REGISTRATION OF MEDICAL DEVICES

Medical Devices Rules 2015

By Muhammad Sohail(Pharm-D , R.Ph)

M E D I C A L D E V I C E S

Any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes of,

a) diagnosis, prevention, monitoring, treatment or alleviation of disease;

(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

(c) investigation, replacement, modification or support of the anatomy or of a physiological process;

(d) supporting or sustaining life;

(e) control of conception;

(f) disinfection of medical devices;

(g) providing information by means of in-vitro examination of specimens derived from the human body,

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.

A P P L I C A T I O N P R O C E D U R E F O R M E D I C A L D E V I C E S R E G I S T R A T I O N

(1) An application shall be made by

(a) An establishment having valid licence to manufacture

(b) An importer having valid establishment licence.

(2) On the format as set out in Form-6 or Form-6A.

(3) An application shall be accompanied by

(a)application fee and

(b) information or documents or samples,

APPLICATION PROCEDURE FOR MEDICAL DEVICES

REGISTRATION

(4) The MDB may reject an application, if the applicant fails to deposit fee or provide information.

(5) The manufacturing methods and testing procedures shall conform to the principles of validation.

(6) Complete labeling and prescribing information shall be same as approved in the country of origin or as approved in European Union, USA, Japan, Canada or Australia.

PROCEDURE FOR GRANT OF REGISTRATION OF MEDICAL

DEVICE

(7) Upon receipt of the application form

(a) The MDB may inspect the premises

If the MDB is satisfied it shall register the medical device and enter it in the medical device register.

(b) The registration shall be for a period of five years.

(c) Certificate of registration on Form-7 or Form-7A

RENEWAL OF REGISTRATION OF MEDICAL DEVICE

(1) Renewal on Form-6 or Form-6A sixty days before its expiry and shall be accompanied by

(a)application fee and

(b) information or documents or samples,

(2)The MDB may inspect the premises

If the MDB is satisfied it shall renew the registration for a period of five years from the date of expiry of previous certificate

RENEWAL OF REGISTRATION OF MEDICAL DEVICE

(3) If renewal is made after validity but within sixty days, the applicant shall pay an additional surcharge of ten percent of the renewal fee for registration for each day the application is delayed.

(4) If an application for renewal is made after sixty days of expiry of the period of validity, the application shall be treated as a fresh application for grant of registration.

RENEWAL OF REGISTRATION OF MEDICAL DEVICE

(5) The registration shall continue to be valid until orders are passed on such application if applied before the expiry or within sixty days after expiry.

(6) If an application for renewal is made after sixty days of expiry, the establishment shall be responsible for all the illegal operations.

(7) In case the application for renewal is rejected the MDB, it shall inform the applicant of its decision in writing with reasons of such decision.

CHANGES CONCERNING REGISTERED MEDICAL DEVICE

(1) An application for change on Form-6 or Form-6A and shall be accompanied by fee

(2)The MDB may inspect the premises

(3) If any contravenes its registration may be cancelled or suspended as the MDB may deem fit after giving to the registration holder the opportunity of being heard.

CERTIFICATE OF REGISTRATION OF MEDICAL DEVICE

(1)A certificate of registration shall not be assigned or transferred to any other person or classes of persons except with prior written approval of the MDB.

(2)A certificate of registration issued shall be surrendered to the MDB without demand within fourteen days after the registration of the medical device is cancelled by the MDB

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(1)A registration holder shall comply with the conditions of rules.

(2)The indications, contra-indications, side effects, precautions, warnings, directions for use etc. shall be clearly specified in the labeling and promotion.

(3)Each medical device shall be produced in sufficient quantity.

(4)The manufacture or import of any medical device shall not, without the prior approval of the MDB, be discontinued.

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(5) The importer shall ensure regular and adequate supply of the medical device in Pakistan.

(6)The registration holder or his authorized agent shall for any medical device sold by him issue a warranty thereof on the format as set out in Form-5.

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(7) In respect of new medical device full information regarding following record shall be maintained

(a) clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning that medical device;

(b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that medical device;

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(c) experiences, investigations, studies and tests involving the physical or chemical properties or any other properties of that medical device;

(d) any error in the labeling of that medical device;

(e) any bacteriological or any significant chemical or physical or other change or deterioration in any batch or lot of that medical device;

(f) any failure of one or more distributed batches

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(g) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that medical device; and

(h) any unusual failure

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(8) The following information shall be supplied to the MDB

(a) report in duplicate of all records respecting the information contemplated by clauses (d) and (e)

(b) as soon as possible and in any event within fourteen days, reports in duplicate of all records respecting the information contemplated by clauses (f), (g) and (h).

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(9) If a medical device, at any time, is withdrawn or banned or certain restrictions are imposed in any of the countries, namely, USA, European Union countries, Canada, Japan or Australia, then it shall be the responsibility of the manufacturer in Pakistan or, as the case may be, the importer, to immediately withdraw the medical device from the market in Pakistan or to impose similar restriction and to inform the MDB within fourteen days.

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(10) If a clinical information for a medical device is approved by a regulatory authority in any of the said countries, the same clinical information shall be considered as approved for medical device registration in Pakistan unless modified by the MDB on the basis of scientific data

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(11) If any adverse reaction of medical device, is reported in any of the said countries, it shall be the responsibility of the concerned manufacturer or the importer to report it to the MDB within thirty days.

(12) The manufacturer orthe importer shall supply the information in relation to safety, performance, production, quality or availability of the medical device as and when required by the MDB

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(13) If a person contravenes these rules, he shall after being heard be liable for suspension or cancellation of his registration

(14) On the basis of information received or an inquiry conducted is of opinion that

(a) the registration of a medical device was procured by fraud or misrepresentation; or

CONDITIONS OF REGISTRATION OF MEDICAL DEVICE

(b) the circumstances in which a medical device was registered no longer exist; or

(c) it is necessary in the public interest so to do,

the MDB may, after affording to the registration holder an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration

CANCELLATION OR SUSPENSION OF REGISTRATION OF MEDICAL

DEVICE(1) Before cancellation or suspension the MDB shall issue a show cause notice

(2) The establishment shall submit, reply to the show cause notice within fifteen days.

(3) The MDB, after being satisfied that the establishment has not complied with the conditions of registration or contravened the provision of the DRAP Act may cancel or for a specified period suspend the registration

CANCELLATION OR SUSPENSION OF REGISTRATION OF MEDICAL

DEVICE

(4) The MDB shall inform the establishment, in writing, on the cancellation or suspension of the registration

(5) Where a registration is cancelled by the MDB the establishment shall within fourteen days after being informed in writing of the cancellation return the certificate of registration to the MDB without demand