The Indian medical device sector, esteemed at USD 4.9 billion, is moderately little yet has seen unprecedented development over the last few years. Developing at a CAGR of 17% over the last five years, the segment is relied upon to keep witnessing double-digit development with a CAGR of 15% in the coming decade.
The Indian medicinal device market offers an incredible opportunity of its size as well as a result of empowering policies and regulations that the Government has acquainted to give a fillip to the medical device industry.
For instance, the government has upgraded the regulatory framework for the medical device in 2017 and has carried it at standard with international norms by presenting the concept of ‘risk-based’ regulation. The regulatory licenses issued for import, manufacture or sale of medical devices have been made never-ending in nature to eliminate on unnecessary and time-consuming paper-work, in an offer to build simplicity of working together in India.
Importing a medical device into India requires fulfillment of few additional legal requirements than those indicated above. The import of all products in India, including medical devices, is represented under the provisions of the Export and Import Policy. The action of import of Notified Medical Devices into India requires an import license from the office of the Drugs Controller General of India. An application for grant of a registration certificate may be made by the foreign manufacturer itself if it has a valid wholesale license for sale or distribution of Notified Medical Devices under the MDR or its authorized agent in India, either having a valid license under the MDR to manufacture for sale of a Notified Medical Device or having a valid wholesale license for sale or distribution of Notified Medical Devices in India. Numerous a times, foreign manufacturers don’t have an Indian subsidiary which has a wholesale license for sale or distribution of Notified Medical Devices. Consequently, the manufacturers select a third party as an authorized agent to influence the application for grant of an import license. The authorization by a manufacturer to its agent in India must be reported by power of attorney.
- Inspection of overseas manufacturing site.— On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.
sub-rule (2) The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure required in connection with the visit to the overseas manufacturing site
- Grant of import licence.— After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application.
In the sub-rule(2) the event of rejection, the applicant may appeal to the Central Government within a period of forty-five days and that Government, may, after such inquiry into the matter, as considered necessary, pass orders in relation thereto within a period of ninety days from the date of appeal.
In the sub-rule (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent 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 clinical investigation.
Where a medical device, is imported from countries other than those referred to in sub-rule (3), the license in case of Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished.
- Validity of license.— A license granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the authorized agent deposits the license retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licensed medical device after completion of every five years from the date of its issue.
Conditions to be complied with by License holder.—
(i) License shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or the State Licensing Authority, as the case may be;
(ii) The licensee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed;
(iii) Authorised agent in cases referred in clause (ii), shall stop immediately the dispatch and marketing of the medical device referred in that clause;
(iv) The Central Licensing Authority, after due consideration of the information as referred in clause (ii), may issue directions to the licensee in respect of marketing, sale or distribution of the medical device including withdrawal of the medical device from the Indian market within a period as may be specified by the Central Licensing Authority;
(v) The authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days;
(vi) In case, no communication of approval or rejection as referred to in clause (v) is received within the stipulated time from the Central Licensing Authority, such change shall be deemed to have been approved;
(vii) Licensee shall inform, any minor change as specified in the Sixth Schedule to the Central Licensing Authority within a period of thirty days, after such minor change took place;
(viii) Authorised agent shall inform the Central Licensing Authority in writing within a period of thirty days in the event of any change in the constitution of the overseas manufacturer or the authorised agent;
(ix) The consignment ofthe medical device shall be accompanied by an invoice or statement showing the name and quantity of the medical device;
(x) The licensee shall supply the medical device for sale or offer it for sale along with its package insert or user manual, wherever applicable.
(2) Where the Central Licensing Authority is satisfied that any medical device is not in conformity with the provisions of the Act and these rules, it may issue directions that the entire batch of such medical device may not be sold or offered for sale or may be recalled from the market including hospitals, if any, where it has been stocked:
Provided that where the Central Licensing Authority considers it necessary or expedient, more than one batch or all batches of such medical device may be directed to be recalled.