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Medical Devices Rules, 2017

What are Medical Devices?

The Standards of quality and safety of Medical Devices are regulated by an Act known as the Drugs and Cosmetics Act, 1940. It should be noted that the Drugs and Cosmetics Act,1940 is restricted to those medical devices which are notified by the central government from time to time as “drugs”.  The Medical device rules, 2017 have been framed under the Drugs and Cosmetics Act, 1940. The Medical Device rules applicable on the marketers/ manufacturers/ importers/ sellers of medical devices.  The Medical Devices Rules 2017 comprises 12 chapters, 8 schedules.

The term medical device has been defined under section 2(zb) of the Medical Device Rules, 2017. It shall include the following specific devices:

·         That help in diagnosis and treatment, specific substances that affect the human body,

·         Surgical dressings, bandages, blood collection bags etc. or

·        Any other substance or device used in diagnosis or treatment of any disease or disorder of any human being or an animal.

These devices and substances defined under the rules will be notified by the government from time to time.

 

What is the procedure to obtain a Medical Device License in India?

The procedure for Registration of Medical Devices as given under:

1.  If any person wants to manufacture, Import, sell or distribute medical devices then he should apply for the registration of his device under the Drugs and Cosmetics Act, 1940. It should be noted that under the certain circumstances Drugs Controller General of India has the right to review the certain product and may grant the exemption.  

2.      In case of foreign manufacturers, it is important to appoint the Indian Authorized agent who can interact with the officials of the Central Drugs Standards Control Organization (CDSCO). That authorized agent must have a wholesale license and have a power of attorney.

3.      The medical devices which fall under the category of Class B, C and D are required to do performance testing through the Indian Lab or National Institute of Biological.

4.      Application form must include the details like manufacturing facility information, testing results, clinical data, ISO-13485 certificate and technical details of the device.

5.      Complete documents (in English) and application should be filed before the Central Drugs Standard Control Organization and pay the applicable fees.

6.      The Central Drugs Standards Control Organization reviews applications and may ask for a technical presentation, in which the product is discussed in detail.

7.      Then lastly Central Drugs Standards Control Organization will grant the certificate to the manufacturer/Importer/Distributor/ seller as the case may be.


What kind of documents are to be submitted?

Any person interested in acquiring the license of a medical device needs to submit the following documents before the authority.

·         Form 40

·         TR6 Challan

·         Plant Master File

·         Device Master File

·         Power of Attorney

·         Schedule D(1)

·         Quality Assurance Certificate

·         Declaration of Conformity

·         CE Design Certificate

·         ISO 13485 Certificate

·         Certificate of marketability from Global Harmonization Task Force (GHTF)

·         Free Sale Certificate

The above documents requirements depend upon product-to-product basis. Our professionals will guide you in preparation of documentation and will help you to achieve maximum comfort in difficult areas of the compliance requirements of the application.

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What is the classification of Medical Devices?

S.NO

Class of Medical Device

Risk Associated with Class

Licensing Authority

Devices Examples

1.

Class A

Low Risk

Drugs Controller General of India(DGCI) in case of Import and State-Level Licensing Authority in case of Manufacture

Thermometers/Tongue Depressors

2.

Class B

Low Moderate Risk

Drugs Controller General of India(DGCI) in case of Import and State-Level Licensing Authority in case of Manufacture

Hypodermic needles/suction equipment

3.

Class C

Moderate High Risk

Drugs Controller General of India(DGCI) in case of Import and Manufacture

Lung ventilators/Bone fixation plate

4.

Class D

High Risk

Drugs Controller General of India (DGCI) in case of Import and Manufacture.

Heart Valves/implantable defibrillator

The medical devices rules classify medical devices on the basis of risk associated with the device, as is done by the global harmonization task force. The Medical device classifies in four categories given below:

What is the validity of Medical Devices registration?

Import Licenses do not expire, so long as listing fees are paid every 5 years.

Relaxation from Obtaining the Medical Device License

The Central Government has given some relief from obtaining the registration and license for newly notified medical devices for some period given below:

  • April 1, 2020 to October 1, 2021 – No registration or license will be required to manufacture, import, distribute or sell Newly Notified Medical Devices;
  • October 1, 2021 to August 10, 2022 – Registration will be required to import or manufacture such medical devices, but no license will be required;
  • August 11, 2022 to August 10, 2023 – License will be required to manufacture, import, distribute or sell Class A or Class B medical devices, but no license will be required to manufacture, import, distribute or sell Class C or Class D medical devices; and
  • After August 11, 2023 – License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.

Shelf Life of Medical Devices

Rule 31 of the Drugs and Cosmetics Rules, 1945, provides that drugs can be imported only when they comply with the purity, quality and strength test. It should be noted that authority will not grant the license if the shelf life of the drugs is less than the 60% residual life, but this requirement can be ignored by the licensing authority if the drugs are imported for following purposes:

  1. Drugs required in emergency situations
  2. Drugs required for the treatment of disease originated in India.
  3. Drugs imported for the testing purposes
  4. Drugs for the charity purpose
  5. Drugs required for outbreak of any unknown diseases
  6. Drugs required for the rare diseases.

New Update on Shelf Life of Medical Devices

Government provided following relaxation related to the shelf life of the medical devices, following are:

  • Less than 90 days, will be allowed to be imported if it has more than 40 % residual shelf-life on the date of import.
  • Between 90 days and 1 year, will be allowed to be imported if it has it has more than 50 % residual shelf-life on the date of import.
  • Is more than 1 year, will be allowed to be imported by the licensing authority if it has more than 60 % residual shelf-life on the date of import.
  • Due to Coronavirus (Covid-19) outbreak the Central Drugs Standard Control Organization (CDSCO) provided a temporary relief till 30th April, 2021 that drugs with a residual life less than 60% can be imported into India provided that importers of these drugs shall give an undertaking that the drugs will be utilized or consumed before the expiry date.

Consequences of not Obtaining Medical Device License

As per latest medical devices rules, 2020 if any manufacturer or importer of medical devices fails to obtain the license until 1, October, 2021 then following actions will be taken against them:

  • Then they have to cease the import or manufacturer the medical devices.
  • The criminal case will be initiated if the medical device is manufactured or sold without the valid license, if found guilty then imprisonment of not less than 3 years may be extended up to 5 years and fine shall not less than Rs.1lakh or 3 times of value of drugs confiscated.

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