (Class B); (iii) moderate high risk (Class C); (iv) high risk (Class D).

Fifty-six percent of the stakeholders are not satisfied with the current MDR 2017 as amended by the Ministry of Health and Family Welfare because industry feels that there is requirement of separate medical devices bill with the changes of offence given in Drugs and Cosmetics Act 1940 [Figure 3]. As per the current regulation, industry feels that there is urgent need for price regulation, incentives/subsidy to the industry and well trained personnel in this field as 69% stakeholder have shown their concern for NPPA, 33% stakeholder feels Government should positive initiatives to support the industry in this field. 72% of stakeholders are feeling that there is a still need for trained people. As Ayushman Bharat scheme is being implemented in a big way, in which these industry can play major role that can be achieved by trained stakeholder and flourishing industry.

Figure 3.

Responses of various stake holders on important questions related to medical devices and its regulations

Although government of India has been taking several initiatives to facilitate the single window system for the industry; however, 97% stakeholder feels that the procedures are not very handy [Figure 2]. The limitations of documents size 10MB is critical concern and it is become a Terror of 10MB for the industry [Figure 2]. There is urgent need for making a suitable platform for system to accept the application in its original size without any limitation of space. If such initiatives are being taking care properly the medical devices industry will flourish. Such initiatives and incentives help industry to develop quality products and to export in the various countries and also make in INDIA campaign success as initiatives by Prime Minister of India.

As shown in Table 3, India has also introduced regulations as per majority of countries including the USA, UK, Japan, Singapore, and Canada in 2012. The majority of stakeholders agree with the opinion that entry of medical device is a welcome step from government and same can be considered as a boon for the patients undergoing life-threatening diseases.

Table 3.

Questionnaire to assess the perspective of medical device among various stakeholders including researchers, clinician, and industry people

Countries	Regulatory authority	Terminology	Year issued	Clinical trial/additional clinical	Major steps	Clinical data
US[4]	FDA	Follow on MD	1976[4]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, pivotal studies, postmarketing study, postsurveillance studies
UK[5]	EMA	MD	2017[5]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, postmarketing study, postsurveillance studies
India[6]	CDSCO and DBT	MD	2017[6]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, postmarketing study, postsurveillance studies
Canada[7]	Health Canada	Subsequent entry MD	1998[7]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, postmarketing study, postsurveillance studies
Singapore[8]	HSA	MD	2007[8]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, postmarketing study, postsurveillance studies
Japan[9]	PMDA	Follow on MD	2004[9]	Mandatory	Biocompatibility clinical investigation, analytical studies, animal trials, PMS	Study and efficacy and safety, postmarketing study, postsurveillance studies

FDA: Food drugs administration, EMA: European medicines agency, CDSCO: Central Drugs Standard Control Organization, MD: Medical device, PMDA: Pharmaceuticals and medical devices agency, HSA: Health sciences authority, DBT: Department of biotechnology, PMS: Post marketing surveillance

There is no doubt that medical device enhance the life span of patients. However, major stakeholders disagree that it can be better option from innovator product.

The study surface the limitation about the qualified personnel involves in medical device. As major people believe that there is lack of expertise in this field. The same can be achieved through government initiatives for bride courses which is also strongly felt by the major stakeholders participated in the study. Another important concern raised by participated was the affordability and pricing. There is no proper regulation for the pricing and market access. In addition, medical device is compared with approved product rather than innovator products which affect the quality. However, industry has further limitation of timeline of the product access to the market. Considering the data generation as per need of regulators is uphill task for industry. Industry is also raise the concern for single window approval system of medical device. As government giving export incentives in varied products, industry is advocating similar incentive to support the medical device production and export.[10]

CONCLUSIONS AND RECOMMENDATIONS

Medical devices show immense hope in the field of medicine because of their potential use and low cost than their original biologics. Although there are many countries that have not approved the use of Medical devices also, there are few countries that have issued regulatory guidelines for medical devices hesitate to accept in using them. Their nonacceptance is due to very low knowledge of the medical devices. This issue can be resolved by initiating new schemes that could educate patients and distributors about the efficacy and safety of the medical devices. Different countries have issued different set of guidelines with no common regulation worldwide. Countries should work toward setting a new common set of guidelines for the easy flow of trade. This would allow a uniform harmonization of a medical devices and their easy acceptance in different countries which would further help in fast treatment of a disease and easy availability and accessibility of the medicine to the patients. Government of India should come with a medical device bill for the betterment of the industry and people.

Following needed to be taken consideration for improving perceptions, enhance the perspective usage of medical devices through promulgation and implementation of rules and regulation for all the stakeholders: educate patients, professionals' about medical devices; make better marketing and pricing policies to ensure benefits to the manufactures and patients; assess patients' indifferent geographical locations through patent studies.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.