FAQ

Yes. Under the provision of Drugs and Cosmetic act 1940, cdsco registration and import license is required to import Medical Devices in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of India. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices as per cdsco guidelines are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in India. When the Medical Device released to be imported it has some issued steps to be followed. Only those medical devices require import license which are listed in Notified medical devices by CDSCO.

For the licensing is regulated by the ministry of health and family welfare in the central government. The ministry has verified the CDSCO registration online portal through which the import license has to be made. The application is made to the central licensing authority using Form MD-14. The applicant should also submit some other documents along with the application Form for verification. Firstly the application must have a cover letter in a proper format having proper details for the application. The applicant needs to submit a valid manufacturer license of Indian agent for medical devices. This is the important condition for filling an application.

Primary packaging material license is not a requirement for its manufacturers in India. However adhering to regulatory standards it is essential for a pp mfg to have Type III DMF for USFDA and ISO 15378 standard certification. Hence having Quality system in place for the manufacturing unit eases the export of primary packaging product to various countries.

Operon Strategist provides primary packaging consulting services to manufacturers for ISO 15378 certification and prepare Type III DMF. Our team ensures the system has adequate procedures in place to face the audits from the auditing bodies. Also we train the employees according to the procedures.

A medical device is device or a equipment used for medical purposes. Medical devices help patients, by health care providers diagnose and treat patients and help them overcome their sickness or disease. Important potential for dangers are basic when using a device for medical purposes and hence medical devices must be proved safe and effectual with reasonable assurance before regulating governments allow marketing of the device in the country. Medical devices differs in both their purposeful use and indications for use. For example range from simple low risk devices such as Thermometers, medical Gloves, Bedpans to complex, high risk devices which are implanted and support life.

Primary Packaging materials are used in the pharmaceutical industry. The packaging ensures the protection of the drug during sale. Objectives of packaging are containment, Physical and Chemical protected, Portion control and security of the drug. Packaging in the Pharmaceutical Packaging are at different levels, Primary, Secondary, and Territory. Primary Packaging is also known as sales Packaging. Primary Packaging is of great importance in the pharmaceutical industries Primary Packaging comes in direct contact with the products itself and sometimes is introduced as consumer or retailed packaging. Primary Packaging is like a package that holds or is wrapped onto your products or medicines, the packaging is usually not removed until the product or medicine is not used. Primary packaging should strengthen the benefits and appearance. Benefits are important because if the packaging is defective it may direct impact the users capability to use the product. We provide complete Primary Packaging consulting services that include support for manufacturing facility, DMF preperation and getting the ISO certifications.

IEC (Import Export Code)

It is the first requirement you before you start an import/export in India. An IEC is important for the import and export of goods. The IEC is issued by the Directorate General of Foreign Trade (DGFT) Ministries of Commerce and Government of India.

Medical Device Import License.

Importer of Medical Device has to adhere to various rules set by the national regulatory bodies of India. The main regulatory body of India is Central Drugs Standard Control Organization (CDSCO). A License is issued by CDSCO after examining various documents of Manufacturer of Medical Devices outside India and importer from India

After analysing of the documents with the applications under the rule

[1]rule of 34 on the basis of inspection report if the inspection has been carried out the central licensing authority may, on be satisfied and grant license in Form MD-15 or may reject such application for which reasons shall be recorded in writing, within a period of 9 months from the date of application.

[2] if the license gets rejected, the applicant can appeal to the central government within the period of forty to fifty days and that government may after such enquiries into the matter are considered necessary pass orders in relation there to within the period of ninety days from the date of appeal

[3]Where a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competing authority of any of the countries namely Australia, Canada, Japan, European Union Countries, or the United States of America, a license shall be granted under sub rule [1] to the applicant without carrying out any investigation.

[4]Where a medical device is imported from countries other than those referred to in sub-rule [3] the license in case of class c and class d medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India.

In order to market medical devices in the European Union, the CE certification is needed . This certification states that the devices meets to all the regulatory requirements of the Medical Devices Directive [MDD].

The process for the approval of Medical Device in Europe is

Classification of the Medical Devices based on the MDD guidelines.

• For all Classes Is II and III except class I non (non sterile, non measuring) implement Quality Management System (QMS) accordance to Annex II or V of the MDD

Most of the companies apply for the ISO 13458 standard to achieve the QMS compliance.

• For class I non (non sterile, non measuring) QMS is not formally required. However a PMS procedure is required, though not audited by Notified Bodies.

Medical Device Directives(MDD) are the guidelines for CE Marking which after 2020 will be replaced with Medical Device Regulation.(MDR). Please read here to know more

Medical Devices are generally based on Risk. The actual risk classification of each medical device depends on its intended use and purpose.

Classification of medical devices under the new rule of “Medical Devices Rules 2017” are classified as

• Low Risk – Class A – (Surgical Retractors, Tongue Depressors)
• Low Moderate Risk – Class B – (Hypodermic Needles, Suction equipment)
• Moderate High Risk ­– Class C – ( Lung Ventilator, Bone Fixation Plate)
• High Risk – Class D – (Heart Valves, Implantable Defibrillator)

A 510K is a Premarket Submission made to FDA to state that the medical device which is to be marketed is at least as safe and effectual that is considerably equal to a legally marketed device that is not subject to PMA. A PMA is a premarket approval it is the process of scientific and regulatory review analyse the safety and effectiveness of Class III medical device the applicant must receive the FDA approval of its PMA application prior to the marketing the device. Companies doing 510k submissions have to compare their devices to one or more legally marketed devices and make and support their substantial equivalence claims. A lawfully marketed device is a device that has been legally marketed or a device that has been reclassified from Class III to Class II or Class I SE through the 510k process, or else a device that was granted marketing authorization.

Drug Master File (DMF) is a document prepared by a pharmaceutical manufacturer and submitted solely at its caution to the appropriate regulatory authority in the conscious drug market. A DMF is a submission to the food and drug administration (FDA) that may be used to provide confidential information about facilities. There is no regulatory requirement to file a DMF. But the document provides the regulatory authority with confidential and detailed information about facilities, processes, or articles used in the manufacturing packaging, processing, storing of one or more human drugs. Basically a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product or a pharmaceutical industry. The DMF filing allows a firm to protect its conceptual property from its partner while observing with regulatory requirements for disclosure of processing details.

A technical file includes drawings, reports, review reports, specifications, meeting minutes, labels, instructions for use, software source code etc. Annex II of EU medical device regulation contains an overview of the contents and structure of a technical file. Technical file is a set of documents that describes a product and can prove that the product was designed according to the requirements of the Quality Management System. A CE marking technical file or design dossier Class III is a comprehensive description of your device intended to demonstrate compliance with European requirements. All products that have CE marking process must have a technical file which must contain the information the proves that the product conforms with the EU directives with the CE marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Medical Device Regulation (MDR) manufacturers need to maintain a MDR technical documentation as an evidence of conformity with the relevant legislation. Customers usually do not have the access to the technical file. A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in a electronic files.

Design Control labels the implementation of a formalistic technique to the ways of product development activities. It is often necessary by regulation for the appliance of such practice when designing and developing products within regulated industries e.g. medical devices. The Food and Drug Administration FDA has stated that medical device manufacturers that want to marketise certain classifications of medical devices in the USA follow design control requirements (21 CFR 820.30). Few firms regard Risk Management and Design Control as they are linked together but they follow separate procedures, not actualizing that the relation between the user needs, design inputs, dangers and dangerous circumstances. Design control conditions that when the suppliers or manufacturers get a product to design controls they may discover and maintain the correct documentation to assure the specified design requirements are.

A clean room plays a main and very important role in the productivity and features of medical device manufacturing. A clean room is a constrained environment that has a low level of impurities such as dust, airborne microbes, aerosol particles and chemical vapour. Clean rooms go through wide training in pollutants control theory. They come and go in the cleanroom through airlocks, air showers, or gowning rooms and they must wear unique clothes designed to trap the pollutants that are usually produced by body and skin. Relying upon the cleanroom classifications personnel gowning should be limited as the laboratory coats and hairnets, or as broad as fully covered in the number of layered bunny suits with separate breathing equipment. Clean rooms generate coarse free air with the use of HEPA filter applying laminar or turbulent airflow principles. Perfect clean room design surrounds the whole air dispensation system, with the necessities for acceptable, downstream air returns. Depending upon how clean the air is clean rooms are classified. The clean room classification standards FS 209E and ISO 14644-4 need specific crumb count and amounts and calculations to classify the cleanliness level of clean room and clean area.

ISO 13485 is the worldwide acknowledged standard by the International Standards Organization for medical device Quality Management System. The standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high-quality medical devices that reach up to customers and regulatory requirements. ISO 13485 can be used by any company involved in the transfer of medical devices, providing, support phases.) Furthermore, it can also be used by external or internal auditors to support the inclusive audit process. No, it is not a mandatory requirement for CDSCO manufacturing license.

A clean room is a laboratory faculty generally used as a part of expertise industrial production or for scientific research which includes manufacturing of pharmaceutical items. Clean rooms are designed to control extremely low levels of particles such as pollutants, dust, etc. Clean rooms undergo a broad training of contaminants control theory. Clean room has a clean level of measured by the number of particles per square meter. For the clean room FS 209 E and ISO 14644 classifications are referred for Quality purposes. Clean rooms have to control a particular free air with the help of HEPA filters. Airflow principles generally employ around 80% of clean room ceiling to manage constant airflow.

Clean rooms are classified depending upon the cleanliness of the air in the rooms. Clean room classes are the amount of cleanliness the room follows with, as per the size and amount of particles per volume of the air. Clean rooms are laboratory facilities used for industrial production used for manufacturing of the medical or pharmaceutical items.

Classes required for Clean room

ISO – 5 – 100

ISO – 6 – 1000

ISO – 7 – 10000

ISO – 8 – 100000

ISO – 9 – 1000000

WHO:- The World Health Association is a particular organization of the assembled countries that are concerned about international public health. The WHO is a member of the united nations development group. Its antecedent, the health Association was an agency of the league of nations.

cGMP:- cGMP states to the Current Good Manufacturing Practices guidelines authorized by FDA regulations. cGMP accommodates frameworks that guarantee proper design monitoring, checking, control of manufacturing procedures and facilities. Adherence to the cGMP guidelines that guarantee identity, quality, strength, and control. GMP certification is the term perceived worldwide for the control and the management of manufacturing, testing and general quality control of food and pharmaceutical products.

Before the introduction of a new medical device in the Indian market, the manufacturer has to accept certain regulations. If a sole person wants to import a new medical device, a license for the manufacturer of the product is necessary. The Central Drugs Standard Control Organization known as the (CDSCO) is a regulatory body, for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & 1945. CDSCO is the national regulatory body for Indian medical device industries and pharmaceutical industries. It is the licensing authority which approves any new medical device import to India. The Indian CDSCO is controlled and governed by Directorate General of Health Services which comes under the ministry of health and family wealth government of India. The CDSCO regulations are responsible for the registration and sale of notified medical devices in India.

ISO: ISO 13485 is the worldwide acknowledged standard by the International Standards Organization for medical device Quality Management System. The standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high-quality medical devices that reach up to customers and regulatory requirements. ISO 13485 can be used by any company involved in the transfer of medical devices, providing, support phases. Furthermore, it can also be used by external or internal auditors to support the inclusive audit process.

21 CFR Part 820: FDA 21 CFR Part 820: covers up the process used in & the facilities and controls used for the design, manufacture, packaging, labelling, storage, installation, & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820 & only compliance with the requirements is assessed. FDA 21 CFR known as the Quality System Regulation QSR acknowledges Current Good Manufacturing Practices CGMP regulations that govern the methods used in and the services, and controls used for, the design, manufacturing, packaging, labelling, storage, installation and servicing for all finished devices willful for human use. These requirements are necessary to ensure that medical devices are safe and effective for use. Medical device manufacturers undergo FDA inspections to assure FDA 21 CFR 820 agreement.

To launch a medical device, the manufacturer has to adhere to numerous norms set by way of the countrywide regulatory bodies of India. The number one regulatory frame for medical devices in India is the central drugs trendy control organization (CDSCO). The applications for all elegance of scientific gadgets are made to the important licensing Authority (CLA) in which the Drug Controller General of India (DCGI) takes obligation for the approval of manufacturing, registration, import, and sale of medical devices in India. The medical devices might also or won’t want to be registered before the sale. While there may be no want for registration, the producer must gain a no-objection certificate (NOC) from the DCGI before releasing the product inside the marketplace. Whilst the medical device to be launched is imported, it has a fixed of issued steps to be observed like filling of a registration form at the side of the fees. The form will include the applicant’s and manufacturer’s details, product facts, the regulatory fame of the product, info of good manufacturing practices included, and publish-marketing surveillance at the side of an assignment shape. The retailers, stockiest, and importers shall also gain the respective sale licenses from the nation Licensing government (SLA). The nation Licensing Authority is responsible for the control and enforcement of regulations related to the sale, stock, providing on the market of medical devices in India.

Medical Device Manufacturing in India :
There is the national regulatory body like CDSCO for Indian medical devices and pharmaceuticals, it is the licensing authority. The role of CDSCO is to provide the approval to any new medical device which is in the process to be imported to India. Within CDSCO, Drug Controller General of India (DCGI) is the final authority and controls medical devices and pharmaceuticals. Drug Controller General of India is in charge of endorsement of licenses of particular categories of Drugs such as IV-Fluids, blood and blood products, Vaccines and all medical devices. The Medical device manufacturing process is classified and categorized under the CDSCO guideline. “Those medical devices fall under Class A – Class B – Class C – and Class D according to their risk factors.

Medical Devices Manufacturing in the US
Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The medical devices fall under Class I, Class II & Class III.

MDSAP gives access for a manufacturer to register medical devices in five countries with one quality management system as implemented as per MDSAP. Five countries USA, Japan, Brazil, Canada and Japan. The Medical Device Single Audit Program – or MDSAP – permits a single regulatory audit of a medical device producer’s quality management system to fulfill the requirements of various regulatory authorities (RAs). MDSAP was created by the International Medical Device Regulators Forum (IMDRF) to address the fast development that has brought about increasingly advanced devices that require more prominent controller ability to screen. MDSAP likewise addresses the detonating worldwide exchange the medical device part. Its objective for building up a solitary review model was to advance more prominent arrangement and adaptable utilization of administrative assets through work-sharing and common acknowledgement among controllers while regarding the sway of every power.

No. MDSAP is acceptable in five countries, USA, Japan, Brazil, Canada and Japan. Rest of the countries have separate QMS requirements like ISO 13485 for EU countries

The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of health and ageing, supervises medical device regulation in Australia. Enrolling your device with the TGA involves risk based characterization; consistence with quality safety execution and standards consistence with regulatory control for manufacturing forms; posting in the Australian Register of Therapeutic Goods; and post-showcase cautiousness programs. Gadgets that have just earned CE certification from European Notified Bodies can all the more effectively validate adjustment to TGA requirements. Producers should likewise give Declarations of Conformity to the Australian Regulations so as to enroll with the TGA.

The Medical Device Single Audit Program (MDSAP) is a global initiative intended to accelerate medical device regulation harmonization by allowing a single regulatory audit to satisfy the requirements of multiple jurisdictions around the world

There are 3 steps to prepare for the MDSAP:

1) Conduct a Gap Assessment of all Standard Operating Procedures (SOP’s) and processes

Every manufacturer struggles to understand and adapt their processes when design control requirements were formally introduced during the switch from GMP’s to QSR’s, the MDSAP presents a similar learning curve with the introduction of risk requirements.

The MDSAP follows in line with a greater movement toward a more risk-based approach around the world. This program expands the definition of “risk” beyond risk assessments for products alone to encompass the entire quality system.

2) Develop and Implement a Comprehensive Risk Assessment Program

Regulators now expect manufacturers to conduct risk assessments on processes throughout the quality system. In particular, your Notified Body will be looking for a robust risk assessment program in order to gauge and measure your investment in assessing risk beyond product quality and safety alone.

In many cases, developing such a program will require companies either augment their current Quality staff or use a third-party consultant. In this case, an experienced consultant can bring firsthand knowledge gained through working with other manufacturers to build a program proven to be effective and aligned with regulatory expectations.

It’s important to note that the concept of risk still remains a tripping point for many regulated manufacturers. Given its recently-expanded scope, even veteran Quality professionals at the helm of smaller risk assessment programs struggle to know where to start when widening these efforts to the entire quality system.

Experienced third party experts are especially valuable not only for developing effective programs but prioritizing their implementation and ensuring sufficient documentation while training staff to successfully use the expanded program.

3) Ensure employees aren’t just trained in ISO 13485:2016, but fully “competent” in it

In addition to conducting a thorough gap assessment and developing a comprehensive risk assessment program, device companies that haven’t yet trained their employees to the ISO 13485:2016 standard should ensure they do so in preparation for the MDSAP.

This updated standard aligns incredibly closely to FDA’s regulations and an effective training program will prepare staff for the expectations that are quickly approaching.

Companies with robust FDA quality systems shouldn’t find the new ISO standard a considerable challenge beyond the new areas of risk-related requirements. Many industry experts predict the next version of FDA’s QSR will make risk its primary focus, in keeping with the broader trend seen throughout the world. As such, device manufacturers should make risk their primary focus as well.

Perhaps even more importantly, device companies must expand their concept of training beyond what was accepted in the past. One term in particular sets the bar for training much higher in the updated standard: competence.