BAB VII CHAPTER VII
Pasal 18 Article 18 Direktur Jenderal atau pejabat yang ditunjuk
harus memberikan keputusan persetujuan atau penolakan pendaftaran izin edar alat kesehatan atau PKRT dalam jangka waktu yang dihitung sejak permohonan izin edar dinyatakan lengkap, untuk:
The Director General or appointed official should give the decision of approval or rejection on the registration of the marketing license of Medical Devices or HHP within the period effective as of the date the marketing license application is certified as complete, for:
a. Kelas I: 30 (tiga puluh) hari kerja a. Class I: 30 (thirty) working days b. Kelas lla dan
kelas lIb:
60 (enam puluh) hari kerja
b. Class lla and Class lIb:
60 (sixty) working days c. Kelas III: 90 (sembilan puluh) hari
kerja
c. Class III: 90 (ninety) working days
Pasal 19 Article 19
Nomor izin edar diberikan untuk alat kesehatan dan/atau PKRT yang telah disetujui permohonan pendaftarannya.
The marketing license number is provided to Medical Devices and/or HHP which registration application has been approved.
Pasal 20 Article 20
Terhadap pendaftaran izin edar dikenakan biaya sesuai ketentuan peraturan perundang-undangan.
Costs are charged to the marketing license registration in accordance with the legislative regulations.
Bagian Keempat Fourth Part
Masa Berlaku Izin Edar Validity Term of Marketing License
Pasal 21 Article 21
Izin edar berlaku selama 5 (lima) tahun atau sesuai dengan masa penunjukan keagenan masih berlaku dan dapat diperbaharui sepanjang memenuhi persyaratan
The marketing license is effective for 5 (five) years or according to the agency appointment term, which is still effective, and may be extended as long as the requirements are still complied.
Pasal 22 Article 22
(1) Izin edar dinyatakan tidak berlaku apabila: (1) The marketing license is declared invalid if: a. masa berlaku izin edar habis; a. the validity term of the marketing license
b. masa berlaku sertifikat produksi habis dan/atau dibatalkan;
b. the validity term of the production certificate expires and/or is revoked; c. batas waktu keagenan habis,
dibatalkan, atau tidak diperpanjang; atau
c. the agency time limit expires, is revoked or is not extended; and
d. persetujuan izin edar dicabut oleh Direktur Jenderal atau pejabat yang ditunjuk.
d. The approval of the marketing license is withdrawn by the Director General or by the appointed official.
(2) Pencabutan persetujuan izin edar sebagaimana dimaksud pada ayat (1) huruf d dapat dilakukan apabila:
(2) The approval of the marketing license, as meant in paragraph (1) letter d, may be withdrawn if:
a. alat kesehatan dan/atau PKRT menimbulkan akibat yang dapat membahayakan bagi kesehatan; dan/atau
a. the Medical Devices and/or HHP have consequences that may endanger for health; and/or
b. Tidak memenuhi kriteria sesuai dengan data yang diajukan pada permohonan izin edar.
b. Not complying with the criteria in accordance with the data submitted with the marketing license application.
Bagian Kelima Fifth Part
Perpanjangan Masa Berlaku Izin Edar Extension of the Marketing License Validity Term
Pasal 23 Article 23
(1) Perusahaan pemohon wajib memperpanjang nomor izin edar alat kesehatan dan/atau PKRT selambat-lambatnya 3 (tiga) bulan sebelum habis masa berlakunya.
(1) The applicant company should extend the marketing license number of the Medical Devices and/or HHP not later than 3 (three) months prior to the expiration of the validity term.
(2) Perusahaan yang mengajukan perpanjangan nomor izin edar alat kesehatan dan/atau PKRT setelah habis masa berlakunya, harus memenuhi ketentuan tata cara permohonan izin edar
(2) The company that proposes the extension of the marketing license number of Medical Devices and/or HHP, after expiration of its validity term, should comply with the provision of new marketing license application
baru. procedure. (3) Perpanjangan masa berlaku izin edar untuk
alat kesehatan dan/atau PKRT yang tidak mengalami perubahan data dilakukan dengan memeriksa dokumen terkait yang ditetapkan oleh Direktur Jenderal atau pejabat yang ditunjuk.
(3) The extension of the marketing license validity term for Medical Devices and/or HHP, which data are not changed, is conducted by checking the related documents determined by the Director General or appointed official. (4) Perpanjangan masa berlaku izin edar alat
kesehatan dan/atau PKRT impor yang masa berlaku penunjukkan keagenannya telah habis tetapi belum sampai 5 (lima) tahun dari waktu pengeluarannya, dapat diperpanjang dengan mengajukan surat permohonan perpanjangan disertai dengan surat penunjukkan baru yang diketahui oleh perwakilan Republik Indonesia setempat.
(4) The marketing license validity term of imported Medical Devices and/or HHP, which agency appointment validity term has expired, but not 5 (five) years from its issuance date, may be extended by submitting the request for extension attached by the new appointment letter, which is acknowledged by the local representative of the Republic of Indonesia.
Bagian Keenam Sixth Part
Perubahan Izin Edar Amendment of Marketing License
Pasal 24 Article 24
(1) Perusahaan harus mengajukan perubahan izin edar alat kesehatan dan/atau PKRT terhadap perubahan:
(1) The company should submit the amendment of the marketing license of Medical Devices and/or PKRT on the change of:
a. ukuran; a. size;
b. kemasan; b. packaging;
c. penandaan; c. labelling;
d. Nomor Pokok Wajib Pajak (NPWP). d. Taxpayer Reference Number/NPWP. (2) Perubahan izin edar berdasarkan
perubahan sebagaimana dimaksud pada ayat (1) dilakukan tanpa perubahan nomor izin edar.
(2) The amendment of the marketing license, as meant in paragraph (1), is carried out without amendment of the marketing license number. (3) Perubahan selain sebagaimana dimaksud
pada ayat (2) harus memenuhi ketentuan
(3) The amendment, other than as meant in paragraph (2), should comply with the
tata cara permohonan izin edar baru dengan perubahan nomor izin edar.
provisions of the new marketing license application procedure with the amendment of the marketing license number.
Bagian Ketujuh Seventh Part
Pelaporan Reporting
Pasal 25 Article 25
Perusahaan yang memiliki izin edar alat kesehatan dan/atau PKRT wajib menyampaikan laporan hasil monitoring efek samping secara berkala 1 (satu) tahun sekali, sesuai contoh dalam Formulir 3 sebagaimana terlampir.
The company that possesses the marketing license of Medical Devices and/or HHP should submit the report on the results of monitoring the side effects periodically 1 (one) time a year, according to the sample in Form 3 as attached.
BAB III CHAPTER III
PENANDAAN ALAT KESEHATAN