Journal of Biomedical Engineering and Medical Devices
Open Access

Comparative Regulatory Insight for Medical Device in India and EU

Nitika Agrahari^*, Divakar Goli and Shantha Kumar Gs ^*Correspondence: Dr. Nitika Agrahari, M. Pharm Drug Regulatory Affairs, Department of Pharmacy, Acharya & BM Reddy College of Pharmacy, Bengaluru-560107, India, Tel: +918003838674, Email:

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Introduction

Medical device is any instrument, implement, device, appliance, machine, implant, reagent for in-vitro use, material, software or other similar or related article, intended by the manufacturer to be used in combination or alone, for human beings, wherein the software required by its manufacturer is intended to be used exclusively for therapeutic/diagnostic purpose and vital for its proper application for one or more of the specific medical purpose(s) of:

A) Diagnosis, monitoring, preventing, alleviation or treatment of disease,

B) Examination, modification, support or replacement of the physiology process or anatomy,

C) Life sustaining or supporting or system,

D) Conception control [1].

India

In June 2005, CDSCO in India produced Medical Device guidelines and in Jan 2017, MOH notified through GSR. 78 (E) the separate guideline for “Medical Devices Rules, 2017” which came into force from 1st Jan 2018. Before implementing the Medical Device rules of the Medical Device Rules, ‘notified medical devices’ were considered as pharmaceutical drugs in India according to the Drug and Cosmetic Act, 1940. Hence, it was necessary to have separate guidelines for pharmaceutical drugs and medical devices [2].

Classification

In line with world rules and regulations, there are new rules which are introduced based on the risk the new rules for classification.

Medical Devices are classified by CDSCO and it will periodically publish the classified medical devices on website. To classify the medical devices the importers and manufactures should follow the below mentioned classification list (Table 1). If the medical device classification is in higher grade especially in GHFT countries here also it will be considered as higher grade medical devices.

Table 1: Classification of medical devices.

European Union

On 25 May 2017 the latest MD Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746 come into effect [3].This replaces the 3 Directives which is existing beginning from May 2020 (for mds) and from mid-2022 (for ivds). The producers were granted this transitional phase to conform to the current MD/IVD regulations (Table 2). Until the time as nbs have been assigned to certify against both the newly introduced regulations, all the mds must meet the important/essential requirements set out in the directives [4,5].

Table 2: Classification of medical device as per EUMDR.

Objectives:

• To review regulatory framework for import registration.

• Potential Impact of Medical Devices Regulation, 2017/745

• To compare the detail regulations of Medical Device in EU and India to address compliance.

Methodology

The research carried out with the collected data by analyzing the terms of the below parameters:

1. Internet using official web page

2. Overview of Regulatory Guidelines

3. Review and compilation of documents

Results

Medical device registration and import regulations in India

Registration procedure: In India, for the medical devices import, registration and import permits are essential. Therefore, an individual who is likely to import medical devices into India must obtain a certificate of registration and import permit. Both production and import license applications are dealing with thru an online portal, SUGAM— an online licensing program is part of the MoHFW.

SLA shall control the manufacturing authorization for products of Class A and B medical device, and the prerequisite for Class C and D licenses will be referred to the CLA. A Quality Assurance Report (QAR) of Class B, C and D goods must be published in accordance with manufacturing license; By comparison, a QAR for medical devices under Class A has to be issued within 4 months from the authorization date of the license for manufacture. In the event that products were not shipped into the nation before the date of the notification, the import is not authorized. The permission of the competent authority is needed for the importation of medical devices into India. Certain products that are already in use are placed introduced in the market for a certain period of time until the request made is denied or accepted [6].

Chapter 5 of the MDR 2017 deals with the import of medical devices for marketing and distributing in the Indian market. International manufacturers may select a competent Indian agent to carry out PMS operations and medical device delivery by holding the license. Any authorized agent who already had a license for manufacturing the medical devices for the purpose of distribution or sale may request for an import license shall be presented to the CLA for all classes of medical devices. Indeed, any wholesaler planning to produce medical devices for import must request for an import license. The mechanism for licensing is governed through MoHFW under central government. The ministry has an electronic database, from which the demand for an import license will be rendered. Use Form MD-14, the submission is submitted with the regional licensing authority (Table 3).

Table 3: List of document to be submitted with form MD 14.

As well, the individual is required to present several other documentation together with the verification form. First of all, the submission must have a cover letter in an appropriate template, and the application must have the correct details. In addition, the applicant may apply for a valid Indian medical device distributor wholesale/manufacturer permit. This is an essential condition for submitting a request. The purchaser always needs to present the submission with FSC. A certificate signifies the manufactured medical devices are openly available into the selling country's open market and are allowed for sale and trade globalization is said to be Free Sale Certification.

The supporting documentation often include standard certificates from international manufacturers guaranteeing good quality of the product being imported. A DMF that describes the importing medical device technological, health, and safety-related information and test data. The application should also include a PMF which describes specifics of the medical device's manufacturing process.

In India, there are many items requiring registration including spinal pins, heart valves, syringes, annuloplasty tubes, and needles, cardiac stents, cochlear implants, catheters, etc. Any business company that wants to license or import medical devices lawfully into India must abide by the rules laid down in the New Medical Device Regulation 2017 of CDSCO. In case, in India, there is no registered office of the organization, then the organization will need to appoint an "authorized agent" to manage the registration processes and other functions (Figure 1). An "authorized agent" is the one who have a very important role in the registration process and is also authorize for the follow-up actions [7,8].

Figure 1: Process of obtaining registration.

1. Business activity

2. PMS

3. Pre-certification.

Medical devices import procedure in India

A list of documentation is required for importation of medical devices to be submitted with Form MD 14 (Figure 2).

Figure 2: Application for import license via SUGAM portal.

Registration certificates

The 2017 Rules also eliminated the need for a certificate of approval to recognize an international manufacturer its location and the goods. Presently we have to make two separate applications to import and marketing products in India (registration and import license) (Table 4). The international distributor shall designate an authorized agent in India after the start of the Rules 2017 and is applied to get import license to get imported and marketed devices into the nation. After 9 months the claimant will be issued an import permit (Table 5).

Table 4: Timeline to obtain manufacturing/import license for medical device.

Table 5: Potential impact of medical devices regulation, 2017/745.

In India, renewal process for certificates is far less rigorous when compared to other countries (Supplementary Table 1). For retaining certificate's permanent validity, the applicant should incur an annual renewal, maintenance charge of Rupees 20,000 (about $310) every 5 from years from the issuance date [9-15].

Discussion and Conclusion

The changes made by Medical Devices Rules 2017 are anticipated to allow more multinational companies (MNC) to build manufacturing facilities for medical devices in

1. From this research project it is inferred that no such strict regulations and rules for the import, production, and selling of medical devices existed till 2017.

2. The approved medical devices need to carry unique device identifiers by 2020. Medical devices licensed for manufacture, selling or delivery in India shall carry two different types of unique identifiers, beginning on January 1st, 2022 to ensure safety and effectiveness, the government is setting up research labs in the country to address shortcomings in medical device goods.

3. Nonetheless, some analysts do believe that the strict regulations will contribute to delays in securing the approval of CE mark and leads to a significant decline in the number of ground breaking CE marked MDs. The EU MDR is projected to dramatically alter MD manufacturers ' activities and even affect the structure of both their current and prospective portfolios.

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