The CDSCO has provided the guidance for importing medical device in India. It being stated in the guidance that:
Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.
(2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule:
Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be informed, in writing, to the Central Licensing Authority.
(3) Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject it to evaluation, test or examination, the authorised agent shall pay a fee for such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.
(4) Any subsequent application for,-
(i) grant of licence for additional manufacturing site for the same medical device by the same authorised agent shall be accompanied with a fee and documents as referred in sub-rule (2);
(ii) licence for additional medical device manufactured at the same manufacturing site shall be made by the same authorised agent accompanied with fee as specified in the Second Schedule and respective documents as specified in the Fourth Schedule.
35. Inspection of overseas manufacturing site.— (1) 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.
(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 under sub-rule (1).
36. Grant of import licence.— (1) 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.
(2) In 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 enquiry into the matter, as considered necessary, pass orders in relation thereto within a 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 competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under subrule (1) to the applicant without carrying out clinical investigation.
(4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence 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 as specified under provisions of Chapter VII of these rules.
(5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence 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.
(6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any class of such medical device shall be granted without such permission.
37. Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licenced medical device after completion of every five years from the date of its issue:
Provided that the Central Licensing Authority may permit to deposit the licence retention fee after due date but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem:
Provided further that if the licencee fails to deposit the licence retention fee within the above stipulated period, the licence shall be deemed to have been cancelled.
38. Conditions to be complied with by Licence holder.— (1) The licencee shall comply with the following conditions, namely:-
(i) licence 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 licencee 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 despatch 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 licencee in respect of marketing, sale or distribution of the medical device including withdrawal of 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) licencee 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 of medical device shall be accompanied by an invoice or statement showing the name and quantity of the medical device;
(x) the licencee 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.
39. Fresh application in case of change in constitution. — In case of change in constitution of a licencee, after grant of licence under sub-rule (1) of rule 36, an application shall be made under sub-rule (1) of rule 34 for grant of licence within a period of one hundred and eighty days from the date of such change in constitution:
Provided that the existing licence shall be deemed to be valid till such time, the fresh licence is issued or application is rejected by the Central Licensing Authority.
Explanation.- For the purpose of this rule, the licencee shall include overseas manufacturer who executed the power of attorney in favour of authorised agent.
40. Test licence for import for test, evaluation, clinical investigations, etc.—
(1) Notwithstanding anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the purpose of clinical investigations or test or evaluation or demonstration or training.
(2) The person who desires to import medical device under sub-rule (1), shall apply for an import licence for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule.
(3) On receipt of the application under sub-rule (2), the Central Licensing Authority shall determine, the quantity of the medical devices, after taking into account the requirement for clinical investigation, approved clinical investigation plan, and information and documents submitted by the applicant.
41. Grant of test licence for import for test, evaluation, clinical investigations, etc.— (1) If the Central Licensing Authority, after such enquiry, if any, is satisfied that the requirements of these rules have been complied, the said authority shall grant a test licence in Form MD-17, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application under sub-rule (2) of rule 40.
(2) The medical device for which a test licence has been granted under subrule (1), shall be used exclusively for purposes of clinical investigation, test, evaluation, demonstration or training, as the case may be, and such clinical investigations or test or evaluation or training, shall be conducted at a place specified in such test licence:
Provided that in cases where the medical device is required to be taken to any place other than the ones mentioned in the test licence, the Central Licensing Authority shall be informed in writing before doing so.
(3) The holder of the test licence shall maintain record of the activities undertaken including the name of manufacturer, quantity imported and date of import.
(4) The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of medical device.
(5) A licence in Form MD-17 shall, unless cancelled earlier, be in force for a period of three years from the date of its issue.
(6) The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used, may be permitted to be exported or destroyed under intimation to the Central Licensing Authority.
(7) Where any licencee under sub-rule (1) contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
(8) The Central Licensing Authority shall after giving an opportunity to the licencee to explain, in writing, licencee’s defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
(9) A licencee, whose licence has been cancelled under sub-rule (8), may appeal to the Central Government within forty five days from the date of such order.
42. Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient.— (1) Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by documents required and the fee as specified in the Second Schedule.
(2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant import licence for treatment of patient in Form MD-19.
(3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose of treatment of the patient referred to in sub-rule (1).
(4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of import, name and address of the patient and diagnosis.
(5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect the premises and relevant records and investigate the manner in which the medical device is being used and to take, if required, samples thereof.
(6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking into account the recommendation of the hospital concerned for treatment of patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need.
(7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import of larger quantity of medical devices for use by the patient.
(8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name and quantity of medical device.
43. Import of medical device for personal use.—(1) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions, namely,-
(1) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of such passenger;
(ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so direct;
(iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered medical practitioner;
(iv) the medical device has been prescribed by a registered medical practitioner; and
(v) the medical device so imported shall be accompanied with an invoice or a statement showing the name and quantity of medical device.
(2) Small quantity of medical device, the import of which is otherwise prohibited section 10 of the Act, and which is not forming a part of bonafide personal baggage, may be imported for personal use, on an application made by the applicant in Form MD-20 and such application shall be accompanied by documents confirming that the device is for bona fide personal use and a prescription to that effect by a registered medical practitioner.
(3) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant permission in Form MD-21 or may reject the application for reasons to be recorded in writing within a period of seven days from the date of application under subrule (2).
(4) Medical devices as referred to in sub-rule (2) shall be subject to the following conditions, namely,-
(i) the medical device shall be declared to the Customs Authorities if they so direct; (ii) the consignment of the medical device so imported shall be accompanied with an invoice or statement showing the name and quantity of medical device.
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