1

Healthcare Market Entry in Kenya, India, and China

by Victor Joshua Kalalo
Table of Contents
Kenya
Medical Device3
Drug6
India
Medical Device7
Drug8
China
Medical Device.10
Drug.12

Outline
Healthcare Market Entry in China, India, and Kenya
I. Kenya
a. Medical device requirements
i. General provisions
ii. Import requirements
1. Certificate of Conformity
a. Obtaining a CoC
i. Request for certification and determination of
route
ii. Product testing
iii. Inspection
iv. Certification
2. Licensing
iii. Medical regulations
b. Drug requirements
i. Applying for registration
II. India
a. Medical device requirements
i. Devices that require registration
1. Registration
b. Drug requirements
III. China
a. Medical device requirements
i. Device classification
ii. Obtaining a Medical Device Manufacturing Enterprise License
b. Drug requirements
i. Application for registration
ii. Application and approval of new drugs

iii. Application and approval of import drugs

iv. Application of non-prescription drugs

Kenya
Medical Device Requirements
The general provisions for selling, advertising, and packaging medical devices are as
follows: Any device must not cause injury to the health of the user or purchaser when the
device is used according to directions on the label or on a separate document delivered with
the device. Anyone who labels, packages, treats, processes, sells or advertises a device that
goes against any regulations made under Act Cap. 254 "or in a manner that is false, misleading
or deceptive as regards its character, value, composition, merit or safety," is guilty of an
offence. "Where a standard has been prescribed for a device, any person who labels, packages,
sells or advertises any article in such a manner that it is likely to be mistaken for that device
shall be guilty of an offence unless the article complies with the prescribed standard." A device
must be sold, prepared, preserved, packaged, stored, and conveyed for sale under sanitary
conditions.i
Voltage specifications for Kenya need to be considered on devices. Devices need to
conform to Kenyas 240V electric power system or at least provide a switch option between the
U.S. 120V system and Kenya's 240V system. "The trademark name and country of origin must
be displayed in English and/or Kiswahili for all categories of medical equipment." Also,
expiration dates need to be shown for all medical consumables. ii
Medical device testing can be done by the National Public Health Laboratories and
usually involve 400 tests at a cost of about 1,000 dollars. Medical products are accessible to
Kenya if they meet the Kenya Bureau of Standards (KEBS) requirements. KEBS requirements are
being enforced more rigorously than previously due to the Pre-shipment Verification of
Conformity to standards program (PVoC). ii Key elements undertaken in PVoC are: Physical
inspection prior to shipment. Sampling, testing and analysis in accredited laboratories. Audit of
product processes. Documentary check of conformity with regulations. Assessment of
conformity to standards.iii

KEBS implements the PVoC to ensure compliance with the applicable Kenyan standards
and technical regulations or approved equivalents (international standards and national
standards). The Kenyan Government requires that all consignments of regulated products
entering Kenya must obtain a Certificate of Conformity (CoC), which can be obtained from
either Socit Gnrale de Surveillance S.A. (SGS), or Intertek. A CoC is a mandatory Customs
Clearance document in Kenya; consignments arriving at Kenyan Ports without this document
will be denied entry into Kenya.ii
Obtaining a CoC is addressed in the following four paragraphs. PVoC compliance
procedures are designed to provide maximum flexibility to exporters by providing three
possible routes for obtaining a CoC for shipments. The route utilized will depend on the
frequency of the exporters shipments to Kenya as well as the level of compliance they
demonstrate initially when applying for certification. To request for certification, the electronic
Import Declaration Form (IDF) data is to be received from KEBS. The PVoC Country Office in the
country of supply may contact the exporters and provide them with a Request for Certification
form (RFC). The exporter must send the form completed with a pro forma invoice as well as
provide information about the date and place of inspection. The exporter joins to the RFC form
the test reports and, when applicable, copies of the Statements of Registration and/or License.
The PVoC Country Office will review the RFC and attached documentation and will confirm the
applicable route for certification and the standards applicable. iii
The PVoC Country Office will arrange for product sampling and testing with an approved
or "an ISO/IEC 17025 accredited" laboratory before the scheduled date of shipment, and the
exporters should wait for test results before shipping. "Where the Exporter wishes to provide
test certificates, these should be from a laboratory accredited to an ISO/IEC system or other
approved laboratories." The exporters can also make arrangements to have a PVoC Agent staff
witness the tests. Test reports, along with a copy of the Laboratory Accreditation, must be
submitted to the PVoC Country Office. The test reports must be detailed enough in order to
"demonstrate tractability to the consignment" that is to be shipped to Kenya.iii
The PVoC Country Office will contact the place of inspection. It will then confirm the
appointment for physical inspection of the consignment. Physical inspection is normally carried

out to verify requirements that may be virified visually, such as product labelling, and to
"ensure reconciliation of the consignment with previously submitted test reports." If applicable,
product sampling for testing purposes might also occur during the physical inspection. In such
cases, exporters should wait for test results before shipment. iii
Except for air-shipments, the exporters will submit a final invoice to the PVoC Country
Office as soon as possible after physical inspection. The PVoC Country Office will perform a final
review of all inspection and test reports and "decide upon the issuance of the Certificate of
Conformity (CoC) or Non Conformity Report (NCR)." PVoC Country Office will indicate any
corrective actions needed prior to the issuance of a CoC. Only after any discrepancies are
corrected, a CoC will be issued.iii
The following documentation is required in order to import medical equipment: import
declaration form (IDF), commercial invoice, airway bill ((air freight) or bill of lading (sea freight),
and pre-shipment inspection Clean Report of Findings (CRF).ii
Any import with a free on board (FOB) value over 5,000 dollars will have to a preshipment inspection at the port of shipment. Pre-shipment inspection may be done by SGS. A
pre-shipment inspection costs 2.75% of the accumulative cost, insurance, and freight (C.I.F)
value, which is payable as an IDF processing fee. Unless indicated, freight is calculated at 18.5%
of the consignment cost, and insurance at 1.5% of the sum of the consignment cost and
freight.ii
Medical equipment is usually exempt from import duties and value added tax (VAT).
Exceptions to this include microscopes, dental chairs, and liquid-filled clinical thermometers. No
approval is required to import any kind of irradiation device. Prior to installation of any
irradiation device, the Radiation Protection Board must conduct an inspection and grant a
license.There is no ban on the import of any type of pre-owned (meaning used and refurbished)
medical equipment to Kenya, as long as performance characteristics conform to the
International Standards Organization (ISO). ii

Drug Requirements
A drug may be registered for 5 years in Kenya, after which the company must apply for
renewal. Initial applications for the registration of a drug are assessed based on safety, efficacy,
and quality. Registration applications must include the following information:
1. administrative data;
2. pharmaceutical formula;
3. name and structural formulas of the active ingredients;
4. specifications of ingredients;
5. analytical control ingredients;
6. analytical control procedures during manufacture;
7. shelf life;
8. summary of the method of manufacture;
9. summary of experimental tests for pharmacological effects
10. summary of tests for physiological availability; and
11. summary of clinical tests for efficacy. iv
Also, applications must include labels, package inserts, and any promotional literature.
The label should include the following information:
1. therapeutically active substances, specified by name, quantitatively and qualitatively,
per suitable unit;
2. inactive ingredients, which "may be specified under a common term such as
"excipients" unless such ingredients may be of some special significance in the use of
the product;"
3. name and percentage of any bactericidal or bacteriostatic agent;
4. expiration date;
5. batch number;
6. where necessary, directions of a technical nature for the use of the product;
7. particulars on the normal dose and indications;
8. name and business address of manufacturer; and

9. registration number of the product. iv

Kenya does not require package inserts, but if any company chooses to include one, it
must be approved by the Ministry of Health. "All changes to the approved labeling must also be
reviewed b the Ministry."iv

India
Medical Device Requirements
Medical devices and surgical instruments are not, as of September 2012, covered under
regulatory framework in India. Any device that is intended for internal or external use in the
"diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or
animals, as may be specified by the Central Government by notification in the Official Gazette,
would be considered a drug under the D&C (Drugs and Cosmetics) Act" and provisions of Drugs
and Cosmetics Act and Rules "made therein would be applicable on such a device." v
It takes approximately six to nine months to complete medical device registration in
India. Once granted, medical device registrations are valid for three years in India. Before 2005,
only medical devices such as tubal rings, metered dose inhalers, condoms, and disposable
hypodermic syringes required registration in India. In India, the Central Drugs Standard Control
Organization (CDSCO) is the main regulatory body currently regulating the import, sale and
manufacture of medical devices which have been notified as drugs under the Drugs and
Cosmetics Act. "The CDSCO lays down standards of drugs, cosmetics, diagnostics, and devices
and issues licenses to drug manufacturers of new drugs, clinical research in India and standards
of imported drugs etc." The CDSCO has set up a separate division, the Medical Device Division,
in order to facilitate matters related to "notified medical devices." v
The following notified medical devices are considered drugs under Section 3, Clause (b),
Sub clause (iv) of the Drugs and Cosmetics Act and require registration: disposable hypodermic
syringes, disposable hypodermic needles, disposable perfusion sets, in vitro diagnostic devices
for HIV, HBsAg, and HCV, cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V.
cannulas, bone cements, heart valves, scalp vein set, orthopedic implants, and internal

prosthetic replacements. In addition, the following products are regulated as drugs under the
Drugs and Cosmetics Act and also require registration: blood grouping serums; skin ligatures,
sutures, and staplers; intra uterine devices (Cu-T); condoms; tubal rings; surgical dressings;
umbilical tapes; and blood/blood component bags.vi
For any device listed in the paragraph above, an India Authorized Agent must be
appointed to interact with the CDSCO on the applicant's behalf. The agent must maintain a drug
wholesale license and be a resident of India or maintain a place of business within the country.
In addition to being a resident of India, the India Authorized Agent representative must have
prior experience in the industry. The agent is legally liable for the product in India. "The India
Authorized Agent is granted, through Power of Attorney by the manufacturer, authorization to
submit medical device registration documents" and act as a contact for any inquiries related to
the device asked by the CDSCO. In addition, the agent is involved in vigilance activities and acts
on the manufacturer's behalf "if an onsite inspection of the manufacturer's facility is
required."vii
For any device listed above, file application for Device Registration Certificate to CDSCO
using Form 40. Schedules D-1 and D-2 must also be included, "as well as verification of
compliance with US, Canadian, European, Japanese or Australian medical device regulations."
Device manufacturers new to India require a Form 45 (New Drug License) in addition to the
Form 40 application. Manufacturers must then obtain a Registration Certificate Form 41, which
is valid for up to three years, from the CDSCO. Manufacturers must then identify their
distributor in India (holding forms 20B and 21B). Then, manufacturers must apply for Import
License using Forms 8 and 9 from the CDSCO. The chosen distributors must be identified on
these forms. Lastly, manufacturers must obtain an Import License (Form 10), which is valid for
three years, from the CDSCO.viii
Drug Requirements
Applicants are required to "file application in Form 44 along with prescribed fees in the
form of treasury Challan and all relevant data as per Schedule Y to Drugs and Cosmetics Rules,"
in order to seek permission to import or manufacture new drug substances and its formulations

for marketing in the country. Documents include chemical and pharmaceutical information,
animal pharmacological and toxicological data, clinical data of safety and efficacy regulatory
status in other countries, and results of clinical trials on local population.

ix

If the new drug is approved in other countries, the requirement of submitting the results
of clinical trials of the local population may not be necessary "if the drug is of such a nature that
the licensing authority may, in public interest, decide to grant such permission on the basis of
data available from other countries." The submission of requirements relating to perinatal
studies, teratogenic studies, reproduction studies, animal toxicology, mutagenicity and
carcinogenicity data "may be modified or relaxed in case of new drugs approved and marketed
for several years in other countries and adequate published evidence regarding the safety of
the drug is available."ix
"As per Clause 1(3) of Schedule Y to Drugs and Cosmetics Rules, for drugs indicated in
life threatening or serious diseases or diseases of special relevance to the Indian health
scenario," the toxicological and clinical data requirements may be deferred, abbreviated or
omitted, "as deemed appropriate by the licensing authority." "Life-threatening" diseases are
considered "diseases or conditions where the likelihood of death is high unless the course of
the disease is interrupted and diseases or conditions with potentially fatal outcomes." Diseases
such as cancer and AIDS are generally considered life-threatening diseases.ix
CDSCO will examine applications for drugs treating life-threatening diseases, and if any
particular information is lacking, "it will be informed to the applicant or else the applications
will be forwarded to the members of IND in case of investigational new drugs (INDs) or to the
members of New Drug Advisory Committee (NDAC)" in the case of a new chemical entity other
than an IND and new fixed doe combinations. ix
In the case of applications for granting approval of new dosage form, new indication,
new route of administration, etc. of approved drugs, the CDSCO will examine the application.
Where required, such applications may also be examined in consultation with an expert or
expert committees. "All requests for exemption of toxicological & clinical data requirements
will be considered on the basis of examination and scrutiny of the adequacy of data and in

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consultation with experts." A legal undertaking in the form of an affidavit should be submitted
by the applicant stating that the data submitted along with the application is "scientifically valid
and authentic."ix

China
Medical Device Requirements
China's Food and Drug Administration (CFDA, formerly known as the State Food and
Drug Administration, SFDA) classifies medical devices into three categories according to their
risk potential:

Class I medical devices are devices whose safety and effectiveness can be ensured
through routine administration.

Class II medical devices are "those for which further control is required to ensure their
safety and effectiveness."

Class III medical devices are those that are implanted into the body, or used for life
support or sustenance, or pose potential risks to the human body, "and thus must be
strictly controlled with respect to safety and effectiveness."x
The clinical trials of new Class II and Class III devices can only be conducted after clinical

trial approval by the relevant authority in accordance with the rules of the drug regulatory
authority under State Council. New medical devices that have completed clinical trials and
passed the evaluation and review of experts organized by the drug regulatory authority under
State Council, "shall receive a new product certificate after being approved by the same
organization." Clinical evaluation must be conducted for Class II and Class III medical devices
before they are put into production. Clinical trial or verification shall be conducted at medical
institutions designated by the drug regulatory authorities of the government at provincial level
and above. The medical institutions shall conduct the clinical trial or verification in accordance
with the related provisions of the drug regulatory authority under the State Council. xi
When importing medical devices into China for the first time, the agent of the imported
device should submit "the instruction for use, quality standards, testing methods, other

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relevant information, product samples, and marketing authorization certificates issued by the
manufacturing countries (regions)," for inspection and approval by the drug regulatory
authority under the State Council, and receive an import product registration certificate before
applying for customs formalities. xi
When applying for registration of medical devices, testing reports, technical standards,
and other relevant information shall be submitted according to provisions of the drug
regulatory authority under the State Council. "The drug regulatory authority of the government
of the municipality consisting of districts shall decide within 30 working days i f the product can
be registered, counting from the date of acceptance of the application." If the product is not
approved for registration, then a written explanation will be given to the applicant. "The drug
regulatory authority of governments of provinces, autonomous regions and municipalities
directly under central government shall decide within 60 working days if the product can be
registered, counting from the date of acceptance of the application." If the product is not
approved for registration, then a written explanation will be given to the applicant. "The drug
regulatory authority under the State Council shall decide within 90 working days if the product
can be registered, counting from the date of acceptance of the application." If the product is
not approved for registration, then a written explanation will be given to the applicant. xi
In case any situation reflected in the content of the registration certificate is changed,
the holder of the certificate shall apply for an amendment of the certificate or for reregistration within thirty working days of the change. xi
The term of validity for the registration certificate of medical devices is four years. The
holder of the certificate should apply for re-registration within six months before the certificate
expires. When the manufacturing of a medical device is stopped continuously for at least two
years, "its registration certificate is automatically invalidated." xi
Enterprises manufacturing medical devices shall meet the following standards:
1. possess professional technical personnel required for the manufacture of its medical

devices;
2. possess facility and environment required for the manufacture of its medical devices;

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3. possess equipment required for the manufacture of its medical devices;
4. possess an establishment and equipment for quality testing required for the

manufacture of its medical devices. xi

Establishment of manufacturing of Class I medical devices requires "that the enterprise
file a record with the drug regulatory authority of provinces, autonomous regions and
municipalities directly under the central government," who will issue a Medical Device
Manufacturing Enterprise License. The industrial and commercial authority will not issue a
business license to enterprises which have not received a Medical Device Manufacturing
Enterprise License. The term of validity of the Medical Device Manufacturing Enterprise License
is five years. Once it has expired, re-inspection and license renewal shall be conducted.
Enterprises will not start manufacturing products until obtaining the Medical Device
Manufacturing Enterprise License. xi
Establishing the distribution of Class II and/or Class III medical devices requires that the
enterprise "file a record with the drug regulatory authority of provinces, autonomous regions
and municipalities directly under the central government, who will then issue a Medical Device
Distributing Enterprise License."xi
Drug Requirements
The applicant shall provide sufficient and reliable research data to prove the safety,
efficacy and quality of the drug, "and be liable for the authenticity of all the dossiers
submitted." During the process of registration, the drug regulatory department will "conduct
on-site inspection and casual inspection to the non-clinical studies and clinical trials,' in addition
to production site inspection for the pre-marketing approval to confirm the authenticity,
precision, and integrity of the dossier submitted. xii
The applicant will provide the information on patent and its ownership of the applicant
or other parties in China, "in respect of the drug applied for registration, its formula,
manufacturing processes and/or uses, etc." If another party owns the patent in China, then the
applicant will provide a statement of non-infringement. The drug regulatory department shall
publish the information or the statement submitted by the applicant on its official website. If a

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patent dispute occurs in the process of drug registration, then it will be settled in accordance
with relevant laws and regulations on patent.xii
For a drug patented in China, applicants other than the patentee may submit the
application for registration two years prior to the expiration of the patent. The CFDA will
"review the drug application in accordance with the provisions, and after the expiry date of the
patent, check and issue the drug approval number, Import Drug License or a Pharmaceutical
Product License if the application conforms with the provisions." After obtaining the drug
approval number, the applicant shall manufacture according the manufacturing processes
approved by the CFDA.xii
The CFDA may consider special review and approval in cases of the following
applications:
1. active ingredients extracted from plants, animals and minerals, etc. and their

preparations not yet marketed in China, and "newly discovered Chinese crude drugs and
their preparations;"
2. chemical drug substances and their preparations and biological products not yet

approved for marketing in China or abroad;

3. "new drugs for the treatment of diseases such as AIDS, malignant tumors and rare

diseases, etc. with significant clinical advantage;" and

4. new drugs for the treatment of diseases, for which effective therapeutic methods are

not available.
For drugs specified in the previous clause, applicants may apply for special review and approval
in the process of drug registration. "Specified measures for special review and approval shall be
formulated separately."xii
After completing the pre-clinical study, the applicant shall fill the Application Form for
Drug Registration and "report authentically relevant materials to the drug regulatory
department of the province, autonomous region or municipality directly under the Central
Government where the applicant is located." Drug regulatory departments of provinces,
autonomous regions, or municipalities directly under the Central Government shall conduct the

14

preliminary review of the application dossiers, and issue an acceptance notice of drug
registration application if requirements are met or issue a non-acceptance notice, which will
give reasons for not meeting requirements. xii
On-site inspections of the drug research and development conditions and raw data will
be conducted within five days from the date they accept an application by the drug regulatory
departments of provinces, autonomous regions, or municipalities directly under the Central
Government. They will also make a preliminary review of the submitted dossiers, and provide
review options within five days from the date they accept an application. If the drug being
registered is a biological product, then samples from three production batches will also be
collected for testing, and "a notice for the testing for registration shall be issued to the drug
testing institute." The drug testing institute will "test the samples according to the drug
specifications submitted by the applicant, verify the submitted drug specifications, and submit a
certificate of analysis for drug registration" to the Center for Drug Evaluation of the CFDA and
copy to the applicant.xii
After receiving submitted dossiers, the Center for Drug Evaluation will "organize
pharmaceutical, medical and other technical personnel to conduct technical review of the
submitted dossiers within the specified timeline, and may request, with reasons, applicants to
provide supplementary materials when necessary." After completing technical reviews, the
Center for Drug Evaluation will give technical review opinions and reports, together with
relevant documents, to the CFDA. The CFDA will make review and approval decisions based on
the technical review opinions. If the regulations are conformed to, then a Drug Clinical Trial
Approval shall be issued. If the regulations are not conformed to, then a Disapproval Notice will
be issued with reasons being provided. xii
A drug applying for importation "shall have already obtained the drug marketing
authorization in the product in country or region where the overseas pharmaceutical
manufacturer is located." Those that have not yet obtained marketing authorization in the
producing region, "however confirmed with safety, efficacy and clinical needs" by the CFDA
may be approved for importation. The production of a drug applying for importation must

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comply with the GMP requirements of both the producing region where the drug manufacturer
is located and China.xii
To apply for import drug registration, the applicant will "fill the Application Form for
Drug Registration, submit relevant dossiers and samples, provide relevant approval
documents," and submit the application to the CFDA. The CFDA will conduct the preliminary
review of the application dossiers, "and issue an acceptance notice of drug registration
application and notify the National Institute for the Control of Pharmaceutical and Biological
Products to conduct testing for registration of samples from three batches if requirements are
met." If requirements are not met, then the CFDA will issue a non-acceptance notice of drug
registration application with reasons. xii
The CFDA may organize to conduct on-site inspection of development and production
conditions, and take samples. The National Institute for the Control of Pharmaceutical and
Biological Products will "organize to conduct the testing for drug registration within five days
from the date it receives the dossiers and samples."xii
The drug testing institutes "undertaking the import drug testing shall complete the
testing for registration and submit the certificate of analysis for drug registration to the
National Institute for the Control of Pharmaceutical and Biological Products within 60 days"
from the date they receive documents, samples and relevant reference standards. Sample
testing and verification of specifications for controlled drugs or vaccines shall be completed
within 90 days.xii
After a clinical trial is complete, the applicant will fill the Application Form for Drug
Registration, submit the clinical trial data, other altered and supplementary data in accordance
with regulations, give in detail the basis and reasons, and provide relevant approved
documents. The Center for Drug Evaluation will "organize pharmaceutical, medical and other
technical personnel to conduct comprehensive review of the submitted clinical trial data within
the specified timeline, and may request, with reasons, applicants to provide supplementary
materials when necessary." The CFDA will make a review and approval decisions based on the
general opinion. An Import Drug License will be issued if regulations are conformed to. "For a

16

drug applied for registration by a drug manufacturer in Hong Kong, Macao or Taiwan of China,
its application shall be handled in reference to the application procedures for import drug
registration." If requirements are met, then a Pharmaceutical Product License will be issued. If
requirements are not met, then a Disapproval Notice will be issued with reasons. xii
If the applied generic drug is regulated as a non-prescription drug, then the applicant
will indicate the item of non-prescription drug in the "additional application items" of the
Application Form for Drug Registration. If the applied generic drug is regulated as both a
prescription and non-prescription drug, then the applicant may submit an application for either
a prescription or non-prescription drug according to the respective requirements. xii
For any of the following circumstances, the applicant may indicant the item of nonprescription drug in the "additional application items" of the Application Form for the Drug
Registration. If the relevant requirements for non-prescription drugs apply, then the drug will
be review and approved, "and regulated as a non-prescription drug; if relevant requirements
for non-prescription drugs do not apply, it shall be review and approved," and regulated as a
prescription drug:
1. To alter the dosage form of a non-prescription drug determined by the State Food and

Drug Administration without changing the indications or functions, dosage and route of
administration; or
2. To formulate a new fixed dose combination using active ingredients of non-prescription

drugs determined by the State Food and Drug Administration.xii

For the registration application of an import drug categorized as non-prescription drug,
the application, review , and approval procedures for import drugs will apply, and the
technological requirements will be the same as those for the domestically produced nonprescription drugs.xii

http://www.kenyalaw.org:8181/exist/kenyalex/actview.xql?actid=CAP.%20254

ii

http://www.ita.doc.gov/td/health/Medical%20Devices%20Kenya%202008.pdf

iii

http://www.intertek.com/uploadedFiles/Intertek/Divisions/Oil_Chemical_and_Agri/Media/pdfs/Kenya%20Import
er%20and%20Exporter%20Guidelines.pdf

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iv

https://www.princeton.edu/~ota/disk1/1993/9321/932111.PDF
http://www.lexology.com/library/detail.aspx?g=e39ba922-f7c6-4568-a7e0-9b753769ada6
vi http://www.emergogroup.com/files/india-list-of-notified-medical-devices.pdf
vii http://www.emergogroup.com/services/india/indian-authorized-agent-representative
viii http://www.emergogroup.com/resources/india -process-chart
ix http://www.biospectrumasia.com/biospectrum/regulatory/22511/how-drug-registered-india
x http://www.tuv-sud.com/industry/healthcare-medical-device/market-approval-certification-for-medicaldevices/the-regulatory-approval-process-for-medical-devices-in-china
xi http://www.emergogroup.com/files/china-medical-device-regulations.pdf
xii http://eng.sfda.gov.cn/WS03/CL0768/61645.html
v